Minutes of 244th Meeting of Registration Board

Minutes for 244th Meeting of Registration Board held on 22-
23rd July, 2014.

Item No. Detail of Item Page No(s)
Item No.I Confirmation of minutes of 243rdmeeting Registration Board 04
Item No.II Agenda point referred by Dr. Amanullah Khan (Director DTL, Quetta) - 05
Hepatitis C drug marketed without approval.
Item No.III Writ Petition filed by M/s Friends Pharma, Lahore for grant of Vitamin 05-17
Preparations.
Item No.IV Approval of clinical trial effectiveness of Antibiotic prophylaxis during 18-19
surgical evacuation of the uterus for miscarriage management in low
income countries: A Multinational, Randomized, Double-Blind Placebo-
Controlled Trial.
Item No.V Registration of drugs (cases referred by Pharmaceutical Evaluation cell) 20-177
Item No.VI Miscellaneous Cases 178-208
Item No.VII Biological Drugs 208- 242
Item No.VIII Quality Control cases 242-258
Item No.IX Medical Devices 258-268
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244th meeting of Registration Board was held on 22-23rd July,2014 in the Committee
Room, M/o National Health Regulation Services and Coordination, Islamabad. The meeting was
chaired by Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration
Division. The meeting started with the recitation of Holy Verses. The meeting was attended by
the following:-
1. Lt General (R) Karamat Ahmed Karamat. Member

2. Brig (R) Dr. Muzammil Hasan Najmi Member
Associate Dean, Basic Sciences Division,
Foundation Medical University, Rawalpindi.
3. Brig. Dr. Aslam Khan Member
Professor of Medicine, Military Hospital Rawalpindi.
4. Mr.Jamil
awalpindi.Anwer Member
Director Drugs Testing Laboratory
Government of Punjab, Lahore.
5. Mr.Abdul Razak Member
Government of Sind, Karachi.
6. Mr.Abid Hayat Member
Representative of Director Drugs Testing Laboratory
Government of Khyber Pakhtoonkhwa, Peshawar.
7. Dr.Amanullah Khan Member
Government of Baluchistan, Quetta.
8. Sheikh Ansar Ahmad Member
Director Biological, DRAP.
9. Dr. Noor Muhammad Shah Member
Director MD&MC, DRAP.
10. Mr. A.Q.Javed Iqbal Member
Director QA&LT, DRAP.
11. Dr. Obaidullah Secretary/Member
Deputy Director General (Reg-I).
Dr. Tariq Siddique (DDG R II), Ahmad Din Ansari (DDC QC), Muhammad Arif (DDC
R I), Muhammad Amin (DDC R V), Faisal Shahzad (DDC BD), Khalid Mehmood (DDC QC),
Babar Khan (Incharge, PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD), Muneeb
Ahmad Cheema (ADC), Ammad Zaka (ADC), Atiq ul Bari (ADC), Sara Mehreen (ADC) and
Muhammad Ansar (ADC) assisted relevant Directors and Secretary of the Board with agenda.
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Mr.Shafiq Ahmad Abbasi, Dr.Muner Anwar, Mr.Nadeem Alamgeer and Mr.Asif Aziz
Akhai attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA
respectively.
In addition to routine agenda, the Board discussed various other matters and following
decsions were also taken:
Registration Board was apprised that Pharmaceutical Evaluation & Registration division
has prepared a list of registration applications in order of date of submission and has
placed on DRAP,s website. Registration Board endorsed that these applications will be
considered on principal of FIFO (First In first Out). However, registration applications
for for new drug molecule / dosage form / strength / combination will also be considered
separately on same principal of FIFO as a separate category. It was brought to the notice
of the Board that generic products of some molecules have been considered by the Board
for new licensees but brand leader ,s products are still not scrutinized. The Board advised
PEC to evaluate such registration applications of brand leaders on priority.
The Board decided that if an imported drug is not on free sale in its respective country of
origin / manufacture, such product will be registered in Pakistan if the product
manufactured in the applied facility is approved by any of the regulatory authorities from
USFDA, EMA, Australian TGA or PMDA Japan.
Registration Board advised Pharmaceutical Evaluation Cell to scrutinize all new drug
molecule / dosage form / strength / combination in light of decision already taken in 240th
meeting for such cases.
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Item No I: Confirmation of minutes 243rd meeting Registration Board.
243rd meeting of Registration Board was held on 08-09th May, 2014 and minutes were
circulated to all members through e-mail. Two members forwarded their comments, as follows:
A. Dr. Amanullah Khan (Director DTL, Quetta):
a. The matter regarding biological products of the inspected firms have been discussed in
length and the entire board is of the opinion to first safe guard the health of our patients and then
encourages our pharmaceutical industry for the transfer of biological technology to manufacture
safe and quality biological products for the country. However nobody is allowed to use the lives
of our country man for experimental basis, therefore all the biological drugs manufactured in the
country should be safe and effective to treat the ailment of our people. As all we know that
scientifically we have capable and well equipped pharmaceutical companies in the country which
are in a position to carry out manufacture of safe and quality biological products in the country.
b. The draft minutes of 243rd DRB to my understanding is to submit CoPP/GMP and bio
comparable data and I also understand that bio-comparability refers to in-vitro-comparison
which is acceptable. But it is beyond my understanding that why it is written that the 242 nd DRB
decision is upheld and it needs clarification because the decision of 242 ndminutes in biological
products was not approved by majority of the board members. Therefore, changes should be
made and decision of 243rd RB should supersede the decision made in 242 ndRB for biological
products.
B. Mr. Abdul Razzaq (Director DTL, Karachi):
Please remove the decision made in 242ndRegistration Board meeting for biological as it
was quarantined, uphold only decision made in 243 rdRegistration Board meeting. Decision made
for biological products only those raw material should be imported and used that are also in use
for the manufacture of finished drug in the country of origin should be suspended, since there
are number of products which are developed by companies for export purposes only and they are
marketing these products internationally. Similarly we have given privilege to manufacture in
Pakistan that for meeting export requirements of a local manufacturer or a foreign
pharmaceutical company, drug can be contract manufactured but such drugs shall not be sold in
Pakistan.
Decision: Registration Board was apprised that above points are part of agenda of
instant meeting and will be discussed under biological drugs. Minutes of 243 rd meeting
were confirmed by the Board.
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Item No II: Agenda point referred by Dr. Amanullah Khan (Director DTL, Quetta) -
Hepatitis C drug marketed without approval.
Dr. Amanullah Khan (Director DTL, Quetta) has referred to news published in the News
dated Jun 27, 2014 captioned Hepatitis C drug marketed without approval and requested that
case may be placed in agenda of Registration Board meeting for discussion. The report pertains
to registration of Ropegra injection for M/s Roche, Karachi.
Decision: Registration Board discussed the News report dated Jun 27, 2014 and
advised Biological Division to bring record regarding registration of Ropegra injection in
forthcoming meeting. Moreover, officers who processed the case will brief the Board about
proceedings of registration of Ropegra injection.
Item No. III. Writ Petition filed by M/s Friends Pharma, Lahore for grant of Vitamin
Preparations.
M/s. Friends Pharma (Pvt.) Ltd; Lahore has filed a writ petition No. 16015-14 in Lahore
High Court, Lahore against DDG Lahore, FID, Lahore, CQC, Islamabad, Drug Registration
Board, Drug Controller and Chief Executive of Drug Regulatory Authority of Pakistan,
Islamabad due to the reason that approval of their below mentioned vitamin preparations could
not be communicated to the firm. The Lahore High Court, Lahore has decided the case on 06-06-
2014 as under:
In view of the request made by the learned counsel, the respondent No.5 is directed to
decide the above applications of the petitioner, if pending, strictly in accordance with
law, after affording opportunity of hearing to all concerned; and, through a well reasoned
speaking order as expeditiously as possible preferably within a period of two months fom
receipt of a certified copy of this order.
It is submitted that the Me-to Committee of Registration Board in its 195 th (A) approved
following products as under:-
S. No. Name of Drug(s) with composition Pack Demanded Decision of the

size MRP Board.
1. Theramin Tablets 20s Rs. 110.00 Approved
Vitamin D.500 I.U. subject to
Vitamin B1100mg standard
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Vitamin B6100mg. formulation
Vitamin B12. 10mcg.
Vitamin C.. 100mg
Vitamin E.. 10mg.
Nicotinamide. 10mg.
Calcium Glycrophosphate.. 350mg.
Folic Acid B.P.. 1mg.
Biotin.50 mcg.
Zinc500mcg
Ferrous Gluconate 250mg.
2. Theramin-T 20s Rs. 90.00 -do-

Vitamin A................ 5000 I.U.
Vitamin D................ 500 I.U.
Vitamin B1................ 10mg
Vitamin B2................ 10mg.
Vitamin B6................ 2 mg.
Vitamin B12................ 4mcg.
Vitamin C................ 300mg.
Nicotinamide................ 10mg.
Calcium Pantothenate................ 20mg.
Calcium (as Carbonate)................
50mg.
Magnesium (as oxide)................ 6mg.
Iron (as ferrous fumerate)................
10mg.
Copper................ 1mg.
Iodine................ 0.15mg.
Manganese (as sulphate)................
1mg.
Potassium (as Sulphate)................ 5mg.
3. Theramin- S 20s Rs. 130.00 -do-

Vitamin A................ 5000 I.U.
Vitamin D................ 400 I.U.
Vitamin B1................ 2.18mg
Vitamin B6................ 2.6mg.
Vitamin B12................ 9mcg.
Vitamin C................ 120mg.
Vitamin E................ 30 I.U.
Calcium Pantothenate................
10.87mg.
Folic Acid................ 0.4mg.
Biotin................ 45mcg.
Calcium................ 3mg.
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Magnesium................ 10mg.
Iron................ 27mg.
Copper................ 3mg.
Iodine................150mcg.
Mangnese................ 7.5mg.
Potassium................ 7.5mg.
Zinc................ 22.5mg.
Phosphate................ 10.5mg
4. Theramin Fort 30s Rs. 170.00 -do-

Vitamin A................ 5000I.U.
Vitamin D................ 500 I.U.
Vitamin B1................ 10mg
Vitamin B2................ 10mg.
Vitamin B6................ 2mg.
Vitamin B12................ 4mcg.
Vitamin C................ 300mg.
Vitamin E................ 50 I.U.
Magnesium as (oxide)................ 6mg.
Iron................ 10mgm.
Copper as (Sulphate)................ 1mg.
Iodine................0.15mg.
Mangnese as (Sulphate)................ 5mg.
Potassium as (Sulphate)................ 5mg.

Calcium as (Carbonate)................
50mg.
Zinc................ 10mg.
Selenium................ 10mg.
Chromium................ 10mg.
5. Vitabex-C 20s Rs. 78.00 -do-
Vitamin A................ 10,000 I.U.
Vitamin B1................ 10mg
Vitamin B6................ 50mg.
Vitamin B2................ 10mg.
Vitamin B12................ 10mcg.
Vitamin C................ 250mg.
Vitamin E................ 70I.U.
Nicotinamide ................ 7.5mg
6. Vita-S Tablets 30s Rs. 140.00 -do-
Vitamin A................ 5000 I.U.
Vitamin D................ 100 I.U.
Vitamin C................ 300mg.
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Vitamin E................ 60I.U.
Copper (as oxide)................ 2mg.
Folic Acid................ 200mcg.
Selenium................ 50mcg
Zinc (as oxide)................ 40mg
It is submitted that the Registration Board in its 187 th meeting held on 25th& 26th
November, 2004 constituted a Me-too Committee in line with the sub rule 6 of rule 24 read with
sub rule 7 of rle 8 of the Drug Licensing Registration and Advertising Rules, 1976 for
consideration / disposal of applications of me-too drugs with following conditions and the
Registration Board 191st meeting held on 30th 31st May, 2005 extend the tenure of same
committee for a period of (1) one year on the same terms of references:-
i. The Committee would comprise of the members of the Registration Board and
would hold office for a period of three months.
ii. The committee would meet once a month or more often if required to consider the
applications for registration of generic brands.
iii. The applications complete in all respect would be given consideration.
i. The recommendations of the committee will be submitted for final approval of the
Chairman of Registration Board who had been authorized by the Board.
ii. The above decision would be submitted before the next meeting of the
Registration Board for the information/ratification.
As per TORs of committee at mentioned at Sr. iv, this decision was to be approved by
Chairman Registration Board but in the next meeting of Registration Board i.e 196 th meeting, it
was decided to defer all vitamin preparations till finalization of policy. As vitamins policy is
pending till to date, therefore, above decision of Registration Board could not be communicated
to the firm.
In view of the above, it proposed that vitamin policy may be finalized to dispose of
instant case in light of the decision of Lahore High Court, Lahore.
The Registration Board in its 217th meeting approved the following policy for registration
vitamin preparations:-
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Registration Board in its 216th meeting had considered following recommendations for
finalization of vitamin policy, as under: -
a) PPMA & Pharma Bureau collectively adopted a stand that vitamins shall
remain under the Drugs Act, 1976.
b) That the formulations approved by the Regulatory Authorities of the
developed countries will remain register in the identical strengths of active
ingredients with special focus on the optimum level of the Vitamin A,
Vitamin D, Vitamin E and certain Trace Elements which exhibit toxicity
because the dietary habits of Pakistan population are full of the Vitamins.
It will be mandatory that free sale certificate would be submitted to the
Ministry of Health for continuation of the formulation or new registrations
identical.
c) The formulations which were registered up to December, 1997 will also
remain in the market. However, their ingredients strength levels will be
rationalized at uniform formula.
d) Rest of the formulations will be reviewed in the light of Para b & c. In
case of formulations not in line with the b & c, the firms will be allowed
to adopt similar formulations available in the light of the Para b & c or
surrender the formulation.
e) All the pending applications will be decided in the light of Para b & c.
f) Mandatory stability studies along with validation of testing methods will
be pre-requisite for the grant of registrations.
g) Pricing issues will be decided by the PRC.
h) The firms seeking manufacturing permission for minerals will be required
to possess the facility of the atomic absorption.
i) A committee comprising of two members each from PPMA & Pharma
Bureau along with MOH will scrutinize the pending applications in the
light of above recommendation in the light of Para b & c. This
committee would submit their recommendations for finalization of
formulations in line with b & c. They will also report about the food
supplements fate. A comprehensive report will be submitted for final
consideration of the Drugs Registration Board.
j) No new registration will be permitted to the Vitamins and Minerals
formulations which will not be identical with the formulations in b & c
or free sale certificate will be provided from the developed countries.
k) Single ingredient vitamin preparations shall be considered for registration
l) Pharmacopoeial standard vitamin preparations and vitamin products which
has expired patents shall also be considered for registration.
m) Only applications of firms having atomic absorption and flame photometer
shall be considered for registration.
Col. Muammad Aslam, honourable Member of the Board gave a comprehensive presentation
covering the scope, definition, classification etc to the Board and made certain
recommendations, which are as under:
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Vitamin
Lippincotts Biochemistry defines Vitamins as essential substances that the body usually takes
from outside sources. Generally this source is diet. In cases where intake from the diet is
insufficient, vitamin and mineral food supplements serve to supplement the daily diet.
1. Scope
1.1 This policy encompasses the regulations governing vitamins and mineral preparations in
the country. These vitamins, trace elements and mineral preparations collectively known
as micronutrients, are intended for the treatment of known deficiency to any of these
ingredients or the prophylaxis of deficiency in population prone to be deficient.
1.2 In general, the combination products of multivitamins and micronutrients will be

intended for prophylactic use, single vitamin preparations for treatment of deficiency and
B-complex as both prophylactic and treatment options.
1.3 The aim is to facilitate circulation of these products, to ensure a high level of protection
of public health and to provide a clear legal framework for manufacturers.
1.4 This policy on food supplements lays down provisions which:

1.4.1 regulate compositional aspects ( e.g positive lists of vitamins and minerals )
1.4.2 the chemical substances used as sources of vitamins and minerals in the
manufacture of food supplements should be safe and also be available to be used
by the body. for this reason, a positive list of those substances should also be
established.
1.4.3 provide for appropriate specific rules on labelling , presentation and advertising of
food supplements.
1.4.4 food supplements can contain a variety of ingredients, including, but not limited
to vitamins, minerals, amino acids, essential fatty acids, fibre and various plants
and herbal extracts.
1.4.5 as a first step the directive lays down specific provisions only for products
containing vitamins and minerals. Only vitamins and minerals listed in Annex I,
in the forms listed in Annex II, may be used for the manufacture of food
supplements. The units to be used for vitamins and minerals shall be those
specified in annex i.
1.5 The policy sets maximum and minimum levels for vitamins and minerals
1.5.1 the minimum level of each vitamin and/or mineral contained in a vitamin and
mineral food supplement per daily portion of consumption as suggested by the
manufacturer should be 15% of the recommended daily intake as determined by
FAO/WHO.
1.5.2 maximum amounts of vitamins and minerals in vitamin and mineral food
supplements per daily portion of consumption as recommended by the
manufacturer shall be set, taking the following criteria into account:
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Definitions:
2 Vitamin and mineral food supplements are sources in concentrated forms of those
nutrients alone or in combinations, marketed in forms such as capsules, tablets, powders,
solutions etc., that are designed to be taken in measured small unit quantities but are not
in a conventional food form and whose purpose is to supplement the intake of vitamins
and/or minerals from the normal diet.
3 Vitamin and mineral preparations can be divided into two categories

3.2.1 Food supplements: preparations containing vitamins and minerals at the level of
Recommended Dietary Allowance (RDA).
3.2.2 Therapeutic vitamins and minerals: preparations containing any of the vitamins
and minerals in quantities above the RDA quantities intended for therapeutic use
will be deemed as therapeutic class.
4 The vitamins and mineral preparations can be divided in to following categories;
4.2.1 multivitamins
4.2.2 micronutrients (vitamins + minerals + trace elements)
4.2.3 single vitamin preparations
4.2.4 vitamin b-complex
Multivitamins
5 Vitamins could be classified in to:

5.2.1 water-soluble vitamins: Thiamine (B1), Riboflavin (B2), Pantothenic Acid,
Niacin, Pyridoxine (B6), Folic Acid, Cobalamin (B12), Biotin, Choline And
Ascorbic Acid (C)
5.2.2 fat-soluble vitamins: Vitamin A (and its analog beta carotene), D, E, K
Trace elements
Electrolytes and minerals
Packaging:
5.2.3 The product shall be packed in containers which will safeguard the hygienic and
other qualities of the supplement.
5.2.4 The containers, including packaging material, shall be made only of substances
which are safe and suitable for their intended use.
Labelling & advertising
The labelling of therapeutic vitamins and minerals will follow the Drugs (Labelling and
Packing) Rules. The labelling of food supplements shall bear the following particulars in
addition to other customary conditions:
5.2.5 the names of the categories of nutrients or substances that characterize the product
5.2.6 the portion of the product recommended for daily consumption
5.2.7 a warning not to exceed the stated recommended daily dose
5.2.8 a statement to the effect that food supplements should not be used as a substitute
for a varied diet
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5.2.9 a statement to the effect that the products should be stored out of the reach of
young children
ANNEXURE-I
Vitamins & minerals which may be used in the manufacture of food supplements
Vitamins
1. Vitamin A (g re)
2. Vitamin D (g)
3. Vitamin E (mg -te)
4. Vitamin K (g)
5. Vitamin B1 (mg)
6. Vitamin B2 (mg)
7. Niacin (mg ne)
8. Pantothenic acid (mg)
9. Vitamin B6 (mg)
10. Folic acid (g)
11. Vitamin B12 (g)
12. Biotin (g)
13. Vitamin C (mg)
14. Calcium
15. Magnesium
16. Iron
17. Copper
18. Manganese
19. Sodium
20. Potassium
21. Selenium
22. Chromium
23. molybdenum
24. Fluoride
ANNEXURE-II
A. Vitamins
1. Vitamin A
i. Retinol
ii. Retinyl acetate
iii. Retinyl palmitate
iv. Beta-carotene
2. Vitamin D
i. Cholecalciferol
ii. Ergocalciferol
3. Vitamin E
i. D-alpha-tocopherol
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ii. Dl-alpha-tocopherol
iii. D-alpha-tocopheryl acetate
iv. Dl-alpha-tocopheryl acetate
v. D-alpha-tocopheryl acid succinate
4. Vitamin B6
i. Pyridoxine
ii. Pyridoxine hydrochloride
iii. Pyridoxine 5-phosphate
5. Folic acid
i. Pteroylmonoglutamic acid
6. Vitamin B12
i. Cyanocobalamin
ii. Hydroxocobalamin
7. Biotin
i. D-biotin
8. Vitamin C
i. L-ascorbic acid
ii. Sodium-l-ascorbate
iii. Calcium-l-ascorbate
iv. Potassium-l-ascorbate
v. L-ascorbyl 6-palmitate
B. Minerals
1. Calcium carbonate
2. Calcium chloride
3. Calcium salts of citric acid
4. Calcium gluconate
5. Calcium glycerophosphate
6. Calcium lactate
7. Calcium salts of orthophosphoric acid
8. Calcium hydroxide
9. Calcium oxide
10. Magnesium acetate
11. Magnesium carbonate
12. Magnesium chloride
13. Ferrous lactate
14. Ferrous sulphate
15. Ferric diphosphate (ferric pyrophosphate)
16. Ferric saccharate
17. Elemental iron (carbonyl+electrolytic+ hydrogen reduced)
18. Cupric carbonate
19. Cupric citrate
20. Cupric gluconate
21. Cupric sulphate
22. Copper lysine complex
23. Manganese chloride
24. Manganese citrate
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25. Manganese gluconate
26. Manganese glycerophosphate
27. Manganese sulphate
28. Sodium bicarbonate
29. Sodium carbonate
30. Sodium chloride
31. Sodium citrate
32. Potassium lactate
33. Potassium hydroxide
34. Potassium salts of orthophosphoric acid
35. Sodium selenate
36. Sodium hydrogen selenite
37. Sodium selenite
38. Chromium (iii) chloride
39. Chromium (iii) sulphate
40. Ammonium molybdate (molybdenum (vi))
41. Sodium molybdate (molybdenum (vi))
42. Potassium fluoride
43. Sodium fluoride
6 Internationally new guidelines make manufacturers of vitamins and dietary supplements
subject to some of the same review processes that other drug makers must undergo.
7 At times supplements contain ingredients that are either omitted from labeling or they
don't contain as much active ingredient as stated.
8. Recommendations
The Board unanimously agreed that following recommendations made the honourable member
provide comprehensive structure for the regulation of vitamins and mineral preparations/food
supplements:
1. All the preparations which contain vitamins more than the RDA (Recommended Daily
Allowance) should be classified as drugs. They should require registration under Drugs Act
1976.
2. The pharmaceutical companies having the atomic absorption equipment and facility for the
analysis of minerals and vitamins combination products should be given the registration of
such products.
3. Manufacturers or importers of vitamins, and other dietary supplements will have to test all of
their products' ingredients and notify the competent authority by forwarding it a model of the
label used for the product and a certificate regarding the presence of ingredients as claimed
on the label before bringing it in the market.
4. If the products do not contain the ingredients as per label, or products contain impurities or
unreported ingredients they shall be processed under the Drugs Act, 1976 for charges of
substandard, adulterated etc.
5. Food supplements would be purely meant for nutritional purpose and no claims will be made
about prevention, cure, diagnosis, mitigation or treatment of diseases.
6. Onus about safety will be on the manufacturers or importer of food supplements.
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7. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used
for the manufacture of food supplements. The units to be used for vitamins and minerals shall
be those specified in Annex-I.
8. Products that may be unsafe or make false or misleading claims are liable for such measures
that deem fit including inspections of dietary supplement manufacturers, importer, seller and
distributor.
9. The manufacturer or importer is responsible for ensuring that the supplements facts label and
ingredients list are accurate , the dietary ingredients are safe and the content matches the
amount declared on the label .
10. Only the license manufacturer can manufacture food supplements sections dedicated for food
supplements.
11. The prices of the food supplements would not be increased beyond limits. This would be
decided by the Price Advisory Committee as a principle guideline on the basis of units
mentioned in Annex-I.
12. Only food supplements from USA , UK , European Union , Canada and Japan would be
permitted for import in Pakistan.
13. Prior NOC and import license will be required for the import of food supplements.
14. The minimum level of each vitamin and/or mineral contained in a vitamin and mineral food
supplement per daily portion of consumption as suggested by the manufacturer should be
15% of the recommended daily intake.
15. Combination of vitamins with analgesic or antibiotics will not be allowed except
combination of pyridoxine with isoniazid or such combination that may benefit during a
course of treatment and is approved by the FDA, MHRA, TGA or the European Union.
16. High doses of vitamin that can increase the effect of blood-thinning medications well beyond
the desired result. Such preparations need to have a clear warning for patients on warfarin
17. The product shall be packed in containers which will safeguard the hygienic and other
qualities of the supplement.
18. The containers, including packaging material, shall be made only of substances which are
safe and suitable for their intended use.
19. The labelling of therapeutic vitamins and minerals will follow the Drugs (Labelling and
Packing) Rules. The labelling of food supplements shall bear the following particulars in
addition to other customary conditions:
i. the names of the categories of nutrients or substances that characterize the product
ii. the portion of the product recommended for daily consumption
iii. a warning not to exceed the stated recommended daily dose
iv. a statement to the effect that food supplements should not be used as a substitute for a
varied diet
v. a statement to the effect that the products should be stored out of the reach of young
children
vi. a statement to the effect that the products should be stored out of the reach of young
children.
vii. name and business place of the manufacturer
viii. complete list of the ingredients
ix. net content of each ingredient in the product
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x. technical additives and processing aids i.e. inactive ingredients may also be displayed
on the label.
xi. descriptive name of the product stating that it is a supplement
Food supplement manufacturers may claim that their products benefit the structure and
function of the human body or promote "general well-being" as long as each package includes
the disclaimer "this statement has not been evaluated by the Ministry of Health. This product is
not intended to diagnose, treat, cure, or prevent any disease." in effect, the vague product claims
and the blanket disclaimer separate the claims from the products.
The Board appreciated the comprehensive presentation by the honourable member which gives a
good structure for the regulation of vitamins and mineral preparations in Pakistan. It was also
apprised to the Board that food supplements does not come under the Monographs of the official
pharmacopoeias. The board deferred the matter till next meeting.
In the mean while a situation in case of Vivioptal Capsule of M/s. AGP arose when Additional
Collector of Customs passed an order claiming that Vivioptal is a Food Supplement and not a
medicine. They have held their consignment at air port and ordered to pay duty and sales tax of
food supplement i.e. 35% and 16% respectively. AGP claims that they have started receiving
complaints from market that product is short and people are suffering since the product is widely
prescribed by the doctors.
Decision: -
The board after discussion approved following policy.
PROPOSED RECOMMENDATIONS FOR MINISTRY OF HEALTH
1 Due to flood of unregistered vitamin products in the market under the garb of nutritional or
food supplements, there is a need for a definite policy regarding registration of vitamins or
vitamin with minerals
2 All the preparations would be classified as drugs. They should require registration under
Drugs Act 1976 by Ministry of Health
3 Vitamin and mineral preparations will be divided into two categories
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(a) Vitamin supplements: Preparations containing vitamins and minerals upto the level of
Recommended Dietary Allowance (RDA)
(b) Therapeutic vitamins and minerals: Preparations containing vitamins and minerals in
quantities above the RDA quantities intended for therapeutic use will be deemed as
therapeutic class.
4 The Board decided that the pharmaceutical companies which dont have Atomic
Absorption equipment for the analysis of minerals + vitamins combination products will be
granted registration of such products subject to analysis of minerals + vitamins from any
PNAC Accredited Laboratory. This permission will be valid for two years and during this
time firm will be bond to have this facility in its own pharmaceutical unit.
Moreover, all the Government (Provincial and Federal) drugs testing laboratories will equip
themselves for testing of these preparations. For this purpose Research and Development
Section will put proposal for strengthening of these Laboratories. The section will propose a
mechanism for outsourcing of testing / analysis of vitamins and minerals. R& D and QA
wings will also be consulted.
5 The registration of vitamin and mineral preparations are subject to price fixation by the
Price Advisory Committee.
6 Import of vitamin and mineral preparations will be allowed as per Import Policy for Drugs
of Ministry of Health.
7 The minimum level of each vitamin and / or mineral contained in a vitamin and mineral
supplement per daily portion of consumption as suggested by the manufacturer should be
atleast 15% of the recommended daily intake.
8 Combination of vitamins with analgesic or antibiotics will not be allowed except

combination of pyridoxine with isoniazid.
9 High doses of vitamin E can increase the effect of blood-thinning medications well beyond
the desired result. Such preparations need to have a clear warning for patients on warfarin.
10 Only vitamins and minerals listed in annex I, in the forms listed in annex II may be used for
the manufacture of vitamin supplements. The units to be used for vitamins and minerals
shall be those specified in annex I
11 Vitamin supplements would be purely meant for nutritional purpose and no claims will be
made about prevention, cure, diagnosis, mitigation or treatment of diseases
12 Vitamin supplement manufacturers may claim that their products benefit, the structure and
function of the human body or promote General well-being.
13 The CBR/customs will be informed that all imported vitamin supplement therapeutic
17
products treated as drugs.
The Board directed to present applications for registration of vitamins and mineral
preparations in forthcoming meeting of Registration Board for decision. However, the above
policy approved by Registration Board could not be finalizedin the following period.
Decision: Registration Board reviewed the case in light of decision of Lahore High
Court, Lahore. The Board was apprised that applications of M/s Friends Pharma, Lahore
were approved by Me-too committee of Registration Board in its 195th A meeting subject to
standard formulation. As per TORs of Me-too committee, this decision of Me-too
committee was to be ratified by Registration Board; however, in the subsequent meetings
of Registration Board and Me-too committee of Registration Board, it was decided to defer
all vitamin preparations till finalization of vitamin policy. As vitamins policy is pending till
to date, therefore, above decision of Me-too committee (195th A) could not be ratified by
Registration Board and hence could not be communicated to the firm.
It was discussed that as Health & OTC rules have been gazette notified by Drug
Regulatory Authority of Pakistan which covers nutritional supplements as well. The Board
discussed as now it is an overlapping area between pharmaceuticals and Health & OTC
products, thus the Board constituted a committee comprising of following for deliberation
on the matter and presentation of recommendation for consideration of Registration
Board.
Prof. Dr. Muzammil Hasan Najmi, Associate Dean, Basic Sciences Division, Foundation
Medical University, Rawalpindi Member Registration Board
Brig. Dr. Aslam Khan, Professor of Medicine, Military Hospital Rawalpindi Member
Registration Board.
Representatives of Health & OTC Division
Deputy Director General (R.I) Convener.
Meanwhile, honorable Lahore High Court, Lahore shall be informed of the steps
taken by Registration Board to decide applications of M/s Friends Pharma, Lahore.
Item No.IV: Approval of Clinical Trial effectiveness of Antibiotic prophylaxis during

surgical evacuation of the uterus for miscarriage management in low income countries: A
Multinational, Randomized, Double-Blind Placebo-Controlled Trial.
The subject trial is labeled as The AIMS (Antibiotics in Miscarriage Surgery) Trial is a MRC /
Welcome /DFID funded international trial organized by the University of Birmingham. The trial sites
apart from Pakistan are Malawi, Uganda and Tanzania. In Pakistan the trial will be conducted at Aga
Khan University Main Hospital, Hyderabad Hospital and Karimabad Hospital.
The principal objective of the trial is to test the hypothesis that in women having miscarriage surgery,
pre-surgery prophylactic antibiotics (oral Doxycycline 400 mg and Metronidazole 400 mg) reduces the
risk of pelvic infection within 14 days of surgery.
The outcome of the trial will be:
18
Primary outcome: Pelvic infection within 14 days of surgery, defined as two or more of
a) purulent vaginal discharge, b) pyrexia >38.0 C, c) uterine tenderness on examination
and d) a white cell count > 15 x 109 / l, with no other recognized cause of infection.
Secondary outcomes: Death, hospital admission, unplanned consultations, antibiotic use
for presumed diagnosis of pelvic infection, blood transfusion, vomiting, diarrhea, adverse
events, anaphylaxis and allergy, duration of clinical symptoms (pain, additional
analgesia, vaginal bleeding, days before return to usual daily activities).
The trial was sent to three experts for their expert opinions. The comments received are placed
below:
S# Name of Experts Comments of Experts

1 Dr. Naila Israr The antibiotics mentioned in the trial are
Consultant Gynecologist already being used in Pakistan for different
indication. I suggest that trial can be done in
Pakistan with submitted protocol for public
interest.
2 Co. Abeera Chaudhary I Completely agree with the justification of
Gynecologist the much needed AIMS Trial considering
the burden of disease and lack of robust
evidence regarding justification of
antibiotics in surgery for miscarriage, it is a
much needed trial and should be pursued
expeditiously.
3 Dr. Syeda Batool Prof / Head of Comments awaited
Department of Gynecology
The said trial has been cleared by the Research Ethics Committee of National Bioethics
Committee Aga Khan Hospital.
The case is placed before the Registration Board for consideration / approval of the
clinical trial and permission to import Doxycycline 400 mg, Metronidazole 400 mg and placebo
tablets.
Decision: Registration Board approved the above clinical trial.
19
Item No.V: Registration of drugs (cases referred by Pharmaceutical Evaluation cell).
Case No.01. Registration of Sofosbuvir containing medicines.
Sovaldi (Sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor
indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination
antiviral treatment regimen. The Secretary, Ministry of National Health Services, Regulations and
Coordination, considering the plea of the Managing Director of M/s Ferozesons for priority registration of
the drug in Pakistan and in the meanwhile allowing its import for 500 patients personal use, keeping in
view the public health needs and public interest, was pleased to direct the Registration Board that:
The registration applications for the drug (Sofosbuvir / Sovaldi) be processed

and considered by the Registration Board on priority in its next meeting.
Accordingly, the registration applications of Sofosbuvir, received by the Pharmaceutical

Evaluation Cell, have been processed / evaluated on priority basis and placed before the Board for
consideration.
Total duration of treatment depends upon the genotype of the virus causing Hepatitis C. As per
FDA approved label, 400 mg tablet be taken once daily with or without food and should be used in
combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of
chronic Hepatitis C.
HCV Mono-infected
and HCV/HIV-1 Co-
infected Treatment Duration
SOVALDI + peg-interferon
Genotype 1 or 4 12 weeks
alfa + ribavirin
Genotype 2 SOVALDI + ribavirin 12 weeks
Genotype 3 SOVALDI + ribavirin 24 weeks
One such application with name of Sofovir 400 mg Tablet applied by M/s Wenovo
Pharmaceuticals Taxila, had been placed in the previous Board meeting M-243, which was deferred on
the following grounds, may also be considered in the light of above direction of the Honourable
Secretary, Ministry of National Health Services, Regulations and Coordination:
a) Expert opinion by:

i. Dr. Najam, Shifa International
ii. Dr.Tassawar, Fauji Foundation
iii. Dr. Pervaiz
20
b) Product specific inspection by:
i. Dr. Muzammal Hassan Najmi
ii. Director QA & Lab Testing
iii. Area FID
c) Source of API
Various manufacturers applied for local manufacturing of the drug. 17 applications have been evaluated
and applicants have been informed about shortcomingstions. Rest of applications are in phase of
evaluation and evaluation report will be forwarded to applicants accordingly.
Evaluator II
S/N Name and Brand Name Type of Form Remarks on the formulation (if any) including
address of (Proprietary Initial date, International status in stringent drug regulatory
manufacturer / name + Dosage diary agencies / authorities
Applicant Form + Strength) Fee including Me-too status
Composition differential GMP status as depicted in latest inspection report
Pharmacological fee (with date) by the Evaluator
Group Demanded
Finished product Price / Pack
Specification size
1. M/s Atco Buvir 400mg Form 5-D FDA: Sovaldi (Gilead Sciences Inc)
Laboratories Tablets
Limited, B-18, Each Film Coated 29-04-2014 New application
S.I.T.E., Karachi. Tablet contains:- (529)
Sofosbuvir Satisfactory GMP. (27-12-2013)
Rs.50,000/
(M.S).400mg
(Anti-Viral)
(Manufacturers Rs. 2500.00/- 1. Signatures are required to be verified whether they
Spec.s) Per Tablet have been done by relevant persons (List of signatures
Pack size: 7s, identification by Chief executive of the firm).
14s, 28s 2. SOPs / procedure to record and inform about the
change of person are required.
3. Master formulation with scientific names as present in
the relevant pharmacopoeia and quantities of all the
ingredients including excipients, Batch size,
Quantities to be used per Batch, Source of active and
inactive starting materials, Role of inactive starting
materials and the Justification of their quantities used
is required.
4. Reference of Specifications of Finished product is
required.
5. Details of Reference standard (Primary or Secondary)
being used are required.
6. List of specific equipments / instruments required for
tests of applied drug (e.g., Atomic Absorption
Spectrophotometer is required for analysis of
21
minerals) is required.
7. Undertaking of submitting before marketing of the
product, Description of Suitability of container
closure system comprising of parameters(i) Protection
of Drug(ii) Compatibility of Drug(iii) Safety of Drug
&(iv) Performance of Drug (Stability studies will
establish the the final suitability of container closure
system) is required.
8. CD of the dossier alongwith Undertaking that the CD
contains the same information / data as submitted by
the applicant in the dossier and that the CD is in
operative condition is required.
9. Before marketing of the product an undertaking that
the firm shall submit the clinical trial data is required.
2. M/s CCL Sofos 400mg Form 5-D FDA: Sovaldi (Gilead Sciences Inc)
Pharmaceuticals Tablets
(Pvt.) Ltd. 62- Each Film Coated 04-07-2014 New application
Industrial Estate, Tablet contains:- (1173)
Sofosbuvir
Kot Lakhpat, Rs.50,000/ Good GMP. (18-12-2013)
.400mg
Lahore. (Anti-Viral)
(Manufacturers As per brand 1. Signatures are required to be verified whether
Spec.s) leader/ they have been done by relevant persons (List of
28s
signatures identification by Chief executive of
the firm).
2. SOPs / procedure to record and inform about the
change of person are required.
3. Certificate of Analysis of active raw material is
required.
4. Reference of specfications of active starting
material(s) i.e., API (Active Pharmaceutical
Ingredient) is required.
5. Reference of Specifications of finished product is
required.
6. Details of Reference standard (Primary or
Secondary) being used are required.
7. Undertaking of submitting before marketing of
the product, Description of Suitability of
container closure system comprising of
parameters(i) Protection of Drug(ii)
Compatibility of Drug(iii) Safety of Drug &(iv)
Performance of Drug (Stability studies will
establish the the final suitability of container
closure system) is required.
8. Undertaking that the CD contains the same
information / data as submitted by the applicant
22
in the dossier and that the CD is in operative
condition is required.
9. Before marketing of the product an undertaking
that the firm shall submit the clinical trial data is
required.
3. M/s Cirin Sovir 400mg Form 5-D FDA: Sovaldi (Gilead Sciences Inc)
Pharmacuticals Tablets
Pvt. Ltd 32/2-A, Each Film Coated 12-03-2014 New application
Phase-III, Tablet contains:- (855)
Sofosbuvir
Industrial Estate Rs.50,000/ Good GMP. (01-10-2013)
.400mg
Hattar District (Nucleotide analog
Haripur, Khyber inhibitor of HCV) Not mentioned/ 1. Signatures are required to be verified whether
Pakhtunkhwa. (Manufacturers 47s, they have been done by relevant persons (List of
Spec.s) 28s
the firm).
2. Attested Copy of DML / Renewal of DML (In
case of more than 5 years) is required.
3. Evidence of approval of section / manufacturing
facility of applied drug from licensing section is
required.
4. An undertaking/commitment (on prescribed
format) as per decision of Registration Board
regarding the submission of (a) Stability studies
(b) Pharmaceutical Development Studies(c)
Validation of analytical testing methods studies
(d) Process validation (e) Label claims and
prescribing information being same as approved
by reference drug agencies e.g., FDA, TGA,
MHLW, EMA and Health Canada is required.
5. Proposed Price of product not provided.
6. Evidence of approval of production in-charge
from licensing section is required.
7. Reference of Specfications of active starting
material(s) i.e., API (Active Pharmaceutical
Ingredient) is required.
8. Reference of Specifications of finished product is
required.
10. Evidence of approval of the persons working in
quality control from Licensing section is
23
required.
12. Undertaking that the CD contains the same
information / data as submitted by the applicant
in the dossier and that the CD is in operative
condition is required.
required.
4. M/s PharmEvo Sofvir 400mg Form 5-D FDA: Sovaldi (Gilead Sciences Inc)
(Pvt.) Limited Tablets
Plot#A-29, North Each Film Coated 14-07-2014 New application
West Industrial Tablet contains:- (1414)
Sofosbuvir
Zone, Port Qasim, Rs.50,000/ Good GMP. (20-03-2013)
.400mg
Karachi-75020 (Anti-Hepatitis C)
(Manufacturers As per PRC 1. Signatures are required to be verified whether
Spec.s) they have been done by relevant persons (List of
the firm).
2. Attested Copy of DML / Renewal of DML (In
case of more than 5 years) is required.
4. Complete and updated Specfications of active
starting material(s) i.e., API (Active
Pharmaceutical Ingredient) with reference are
required.
5. Certificate of Analysis of API is required.
6. Reference of Specifications finished product is
required.
required.
9. GMP report is not latest (should be conducted
with in six months from the date of evaluation of
24
dossier and having detailed assessment of facility
in which the applied drug will be manufactured
whether it is GMP compliant or not.)
10. Types of container / packaging not provided.
11. Complete Specifications(Physical & Chemical
Characteristics) of the container closure system
(Primary Packaging, Secodary Packaging &
Associated components e.g., caliberated spoon
etc.) fulfilling the compendial requirement are
required.
13. CD of the dossier alongwith Undertaking that the
CD contains the same information / data as
submitted by the applicant in the dossier and that
the CD is in operative condition is required.
required.
15. Undertaking that in case of resemblance of brand
name and packaging of applied product, the firm
will change these; is required.
5. M/s Global Viro-C 400mg Form 5-D FDA: Sovaldi (Gilead Sciences Inc)
Pvt, Ltd Plot#204- Each Film Coated 15-07-2014 New application
205, Industrial Tablet contains:- (122-PEC)
Sofosbuvir
Triangle, Kahuta .400mg
Rs.50,000/ Good GMP. (26-02-2013)
Road, Islamabad. (Antiviral agent)
(Manufacturers As per SRO 1. Each page not signed (original) by authorized /
Spec.s) approved production and Quality Control
Incharge.
2. Signatures are required to be verified whether
they have been done by relevant persons (List of
the firm).
3. Source with Certificate of Analysis of API is
required.
4. Stepwise details of manufacturing process
25
including Precautions/Control required to
produce specified quantities of the drug applied
for registration and demonstration of cleaning
validation procedures, Identification &
description of Critical steps which may alter the
results and tests for IPQC including weight
variation, hardness, friability, water content, etc
are required.
6. List of particular equipments (used for
production of applied product) showing its model
and capacities along with their status of cGMP
compliance is required.
7. Complete and updated Specfications of active
starting material(s) i.e., API (Active
Pharmaceutical Ingredient) with reference are
required.
8. Complete and updated Specfications of inactive
materials/excipients with reference are required.
9. Reference of and complete Specifications of
finished product are required.
required.
12. GMP report is not latest (should be conducted
with in six months from the date of evaluation of
dossier and having detailed assessment of facility
in which the applied drug will be manufactured
whether it is GMP compliant or not.)
13. Types of container / packaging not provided.
14. Complete Specifications(Physical & Chemical
Characteristics) of the container closure system
(Primary Packaging, Secodary Packaging &
Associated components e.g., caliberated spoon
etc.) fulfilling the compendial requirement are
required.
26
16. CD of the dossier alongwith Undertaking that the
CD contains the same information / data as
submitted by the applicant in the dossier and that
the CD is in operative condition is required.
required.
Evaluator III
S/N Name and Brand Name Type of Form Remarks on the formulation (if any) including
address of (Proprietary name + International status in stri ngent drug
manufacturer / Dosage Form + Initial date, diary regulatory agencies / authorities
Applicant Strength)
Fee including Me-too status
Composition differential fee
GMP status as depicted in latest inspection report
Pharmacological Group Demanded Price / (with date) by the Evaluator
Pack size
Finished product
Specification
6. M/s Tabros Vibrenta Tablet 400mg Form-5D a. An undertaking / commitment as per descion
Pharma (Pvt) of 241st meeting of Registration Board of
Limited, L-20/ B, Each film coated tablet Dated: 07/07/14 Dy DRAP to submit data of the following before
F.B. Industrial contain No: 11 marketing of drug product.
Area, Karachi Sofosbuvir.400mg
20,000/-
Anti-viral i. Stability studies
Rs: 8200/- per ii. Process validation
Manufacturer tablet/ pack of iii. Pharmaceutical development
1x14s, 2x 14s iv. Validation of analytical method.
b. An undertaking to submit Patient information

leaflet (PIL), Summary of poduct
characteristics (SmPC) and prescribing
information as per approved by drug
regulatory agencies or authorities of FDA,
EMA, TGA, Health Canada and MHLW
c. Copy of fee deposit slip of Rs.20,000/- is
submitted. Original deposit slip is required.
Moreover differential fee needs to be
submitted as per rules for application on Form-
5D
d. Attested copy of DML/ renewal in case of
27
more than five years.
e. Evidence of approval of section.
f. An undertaking to change the brand name in
case of resemblance with the already registered
brands.
g. Role of inactives needs to be submitted.
h. Complete specifications of active raw material
needs to be submitted along with the source
and certificate of analysis.
i. Clinical data (along with dat of clinical trials
conducted and safety data of drug, with reorted
side effect and adverse drug reactions in
indigenous community.
Inspection of the firm was conducted on 11-

03-14 by the area FID and GMP compliance is
rated as GOOD.
7. M/s Genome CHC-400 Tablets Form-5 a. Application of Form-5D and diffrentiel fee
Pharmaceuticals, under the rules is required as product is not yet
(Pvt) Limited, Each film coated tablet Dated:25/06/14 registered with DRAP.
Plot No 16/I, contains Dy No: 280 b. Attested copy of DML/ renewal in case of more
Phase IV, Sofosbuvir400mg
than five years.
Industrial Estate, Rs: 20,000/-
Hattar. Anti-viral (NS5B RNA c. Evidence of approval of section.
Polymerase Inhibitor) As per SRO d. An undertaking to change the brand name in
case of resemblance with the already registered
Manufacturer brands.
e. Identification of API by IR spectrophotometery
is submitted. Evidence of availability of FTIR is
required.
f. Clinical data (along with dat of clinical trials
Inspection of the firm was conducted on 27-12-

13 by the panel of inspectors and recommended
the grant of GMP for export purpose
8. M/s Helix Pharma Sofovir Tablets 400mg Form-5D a. Attested copy of DML/ renewal in case of
(Pvt) Limited, more than five years.
Hakimsons Each film coated tablet Dated:26/03/14 b. Evidence of approval of section.
House, A/56, contains Dy No: 138-R-II c. An undertaking to change the brand name in
S.I.T.E. Sofosbuvir..400mg
Manghopir Road, Rs: 50,000/-
case of resemblance with the already
Karachi Direct Acting Anti-viral registered brands.
As per PRC/ Pack d. An undertaking to submit Patient information
Manufacturer of 10s, 20,s and leaflet (PIL), Summary of poduct
30,s characteristics (SmPC) and prescribing
information as per approved by drug
regulatory agencies or authorities of FDA,
EMA, TGA, Health Canada and MHLW
e. Incomplete stability data is submitted. Stability
protocol, description of container closure
28
system, details of batch studied like batch size,
batch no, batch results (Appearance, odour,
drug substance content, degradation products,
dissolution kinetics, hardness, water content
etc) date of manufacturing, date of start of
study, certificate of analysis of API and
proof of purchase of raw material is required
otherwise submit an undertaking as per
decision of Registration Board to submit the
data of following before marketing the drug
product:-
i. Stability studies
ii. Process validation
iii. Pharmaceutical development
iv. Validation of analytical method
f. Specifications of API are required.

g. Clinical data (along with data of clinical trials
Inspection of the firm was conducted on 27-02-14

by area FID and GMP compliance is rated as
SATISFACTORY.
9. M/s Martin Dow Osvir Tablets 400mg Form-5D a. An undertaking to change the brand name in
Limited, Plot No case of resemblance with the already registered
37, Sector 19, Each film coated tablet Dated:15/07/2014 brands.
Korangi Industrial contains Dy No: 1561 b. Clinical data (along with data of clinical trials
Area, Karachi. sofosbuvir..400mg
conducted and safety data of drug), with
Rs: 50,000/-
Direct acting antiviral reported side effect and adverse drug reactions
agents As per PRC/ Pack in indigenous community.
of 7s,and 10s c. Certificate of analysis of API is required.
Manufacturer
Inspection of the firm was conducted on 08-
01-14 by the area FID and GMP compliance is
rated as GOOD.
10. M/s Wenovo Sofovir 400 mg Form 5D Decision of Registration Board in M-244
Taxila, Each Film Coated Tablet Dated 07-03-2014 a) Expert opinion by:
contains:- Dy No. 932 i. Dr. Najam, Shifa
Sofosbuvir .400mg
International
(Anti-Viral) Rs: 50,000/-
(Manufacturers Spec.s) ii. Dr.Tassawar, Fauji
Rs.85,000/- per Foundation
Tablet iii. Dr. Pervaiz
Pack of 10s b) Product specific inspection by:
i. Dr. Muzammal
Hassan Najmi
ii. Director QA & Lab
29
Testing
iii. Area FID
c) Source of API
30
Evaluator IV
S/ Name and Brand Name Type of Form Remarks on the formulation (if any) including
N address of (Proprietary name + International status in stringent drug
manufacturer/ Dosage Form + Initial date, diary regulatory agencies / authorities
Applicant Strength)
Fee including Me-too status
Composition differential fee
GMP status as depicted in latest inspection
Pharmacological Demanded Price / report (with date) by the Evaluator
Group Pack size
Finished product
Specification
11. M/s Ferozsons Sovaldi Tablet 400 Form 5 D International: Sovaldi Tablet 400 mg (FDA)
Laboratories mg 08-05-2014 Local: New drug
Limited Each film coated Rs 50,000 Reply of evaluation report is awaited
P.O. Ferozsons tablet contains MRP Rs 55,000/ GMP of manufacturer M/s Patheon Inc., Canada
Amangarh- Sofosbuvir400 bottle of 28 tablets has been submitted
Nowshera. mg a. On Certificate of pharmaceutical Product
Pakistan (COPP) of US-FDA, it is mentioned that
Manufactured (Antiviral) Product is not on market in exporting
by: Finished product country (USA)
M/s Patheon Inc., specifications are The FDA has no specific knowledge of
2100 Syntex Manufacturer. cGMP of this foreign manufactured
Court, product for the current cGMP status
Mississauga, contact country of manufacturer. This
Ontario, L5N certificate pertains to product marketed
7K9, Canada. in United States.
Manufactured This product is approved, but is not
for: currently marketed in United States.
Product license This product is not currently listed with
Holder FDA.
Gilead Sciences b. Any agreement between M/s Gilead and M/s
inc., Patheon for manufacturing of product is
333 Lakeside required.
Drive, Foster c. Firm has mentioned Ireland as site for
City, CA, 94404, packaging and warehousing. At annex 6 of
USA. dossier importing country is again mentioned as
Ireland. Clarification is required about this point.
d. Process validation data has not been
provided.
e. Undertaking for clinical trial in indigenous
population is required.
f. In validation of analytical method,
chromatograms of sample have 31 not been
attached.
g. In stability studies data, chromatograms of
sample and reference have not been attached.
Just summary of studies have been provided.
Complete studies on full three batches are
required.
h. For Studies like provide process validation,
stability studies, pharmaceutical development
studies & validation of analytical methods, an
undertaking may be submitted regarding the
provision of the same before marketing of said
product.
i. Firm has not mentioned source and
specifications of active raw material.
12. M/s Macter Sofomac Tablets 400 Form 5 D International: Sovaldi Tablet 400 mg (FDA)
International mg 17-03-2014 Local: New drug
Limited. Each film coated 50,000 Reply of evaluation report is awaited
F-216, S.I.T.E., tablet contains Rs. 8000/ tablet According to report of inspection conducted on
Karachi. Sofosbuvir Rs. 112,000/ 14s 10-13 June, 2013, firm is considered to be
MS..400 mg complying with GMP guidelines.
Rs. 224,000/ 28s a. Batch size and quantities to be used per
(Nucleotide Analog batch have not been mentioned.
NS5B Polymerase b. Details regarding source of active raw
Inhibitor) material has not been provided in dossier.
c. Method of manufacturing is incomplete,
general and without mentioning critical
steps, precautions and in process controls.
d. Firm has not provided analytical details of
active raw material and finished product.
e. Firm has not given QC tests for tablets as
tests of hardness, thickness, friability,
disintegration, dissolution, diameter, weight
variation etc.
f. Details of reference standards have not been
provided.
g. For Studies like provide process validation,
stability studies, pharmaceutical
development studies & validation of
analytical methods, an undertaking may be
submitted regarding the provision of the
same before marketing of said product.
h. For Summary of Product Characteristics
(SmPC), Patient information leaflet (PIL)
Prescribing Information (PI), you may
submit an undertaking that said information
would be same as approved by reference
drug agencies like FDA, TGA, MHLW,
EMA and Health Canada.
13. M/s Getz Pharma Sofiget Tablets 400 Form 5 D International: Sovaldi Tablet 400 mg (FDA)
(Private) limited. mg 30-06-2014 Firm has mentioned source of raw material as
29-30/27, Each film coated 50,000 M/s Shanghai Desano Pharmaceuticals
Korangi tablet contains Unit pack size: 28 Investment Co., Ltd China.
Industrial Area, Sofosbuvir tablets Firm gave in house (China manufacturer)
Karachi. MS..400 mg Proposed/ specification of raw material and in house (Getz)
32
Demanded MRP Rs specifications of finished product
(Nucleotide Analog 140,000/- Local: New drug
NS5B Polymerase Rs 5,000/ tablet According to report of inspection conducted on
Inhibitor) 28-04-2014, firm is considered to be operating at
Finished product very good level of compliance with cGMP
specifications are guidelines.
Manufacturer.
Evaluator- V
Sr. Name and Brand Name (Proprietary Type of Form Remarks on the formulation
No. address of name + Dosage form + (if any) including
Manufacturer / Strength) Initial date, diary International status in
Applicant stringent regulatory agencies /
Composition Fee including authorities
differential fee
Pharmacological Group Me-too status
Demanded Price /
Finished product Pack size GMP status as depicted in
specification inspection report (dated)
14. M/s Hilton Pharma Sofohil Tablets Form 5D An undertaking regarding the
(Pvt) Ltd., 13, submission of stability studies
Sector 15, Korangi Film coated tablets 31/03/2014 has been provided along with
Industrial Area, 343 R&I clinical trial data of SOVALDI.
Karachi Each film coated tablet
contains: SOVALDI
31/03/2014 400mg f/c tablet
Sofosbuvir . 400mg (Rs. 50,000/-) US FDA
Antiviral
As per PRC
Manufacturers specifications GMP compliance rated as good
28s Rs. 50,000/- per dated 20/06/2013
Source of API: Wuxi Sigma tablet
Chemical Co., Ltd.
15. M/s Genix Sofo Tablets Form 5D An undertaking regarding the

Pharmaceuticals submission of stability studies
(Pvt) Ltd., 44- Film coated tablets 16/06/2014 has been provided along with
45/B, Korangi 500 R-II clinical trial data of SOVALDI.
Industrial Area, Each film coated tablet
Karachi contains: 16/06/2014 SOVALDI
(Rs. 50,000/-) 400mg f/c tablet
Sofosbuvir . 400mg Duplicate challan along US FDA
with original company
Antihepatitis / Antiviral / firm copy provided GMP compliance considered to
As per PRC be good dated 18/12/2013
33
Manufacturers specifications 14s = 952,000/-
28s = 1,904,000/-
Source of API: Hangzhou
Rongda Pharm & Chem Co., Rs. 68,000/- per tablet
Ltd.
16. M/s Everest Sovir Tablets Form-5 a. Evidence of renewal of

Pharmaceuticals, DML
124, Industrial Each film coated tablet Dy No 1021 dated 27- b. Evidence of approval of
contain 06-2014 technical staff from
Triangle, Kahuta,
Sofosbuvir400mg Licensing
Road Islamabad.
50,000/- c. Submitted application is on
Antiviral Drug form 5, so needs to be
Rs.398 per tablet submitted on Form 5-D.
Manufacturer Rs.3980/- Pack of 10s d. Methylene chloride is used
Rs.11940/- Pack of as solvent in film coating
30s under coating formulation
which is class II solvent as
per ICH guidelines and its
use has been limited due to
its inherent toxicity. You
are advised to revise the
master formulation and
submit the same with
quantities of all the
ingredients including
excipients, batch size,
quantities to be used per
batch and the justification
(safe limits with reference
etc,) of their quantities used.
e. Stepwise details of
manufacturing process
including
precautions/controls and
relevant SOPs required to
produce specified quantities
of the drug applied for
registration.
f. Specifications of API along
with Source & certificate of
analysis.
g. Method of determination of
water content along with the
availability of Karl Fischer
Titrator or other equipment
for the purpose is required
under finished product
specification.
h. Complete dissolution
34
testing method with details
of dissolution medium,
RPM speed etc. along with
the acceptance criteria is
required.
i. Evidence of purchase of
API and reference standard
(Sofosbuvir GS 7977) along
with its qualification /
validation / calibration is
required as firm has
submitted the UV-spectrum
and chromatograms
(without calculation) of
sample and standard
solution (which does not
look to be original) under
identification and assay
method.
j. Assay method under
finished product
specifications is ambiguous/
incomplete, details of
mobile phase of HPLC are
not provided. Moreover,
under equipment details
variable wavelength UV
detector is mentioned and
under chromatographic
conditions photodiode array
(PDA) detector is
mentioned. This needs
clarification.
k. Patient information leaflet
(PIL), Summary of poduct
characteristics (SmPC) and
prescribing information as
per approved by drug
regulatory agencies or
authorities of FDA, EMA,
TGA, Health Canada and
MHLW is
required.However the
submitted iformation is of
brand leader
l. Clinical data (along with
data of clinical trials
conducted and safety data
of drug, with reoprted side
effect and adverse drug
reactions in indigenous
35
community along with
clinacal justification as per
requiremnet of Form-5D.
m. Stability studies, process
validation, pharmaceitical
development studies and
validation of analytical
method data is not
submitted. However you
may submit an undertaking
to submit data of the same
before marketing of drug
product for consideration of
Registration Board.
n. Complete details of HVAC
under which the applied
drug will be
manufactured.Attach data
for the following
parameters: Particulate
matter (Mention the class of
area (A, B, C, D or class
100, 10 000, 100 000).
,humidity,temperature, air
velocity/ volume and air
pressure.
o. Specifications of water used
during manufacturing of
applied product, source
along with process of water
treatment along with source
needs to be submitted.
p. Packaging material/
container closure
specifications are not
submitted.
q. Suitability of container
closure system has not been
provided. An undertaking of
submitting description of
suitability of container closure
system comprising of
following
parameters:Protection of Drug,
Compatibility of Drug, Safety
of Drug& Performance of
drug.
r. Evidence of approval of
section from licensing section
is not provided.
s. Last / latest inspection
report that should be
36
conducted with in six
months from the date of
evaluation of dossier and
having detailed assessment
of facility in which the
applied drug will be
manufactured whether it is
GMP compliant or not.
Incharge, Pharmaceutical Evaluation Cell informed that following applications of Sofosbuvir have also been
evaluated in light of check list approved by Registration Board and shortcomings have been communicated to
applicants.
Evaluator-I
17. M/s Akson Heposbuvir 400mg Form 5-D FDA: Sovaldi (Gilead Sciences
Pharmaceuticals Tablets Inc)
(Pvt) Ltd. Each Film Coated Tablet 18-07-2014 (518)
contains:- Rs.50,000/ New application
Plot No. 9-B/1&2, Sofosbuvir (M.S).400mg
(Anti-Viral) As per SRO Satisfactory GMP. (14-05-2013)
Sector D-1, Old
(Manufacturers Spec.s) Pack size: a. Signatures are required
Industrial Estate,
1 x10s, to be verified whether
Mirpur, Azad they have been done by
Kashmir, relevant persons (List of
signatures identification
by Chief executive of
the firm).
b. SOPs / procedure to
record and inform about
the change of person are
required.
c. Reference of
Specifications of
Finished product is
required.
d. Details of Reference
standard (Primary or
Secondary) being used
are required.
e. List of specific
equipments /
instruments required for
37
tests of applied drug
(e.g., Atomic
Absorption
Spectrophotometer is
required for analysis of
minerals/heavy metals)
is required.
f. Stepwise details of
including
relevant SOPs required
to produce specified
quantities of the drug
applied for registration.
g. Specifications of API
along with Source,
certificate of analysis &
proof that in the
exporting country it is
registered for used on
humans & not on
clinical trial are
required.
h. Identification of API by
IR spectrophotometery
is submitted. Evidence
of availability of FTIR
is requiredas it is not
mentioned in equipment
list.
i. Proposed Price of
product not provided.
j. Complete dissolution
testing method with
details of dissolution
medium, RPM speed
etc. along with the
acceptance criteria is
required.
38
k. Assay method under
finished product
specifications is
ambiguous/ incomplete.
Moreover, under
equipment details
phenyl column is
mentioned and type of
HPLC (gradient or
isocratic along with
type of detector is not
mentioned). This needs
clarification.
l. Patient information
leaflet (PIL), Summary
of poduct characteristics
(SmPC) and prescribing
information as per
approved by drug
authorities of FDA,
EMA, TGA, Health
Canada and MHLW is
submitted information
is of brand leader.
m. Clinical data (along

with data of clinical
trials conducted and
safety data of drug, with
reoprted side effect and
adverse drug reactions
in indigenous
clinacal justification as
per requiremnet of
Form-5D.
n. You have submitted that

raw material of
sofosbuvir is stored at
0-4C for short term (for
days to weeks) and or -
39
20C for long term
(months to years) which
requires confirmation of
storage conditions for
transportation,
manufacturing etc at
this low temperature.
o. Stability studies,
process validation,
pharmaceutical
development studies
and validation of
analytical method data
is not submitted.
However you may
submit an undertaking
to submit data of the
same before marketing
of drug product for
consideration of
Registration Board.
p. Complete details of
HVAC under which the
manufactured.Attach
data for the following
matter (Mention the
class of area (A, B, C, D
or class 100, 10 000,
100 000).
,humidity,temperature,
air velocity/ volume and
air pressure.
q. Specifications of water
used during
manufacturing of
along with process of
water treatment along
with source needs to be
40
submitted.
r. Packaging material/
container closure
submitted.
s. Suitability of container
closure system has not
been
provided.Undertaking
of submitting before
marketing of the
product, Description of
Suitability of container
closure system
comprising of
parameters(i) Protection
of Drug(ii)
Compatibility of
Drug(iii) Safety of Drug
&(iv) Performance of
Drug (Stability studies
will establish the the
final suitability of
container closure
t. Evidence of approval of
section from licensing
section is not provided.
u. Last / latest inspection

v. CD of the dossier alongwith

Undertaking that the CD
contains the same
41
information / data
assubmitted by the applicant
in the dossier and that the
CD is in operative condition
is required.
w. Before marketing of the

product an undertaking that
the firm shall submit the
clinical trial data is
required.
18. -do- Liversof 400mg/90mg Form 5-D New application

Tablets
Each Film Coated Tablet 18-07-2014 (519) Satisfactory GMP. (14-05-2013)
contains:- Rs.50,000/
Sofosbuvir (M.S).400mg a.Signatures are required to be
Ledipasvir As per SRO
verified whether they have been
(M.S).90mg Pack size:
done by relevant persons (List
(Anti-Viral) 1 x10s,
of signatures identification by
(Manufacturers Spec.s) Chief executive of the firm).
b. SOPs / procedure to record

and inform about the change of
person are required.
c. Reference of Specifications of
Finished product is required.
d. Evidence of international
approval/registration in
reference countries like FDA,
EMA, TGA, Health Canada etc
along with date of approval are
not provided.
e. Details of Reference standard

(Primary or Secondary) being
used are required.
f. List of specific equipments /

instruments required for tests of
applied drug (e.g., Atomic
Absorption Spectrophotometer
42
is required for analysis of
minerals/heavy metals) is
required.
g. Stepwise details of
including precautions/controls
and relevant SOPs required to
produce specified quantities of
the drug applied for registration.
h. Specifications of API
(incomplete and ambiguous)
along with Source, certificate of
analysis & proof that in the
exporting country it is registered
for used on humans & not on
clinical trial are required.
i. You have submitted that raw

material of Ledipasvir is present
as Ledipasvir acetone solvate
which is removed during
manufacturing process, it
requires justification and also
not mentioned in manufacturing
process.
f. Identification of API by IR
spectrophotometery is
submitted. Evidence of
availability of FTIR is
requiredas it is not mentioned in
equipment list.
g. You have submitted that raw

material of Ledipasvirand
sofosbuvir are stored at 0-4C
for short term (for days to
weeks) and or -20 C for long
term (months to years) which
requires confirmation of storage
conditions for transportation,
manufacturing etc at this low
temperature.
43
h. Proposed Price of product not
provided.
i. Complete dissolution testing

method with details of
dissolution medium, RPM speed
etc. along with the acceptance
criteria is required.
j. Assay method under finished

product specifications is
ambiguous/ incomplete.
Moreover, under equipment
details phenyl column is
mentioned and type of HPLC
(gradient or isocratic along with
type of detector is not
clarification.

prescribing information as per
approved by drug regulatory
agencies or authorities of FDA,
EMA, TGA, Health Canada and
MHLW is required.However the
submitted informations are
without reference.
l. Clinical data (along with data

of clinical trials conducted and
reoprted side effect and adverse
drug reactions in indigenous
community along with clinacal
justification as per requiremnet
of Form-5D.

validation, pharmaceutical
validation of analytical method
data is not submitted. However
you may submit an undertaking
44
Registration Board.

under which the applied drug
will be manufactured.Attach
parameters: Particulate matter
(Mention the class of area (A,
B, C, D or class 100, 10 000,
100000). ,humidity,temperature,
air velocity/ volume and air
pressure.

during manufacturing of applied
product, source along with
process of water treatment along
with source needs to be
submitted.
p. Packaging material/ container

closure specifications are not
submitted.
provided.Undertaking of
submitting before marketing of
the product, Description of
Suitability of container closure
system comprising of
parameters(i) Protection of
Drug(ii) Compatibility of
Drug(iii) Safety of Drug &(iv)
Performance of Drug (Stability
studies will establish the the
final suitability of container
section from licensing section is
not provided.
45
s. Last / latest inspection report
that should be conducted with in
six months from the date of
evaluation of dossier and having
detailed assessment of facility in
which the applied drug will be
t. CD of the dossier alongwith

contains the same information /
data as submitted by the
applicant in the dossier and that
the CD is in operative condition
is required.
u. Before marketing of the

product an undertaking that the
firm shall submit the clinical
trial data is required.
19. -do- Livbuvir400mg/60mg Form 5-D New application

Tablets
Each Film Coated Tablet 18-07-2014 (517) Satisfactory GMP (14-05-2013)
contains:- Rs.50,000/
Sofosbuvir (M.S).400mg
Daclatasvir(M.S).60mg As per SRO a. Signatures are required
(Anti-Viral) Pack size: to be verified whether
(Manufacturers Spec.s) 1 x10s, they have been done by
relevant persons (List of
the firm).
b. SOPs / procedure to record

and inform about the
change of person are
required.
c. Reference of Specifications
of Finished product is
required.
d. Evidence of international
approval/registration of
46
same salt, combination,
dosage form and strength in
reference countries like
FDA, EMA, TGA, Health
Canada etc along with date
of approval are not
provided.
e. At annexature II sovaldi is
mentioned instead of
combination which requires
correction.
f. Details of Reference
Secondary) being used are
required.
g. List of specific equipments /

tests of applied drug (e.g.,
Atomic Absorption
required.
h. Stepwise details of
including
registration.
i. Specifications of API
(incomplete and
ambiguous) along with
Source, certificate of
humans & not on clinical
trial are required.
47
j. You have submitted that
raw material of Daclatasvir
and sofosbuvir are stored at
days to weeks) and or -20
C for long term (months to
years) which requires
confirmation of storage
conditions for
transportation,
manufacturing etc at this
low temperature.
k. Identification of API by IR
requiredas it is not
list.
l. Proposed Price of product

not provided.
m. Complete dissolution
required.
n. Assay method under

finished product
incomplete. Moreover,
phenyl column is mentioned
and type of HPLC (gradient
or isocratic along with type
of detector is not
clarification.
o. Patient information leaflet

48
MHLW is
without reference.
p. Clinical data (along with

q. Stability studies, process

method data is not
Registration Board.
r. Complete details of HVAC

drug will be
for the following
100, 10 000, 100 000).
pressure.
49
s. Specifications of water used
t. Packaging material/
container closure
submitted.
u. Suitability of container
provided. Undertaking of
submitting before
marketing of the product,
Description of Suitability
of container closure system
comprising of parameters(i)
Protection of Drug(ii)
Compatibility of Drug(iii)
Safety of Drug &(iv)
Performance of Drug
(Stability studies will
establish the the final
suitability of container
v. Evidence of approval of
w. Last / latest inspection

x. CD of the dossier alongwith

50
contains the same
information / data as
submitted by the applicant
is required.
y. Before marketing of the

required.
20. M/s Genome Sofdac400mg/60mg Form 5-D New application

(Pvt) Ltd. Each Film Coated Tablet 14-07-2014 Satisfactory GMP. (27-12-2013)
contains:- Rs.20,000/- (3225)
Plot No. 16/1, Sofosbuvir (M.S).400mg 15-07-2014
Phase IV, Daclatasvir(M.S).60mg Rs.30,000/- a. Signatures are required
(Anti-Viral) As per SRO to be verified whether
Industrial Estate,
(Manufacturers Spec.s) Pack size: they have been done by
Hattar, Haripur, 28s, relevant persons (List of
KPK, signatures identification
the firm).
b. Dosage form is not

mentioned instead word oral
is given which requires
justification.
c. SOPs / procedure to record

required.
d. Reference of Specifications
required.
e. Evidence of international
approval/registration of
same salt, combination,
dosage form and strength in
51
of approval are not
provided.
f. At annexature II sovaldi is
mentioned instead of
combination which requires
correction.
g. Details of Reference
required.
h. List of specific equipments /

Atomic Absorption
required.
i. Stepwise details of
including
registration.
j. Specifications of API
(incomplete and
trial are required.
k. You have submitted that

raw material of Daclatasvir
52
conditions for
transportation,
low temperature.
l. Identification of API by IR
list.
m. Proposed Price of product

not provided.
n. Complete dissolution
required.
o. Assay method under

finished product
under equipment
detailsphenyl column is
mentioned and type of
HPLC (gradient or isocratic
along with type of detector
is not mentioned). This
needs clarification.
p. Patient information leaflet

53
MHLW is
without reference.
q. Clinical data (along with

r. Stability studies, process

method data is not
Registration Board.
s. Complete details of HVAC

drug will be
for the following
100, 10 000, 100 000).
pressure.
t. Specifications of water used

54
u. Packaging material/
container closure
submitted.
v. Suitability of container
provided. Undertaking of
submitting before
Performance of Drug
w. Evidence of approval of
x. Last / latest inspection

y. CD of the dossier alongwith

contains the same
55
is required.
z. Before marketing of the

required.
21. -do- Sofliver400mg/90mg Form 5-D New application

Tablets
Each Film Coated Tablet 14-07-2014 (3228) Satisfactory GMP. (27-12-2013)
contains:- Rs.20,000/-
Sofosbuvir (M.S).400mg 15-07-2014
Ledipasvir Rs.30,000/- a. Signatures are required
(M.S).90mg As per SRO to be verified whether
(Anti-Viral) Pack size: they have been done by
(Manufacturers Spec.s) 28s, relevant persons (List of
the firm).
b. Dosage form is not

mentioned instead word oral
is given which requires
justification.
c. SOPs / procedure to record

required.
d. Reference of Specifications
required.
e. Evidence of international
approval/registration in
of approval are not
provided.
f. Details of Reference
56
required.
g. List of specific equipments /

Atomic Absorption
required.
including
registration.
i. Specifications of API
(incomplete and
trial are required.
j. You have submitted that

raw material of Ledipasvir
is present as Ledipasvir
acetone solvate which is
removed during
manufacturing process, it
requires justification and
also not mentioned in
manufacturing process.
k. Identification of API by IR
57
list.
l. You have submitted that

raw material of Ledipasvir
conditions for
transportation,
low temperature.
m. Proposed Price of product

not provided.
n. Complete dissolution
required.
o. Assay method under

finished product
phenyl column is mentioned
and type of HPLC (gradient
or isocratic along with type
of detector is not
clarification.
p. Patient information leaflet

MHLW is
58
without reference.
q. Clinical data (along with

r. Stability studies, process

method data is not
Registration Board.
s. Complete details of HVAC

drug will be
for the following
100, 10 000, 100 000).
pressure.
t. Specifications of water used

59
u. Packaging material/
container closure
submitted.
v. Suitability of container
provided.Undertaking of
submitting before
Performance of Drug
w. Evidence of approval of
x. Last / latest inspection

y. CD of the dossier alongwith

contains the same
is required.
60
z. Before marketing of the
required.
Evaluator-II
22. M/s The Searle Sobvi 400mg Tablets Form 5-D FDA: Sovaldi (Gilead)
Company Limited
F-319 S.I.T.E Each Film Coated Tablet New application
Karachi contain:-
18-07-2014 (64) Issuance of GMP Certificate
Sofosbuvir400mg recommended (25-07-2013)
(Anti viral) a. Signatures are required to be

Rs. 50,000/-
verified whether they have been
(Manufacturers Spec.s)
done by relevant persons (List of
signatures identification by Chief
Rs. 30000/10s executive of the firm).
b. Master formulation with
Rs. 90000/30s scientific names as present in the
relevant pharmacopoeia and
quantities of all the ingredients
including excipients, Batch size,
Quantities to be used per Batch,
Source of active (with complete
address and CoA) and inactive
starting materials, Role of inactive
starting materials and the
Justification of their quantities used
is required. Formulation of coating
solution is also required.
c. Stepwise details of
manufacturing process including
Precautions/Control required to
produce specified quantities of the
drug applied for registration and
demonstration of cleaning
validation procedures,
Identification & description of
Critical steps which may alter the
results and tests for IPQC including
weight variation, hardness,
friability, water content, etc are
required.
d. Complete and updated
Specfications of inactive
61
materials/excipients with clear
pharmacopoeial reference are
required.
e. Details of Reference standard
(Primary or Secondary) being used
are required.
f. GMP report is not latest (should
be conducted with in six months
from the date of evaluation of
dossier and having detailed
assessment of facility in which the
applied drug will be manufactured
whether it is GMP compliant or
not.)
g. Undertaking of submitting
before marketing of the product,
Description of Suitability of
container closure system
Compatibility of Drug(iii) Safety of
Drug &(iv) Performance of Drug
(Stability studies will establish the
the final suitability of container
h. Before marketing of the product
an undertaking that the firm shall
submit the clinical trial data is
required.
23. M/s Winbrains Winofos 400mg Tablets Form 5-D FDA: Sovaldi (Gilead)
Research
Laboratories Plot Each Film Coated Tablet New application
contain:-
No. 69/1, Block B 15-07-2014 (330)
Phase 1 & 2 Sofosbuvir400mg Not clear (Legible), No
Industrial Estate conclusion (17-03-2014)
Hattar, Pakistan. (Anti viral)
Rs. 50,000/- a. Covering letter not signed
(Manufacturers Spec.s) by owner.
b. Signatures are required to be
Rs. 85000/Tablet verified whether they have
been done by relevant
persons (List of signatures
identification by Chief
executive of the firm).
c. Evidence of approval of
section / manufacturing
facility of applied drug from
62
licensing section is required.
d. Complete Description of
dosage form (e.g film
coated) of drug is required.
e. An
undertaking/commitment
(on prescribed format) as
per decision of Registration
Board regarding the
submission of (a) Stability
studies (b) Pharmaceutical
Development Studies(c)
Validation of analytical
testing methods studies (d)
Process validation (e) Label
claims and prescribing
information being same as
approved by reference drug
agencies e.g., FDA, TGA,
MHLW, EMA and Health
Canada is required.
f. Master formulation with
scientific names as present
in the relevant
pharmacopoeia and
excipients, Batch size,
Quantities to be used per
Batch, Source of active and
inactive starting materials,
Role of inactive starting
materials and the
Justification of their
quantities used is required.
g. Evidence of approval of
production in-charge from
licensing section is required.
h. SOPs / procedure to record
and inform about the change
of person are required.
i. Attested copy of Certificate
of Analysis of active raw
material with clear address
63
of manufacturers is
required.
j. Specifications of active raw
material with reference are
required.
k. Specification of finished
product are generalized.
Complete specifications
with reference are required.
l. Details of Reference
required.
m. Evidence of approval of the
persons working in quality
control from Licensing
section is required.
n. List of specific equipments /
Atomic Absorption
o. Complete details of Facility
of water processing, Source
of water , Specifications of
water are required.
p. Environmental control
processing with details,
Complete details of HVAC
drug will be manufactured
are required.
q. GMP report is not legible
and without any conclusion
of GMP status. Legible
copy of latest GMP
inspection report having
detailed assessment of
facility in which the applied
drug will be manufactured
(whether it is GMP
compliant or not) is
64
required.
r. Undertaking of submitting
before marketing of the
closure system comprising
of parameters(i) Protection
of Drug(ii) Compatibility of
&(iv) Performance of Drug
s. Undertaking by the
production and quality
control incharges about the
correctness of contents of
the dossier is required.
t. Undertaking that the CD
contains the same
is required.
u. Before marketing of the
required.
24. M/s Wel Wink Sofowink 400mg Tablets Form 5-D a.
Pharmaceuticals DA: Sovaldi (Gilead)
G.T Road, Each Film Coated Tablet
Industrial Estate contain:- b.
15-07-2014 (1529)
Gujranwala, Cantt. ew application
Sofosbuvir400mg
(Anti viral) c.
Rs. 50,000/- ot provided
(Manufacturers Spec.s)
d.
Rs. 85000/Tablet ignatures are required to
be verified whether they
have been done by
65
relevant persons (List of
the firm).
e.
vidence of approval of
section / manufacturing
facility of applied drug
from licensing section is
required.
f.
omplete Description of
dosage form (e.g film
coated) of drug is
required.
g.
n
undertaking/commitme
nt (on prescribed
format) as per decision
of Registration Board
regarding the
submission of (a)
Stability studies (b)
Pharmaceutical
Development Studies(c)
Validation of analytical
testing methods studies
(d) Process validation
(e) Label claims and
prescribing information
being same as approved
by reference drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada is
required.
h.
aster formulation with
scientific names as
present in the relevant
pharmacopoeia and
66
excipients, Batch size,
Quantities to be used
per Batch, Source of
active and inactive
starting materials, Role
of inactive starting
materials and the
Justification of their
quantities used is
required.
i.
production in-charge
from licensing section is
required.
j.
OPs / procedure to
record and inform about
the change of person are
required.
k.
ttested copy of
Certificate of Analysis
of active raw material
with clear address of
manufacturers is
required.
l.
pecifications of active
raw material with
reference are required.
m.
pecification of finished
product are generalized.
Complete specifications
with reference are
required.
n.
etails of Reference
Secondary) being used
are required.
o.
67
the persons working in
quality control from
Licensing section is
required.
p.
ist of specific
equipments /
tests of applied drug
(e.g., Atomic
Absorption
q.
omplete details of
Facility of water
processing, Source of
water , Specifications of
water are required.
r.
nvironmental control
processing with details,
Complete details of
HVAC under which the
manufactured are
required.
s.
opy of Last GMP report
not provided. GMP
report (should be
evaluation of dossier
and having detailed
assessment of facility in
which the applied drug
will be manufactured
whether it is GMP
compliant or not.) is
required.
t.
ndertaking of
68
submitting before
marketing of the
closure system
comprising of
parameters(i) Protection
of Drug(ii)
Compatibility of
&(iv) Performance of
Drug (Stability studies
will establish the the
final suitability of
container closure
u.
ndertaking by the
production and quality
control incharges about
the correctness of
contents of the dossier
is required.
v.
D of the dossier
alongwith Undertaking
that the CD contains the
same information / data
as submitted by the
applicant in the dossier
and that the CD is in
operative condition is
required.
w.
efore marketing of the
product an undertaking
that the firm shall
submit the clinical trial
data is required.
Evaluator-III
25. M/s Werrick Cell-Tab Tablets 400mg Form-5D a. Attested copy of DML or
Pharmaceuticals, renewal in case of more than
Each film coated tablet five years.
69
216-217, I-10/ 3, contain b. Evidence of approval of
Industrial Area, Sofosbuvir400mg technical staff from Licensing
Islamabad. Dy No 1665 dated 17- c. Specifications of API along
Nucleotide analogue Inhibitor 07-2014 with source & certificate of
of HCV NS5B Polymerase analysis.
d. Complete dissolution testing
method with details of
50,000/- dissolution medium, RPM speed
Manufacturer etc. along with the acceptance
criteria is required.
e. Clinical data (along with data
Rs.10,000/- per tablet of clinical trials conducted and
Pack of 14s & 28s reoprted side effect and adverse
drug reactions in indigenous
community along with clinacal
justification as per requiremnet
of Form-5D.
f. Complete details of HVAC
parameters: Particulate matter
(Mention the class of area (A,
B, C, D or class 100, 10 000,
100 000).
pressure.
g. Packaging material/ container
closure specifications are not
submitted.
h. Suitability of container
system comprising of following
Compatibility of Drug, Safety of
Drug & Performance of drug.
i. Evidence of approval of section
from licensing section is not
provided.
j. Last / latest inspection report
that should be conducted with in
six months from the date of
evaluation of dossier and having
detailed assessment of facility in
which the applied drug will be
70
Inspection of the firm was

conducted on 29/05/12 by the
area FID and GMP compliance
was found very good and
advised to continue the process
of up gradation..
26. M/s Wilsons Saferon Tablets 400mg Form-5D a. Attested copy of DML or
Pharmaceuticals, I- renewal in case of more
9, Industrial Area, than five years.
b. Evidence of approval of
Islamabad.
Each film coated tablet Dy No 1666 dated 17- technical staff from
contain 07-2014 Licensing
Sofosbuvir400mg c. Specifications of API
along with source &
certificate of analysis.
50,000/- d. Complete dissolution
Nucleotide analogue Inhibitor testing method with details
of HCV NS5B Polymerase of dissolution medium,
Rs.10,000/- per tablet the acceptance criteria is
required.
Manufacturer Pack of 14s & 28s e. Clinical data (along with
f. Complete details of HVAC
drug will be
for the following
matter (Mention the class
of area (A, B, C, D or class
100, 10 000, 100 000).
pressure.
g. Packaging material/
container closure
submitted.
71
h. Suitability of container
closure system has not
been provided. An
undertaking of submitting
description of suitability of
container closure system
comprising of following
parameters:Protection of
Drug, Compatibility of Drug,
Safety of Drug& Performance
of drug.
i. Evidence of approval of
section from licensing section
is not provided.
j. Last / latest inspection
Inspection of the firm was

conducted on 25/04/13 by the
area FID and made conclusion
that firm was operating at good
level of compliance with GMP
guidelines.
27. M/s Biogen Sofobugen Tablets 400mg Form 5 a. Submitted application is on

Pharma, 8Km Form-5, which needs to be
Chak Beli Road, submitted on Form 5D
Rawat Rawalpindi. b. Complete description of
Each film coated tablet Dy No: 1672 dated 18- dosage form is required.
contains 07-14 c. Unit price of applied drug is
Sofosbuvir..400mg written as decontrolled which
50,000/- requires clarification.
Antiviral d. Attested copy of DML or
Decontrolled renewal in case of more than
Manufacturer five years.
Pack of 14s & 28s e. Evidence of approval of
section from licensing is
required.
f. Stepwise details of
including
72
registration.
g. Specifications submitted for
API are in complete, so
complete specifications of
API along with source and
certificate of analysis is
required.
h. Ambiguous finished product
specifications are submitted.
Identification test, assay
method, performance tests
along with equipment details
used in testing needs to be
submitted.
i. Patient information leaflet
MHLW is required.However
the submitted iformation is
of brand leader
j. Clinical data (along with data
of clinical trials conducted
and safety data of drug, with
reoprted side effect and
adverse drug reactions in
indigenous community along
with clinacal justification as
per requiremnet of Form-5D.
k. Stability studies, process
method data is not submitted.
However you may submit an
undertaking to submit data of
the same before marketing of
drug product for
consideration of Registration
Board.
l. Complete details of HVAC
73
area (A, B, C, D or class 100,
10 000, 100 000).
pressure.
m. Specifications of water used
applied product, source along
with process of water
n. Packaging material/
container closure
submitted.
o. Suitability of container
system comprising of following
Compatibility of Drug, Safety
of Drug& Performance of drug.
p. Evidence of approval of section
from licensing section is not
provided.
q. Last / latest inspection report
that should be conducted
with in six months from the
date of evaluation of dossier
and having detailed
assessment of facility in
which the applied drug will
be manufactured whether it
is GMP compliant or not.
28. M/s Valor Sofovir-C/ Hepavir/ Virolys Form-5 a. Submitted application is on
Pharmaceuticals Capsules 400mg Form-5, which needs to be
(Pvt) Limited, 124/ submitted on Form 5D
along with differential fee
A, Kahuta Dy No 1559 dated 14- required under the rules.
Industrial Triangle 07-14 b. Attested copy of DML or
Each capsule contains
Zone, Islamabad.
Sofosbuvir..400mg renewal in case of more
20,000/- than five years.
Antiviral Agent c. Evidence of approval of
Not provided section from licensing.
Manufacturer d. Evidence of approval of
technical staff from
licensing section needs to be
74
submitted.
e. Evidence of approval of
same dosage form, strength
and clinical use along with
the dosage from FDA,
EMA, TGA, Health Canada
and MHLW.
f. Master formulation with
excipients, batch sizeBatch
size, quantities to be used
per batch, source of active
and inactive starting
materials, role of inactive
starting materials and the
justification of their
quantities used, needs to be
submitted.
g. Tablet manufacturing
equipment/ machinery is
submitted under outline of
method manufacture. This
needs clariifcation.
including
registration.
i. Complete specifications of
API along with the source
and certificate of analysis is
required
j. Ambiguous finished product
specifications are submitted.
Identification test, assay
method, performance tests
along with equipment
details used in testing needs
to be submitted.
75
MHLW is
submitted iformation is of
brand leader
l. Clinical data (along with
conducted and safety data of
drug, with reoprted side
method data is not
Registration Board.
drug will be
for the following
100, 10 000, 100 000).
pressure.
p. Packaging material/
container closure
submitted.
76
closure system comprising
of following
parameters:Protection of
Drug, Compatibility of
Drug, Safety of Drug&
Performance of drug.
s. Last / latest inspection
Evaluator-IV
29. M/s Weatherfolds Winofold Tablet 400 mg Form 5 D International: Sovaldi Tablet
Pharmaceuticals Each tablet contains 15-07-2014 400 mg (FDA)
69/ 2, Phase II, Sofosbuvir400 mg Rs 50000/- Local: New drug
industrial estate, (Nucleotide Analog NS5B Rs 85,000/ tablet a. Covering letter of Form 5
Hattar Polymerase Inhibitor) Blister Pack alu alu D has not been signed.
10s b. In composition of tablet on
Finished product Form 5 D, just tablet is
specifications are written while in actual
Manufacturer tablet is film coated.
c. Details regarding source of
active & inactive materials
have not been provided in
dossier.
d. Justifications of quantities
of ingredients used (with
reference) have not been
provided.
e. No authentic reference to
clinical use & doses given
in clinical part of dossier
f. Firm has not provided QC
equipment list.
g. QC tests for tablets like
disintegration, weight
variation, diameter,
hardness etc have not been
given
h. Analytical detail of
finished product has not
77
been provided.
i. General dissolution method
has been given. Dissolution
of applied product has not
been given.
j. Detail of reference
standards being used have
not been submitted
k. No SOP/ procedure to
record & inform about
change of technical person
has been provided.
l. Approval of technical
person form DRAP has not
been provided as persons
mentioned on For 5 D are
different from those
mentioned in inspection
report.
m. Undertaking regarding
correctness/ genuiness of
contents of CD has not
been given.
n. Undertaking to refrain
from counterfeiting has not
been provided.
o. Undertaking to conduct
clinical trials in indigenous
p. Environment control
processing (HVAC detail,
temp, humidity, class of
area, air pressure, air
velocity) has not been
provided
q. Water processing system
(source and specifications
of water (with reference)
has not been given.
r. On inspection report dated
22-03-2014, FID advised
improvements in various
sections.
s. For studies like process
validation, stability studies,
pharmaceutical
development studies &
methods, an undertaking
may be submitted
regarding the provision of
78
the same before marketing
of said product.
t. For Summary of Product
Characteristics (SmPC),
Patient information leaflet
(PIL) Prescribing
Information (PI), you may
submit an undertaking that
said information would be
same as approved by
reference drug agencies
like FDA, TGA, MHLW,
EMA and Health Canada.
u. Undertaking of correctness
of dossier has not been
provided.
v. Internationally products
packaging material is bottle
while firm is providing alu
alu blister pack. Provide
how this packaing will not
affect stability.
w. Firm has not provided
clinical justification.
On inspection report dated 22-

03-2014, FID advised
improvements in various
sections.
30. M/s Welmark Sofomark Tablet 400 mg Form 5 D International: Sovaldi Tablet
Pharmaceuticals, Each tablet contains 15-07-2014 400 mg (FDA)
Plot No. 122, Sofosbuvir400 mg Rs 50,000/- Local: New drug
Block B, Phase (Nucleotide Analog NS5B Rs 85,000/ tablet a. In composition of tablet on
5, Industrial Polymerase Inhibitor) Blister Pack alu alu Form 5 D, just tablet is
Estate, Hattar 10s written while in actual tablet
Finished product is film coated.
specifications are b. Details regarding source of
Manufacturer active & inactive materials
dossier.
c. Justifications of quantities
provided.
d. No authentic reference to
clinical use & doses given in
clinical part of dossier
e. Firm has not provided QC
equipment list.
f. Analytical detail of finished
product has not been
79
provided.
g. General dissolution method
been given.
h. Detail of reference standards
being used have not been
submitted
i. No SOP/ procedure to
has been provided.
j. Approval of technical
been provided.
k. Undertaking regarding
contents of CD has not been
given.
l. Undertaking to conduct
m. Undertaking to refrain from
counterfeiting has not been
provided.
n. Environment control
provided
o. Water processing system
(source and specifications of
water (with reference) has
not been given.
p. Undertaking of correctness
provided.
q. QC tests for tablets like
given.
r. Firm has not provided
According to inspection report

dated24-05-2014 has been
attached.
31. M/s Welward Sofoward Tablet 400 mg Form 5 D International: Sovaldi Tablet
80
Plot No. 3, Block Sofosbuvir400 mg Rs 50,000/- Local: New drug
A, Phase I-II, (Nucleotide Analog NS5B Rs 85,000/ tablet a. In composition of tablet on
Industrial Estate, Polymerase Inhibitor) Blister Pack alu alu Form 5 D, just tablet is written
Hattar 10s while in actual tablet is film
Finished product coated.
dossier.
c. Justifications of quantities of
ingredients used (with
provided.
equipment list.
provided.
has been given. Dissolution of
applied product has not been
given.
submitted
i. No SOP/ procedure to record
& inform about change of
technical person has been
provided.
j. Approval of technical person
form DRAP has not been
provided.
given.
l. Undertaking to conduct
m. Environment control
temp, humidity, class of area,
air pressure, air velocity) has
not been provided
x. Internationally products
while firm is providing alu alu
blister pack. Provide how this
81
packaing will not affect
stability.
n. Water processing system
water (with reference) has not
been given.
o. Undertaking of correctness of
dossier has not been provided.
p. QC tests for tablets like
variation, diameter, hardness
etc have not been given.
q. Firm has not provided clinical
justification.

dated 25-07-2014, firm was
considered to be operated a
good level of compliance with
GMP guidelines.
32. M/s Wnsfeild Winovir Tablet 400 mg Form 5 D International: Sovaldi Tablet
Plot No.122, Block Sofosbuvir400 mg Rs 50,000/- Local: New drug
A, Phase V, (Nucleotide Analog NS5B Rs 85,000/ tablet a. In composition of tablet on
Industrial Estate, Polymerase Inhibitor) Blister Pack alu alu Form 5 D, just tablet is
Hattar 10s written while in actual tablet
Finished product is film coated.
dossier.
c. Justifications of quantities
provided.
equipment list.
y. Internationally products
while firm is providing alu alu
blister pack. Provide how this
packaing will not affect
stability.
z. Undertaking to conduct
82
provided.
been given.
submitted
i. No SOP/ procedure to
has been provided.
j. Approval of technical
been provided.
given.
l. Environment control
provided
m. Water processing system
not been given.
n. Undertaking of correctness
provided.
o. QC tests for tablets like
given.
p. Firm has not provided
q. For studies like process
validation, stability studies,
pharmaceutical development
studies & validation of
analytical methods, an
undertaking may be
submitted regarding the
provision of the same before
marketing of said product.
r. For Summary of Product
Characteristics (SmPC),
Patient information leaflet
83
(PIL) Prescribing
Information (PI), you may
submit an undertaking that
said information would be
same as approved by
reference drug agencies like
FDA, TGA, MHLW, EMA
and Health Canada.
33. M/s Hiranis Safliv Tablet 400 mg Form 5 D International: Sovaldi Tablet
Pharmaceuticals Each film coated tablet 16-07-2014 400 mg (FDA)
(Pvt) Ltd contains Rs 50,000/- Local: New drug
Plot No. E-145E- Sofosbuvir400 mg As per PRC a. Details regarding source of
149, North West (Nucleotide Analog NS5B active & inactive materials
Industrial Zone, Polymerase Inhibitor) have not been provided in
Port Qasim, dossier.
Karachi. Finished product b. Justifications of quantities of
specifications are ingredients used (with
Manufacturer reference) have not been
provided.
c. No authentic reference to
d. Specifications and analytical
detail of active raw material
have not been provided.
e. Detail of reference standards
submitted
f. No SOP/ procedure to record
& inform about change of
technical person has been
provided.
g. Approval of technical person
form DRAP has not been
provided.
h. Undertaking regarding
given.
i. Environment control
temp, humidity, class of area,
air pressure, air velocity) has
not been provided
j. Water processing system
not been given.
k. Undertaking to conduct
84
l. Undertaking of correctness of
dossier has not been signed
by Production Manager.
dated 23-09-2013, panel
recommended grant of DML by
way of Formulation.
Evaluator-V
34. M/s Dyson Sovir 400mg Tablets Form 5D a. Stability Studies
Research conducted under the Zone
Laboratories (Pvt) Film coated tablets 17/07/2014 IV-A conditions as per ICH /
Ltd., 28 Km, 1628 R&I WHO Guidelines have not
Each film coated tablet
Ferozpur Road, contains: been provided. However,
Lahore. 17/07/2014 undertaking has been
Sofosbuvir . 400mg submitted for consideration
(Rs. 50,000/-) by the Board.
Direct acting antiviral
28s As per SRO b. An undertaking that in
Manufacturers specifications case of resemblance /
similarity, the applicant
Source of API: Medchen
would be liable to change the
Express (Caution: Not fully
brand name.
tested. For research
purpose only) c. Prescribing information
(PI), Patient Information
Leaflet (PIL) and Summary
of product characteristics
(SmPC) as per Approved by
Drug regulatory agencies or
authorities of country of
origin or FDA, EMA, TGA,
Health Canada and MHLW
(Japan)
d. Indigenous clinical
trials data required.
e. Complete API
specifications required along
with clarification regarding
caution on the COA.
f. Steps for control of

particle size of API not
provided as Sofosbuvir has
low apparent intestinal
85
permeability (BCS class III)
and since particle size has
been found to be critical for
dissolution rate.
SOVALDI
400mg f/c tablet
US FDA
GMP report dated 15/02/2013.

As per the conclusion of the
report the firm needs further
improvement regarding up
gradation of their SOPs batch
manufacturing records and
method of test / analysis as per
current pharmacopeias. They
were advised to improve all
shortcoming and intimate for re-
inspection.
35. M/s Shrooq Sofvir 400mg Tablets Form 5D a. Stability Studies conducted
Pharmaceuticals under the Zone IV-A conditions
(Pvt) Ltd., 21 Km, Film coated tablets as per ICH / WHO Guidelines
Ferozpur Road, Each film coated tablet 17/07/2014 have not been provided.
Lahore. However, undertaking has been
contains:
1641 R&I submitted for consideration by
Sofosbuvir . 400mg the Board.
17/07/2014
Direct acting antiviral b. An undertaking that in case of
(Rs. 50,000/-) resemblance / similarity, the
Manufacturers specifications applicant would be liable to
Rs. 4,500/- per 28s
change the brand name.
Source of API: Not
mentioned c. Prescribing information (PI),
Patient Information Leaflet
(PIL) and Summary of product
characteristics (SmPC) as per
Approved by Drug regulatory
agencies or authorities of
country of origin or FDA,
86
MHLW (Japan)
d. Indigenous clinical trials data

required.
e. Complete details regarding

API e.g., specification, source,
COA etc., required.
f. Steps for control of particle

size of API not provided as
Sofosbuvir has low apparent
intestinal permeability (BCS
class III) and since particle size
has been found to be critical for
dissolution rate.
g. Manufacturing method is
overly simplistic. A detailed
stepwise method including
precautions / controls required
to produce specified quantities
of the drug and demonstration
of cleaning validation
procedures. Details of IPQC
tests are also required.
h. Identifications test(s) have

not been mentioned. Assay has
been proposed using the UV
spectrometer. A suitable assay
method with HPLC along with
test for impurities, degradation
products etc., needs to be
provided along with details of
other tests like content
uniformity, dissolution,
disintegration, hardness etc.
i. An undertaking that labeling

and prescribing information
shall be as approved by FDA,
TGA, EMA, Health Canada or
MHLW (Japan).
j. Environmental control /
87
HVAC details of injectable
section have been provided
instead of tablet section.
k. List of manufacturing
equipment of injectable section
has been provided instead of
tablet section.
l. Packaging material
specifications of injectable
dosage form has been provided
instead of tablet.
SOVALDI
400mg f/c tablet
US FDA
GMP certificate issued on 20-

06-2014provided.
36. M/s McOlson Sofo 400mg Tablets Form 5D a. Stability Studies conducted
Research under the Zone IV-A conditions
Laboratories (Pvt) Film coated tablets 17/07/2014 as per ICH / WHOGuidelines
Ltd., M-2 Pharma Each film coated tablet 1629 R&I have not been provided.
Zone, 26 Km, contains: However, undertaking has been
Sharikpur Road, 17/07/2014 submitted for consideration by
Sheikhupura. Sofosbuvir . 400mg the Board.
(Rs. 50,000/-)
Direct acting antiviral b. An undertaking that in case of
28s As per SRO resemblance / similarity, the
Manufacturers specifications applicant would be liable to
Source of API: Medchen
Express (Caution: Not fully c.Prescribing information (PI),
tested. For research Patient Information Leaflet
purpose only) (PIL) and Summary of product
88
MHLW (Japan)
d. Indigenous clinical trials data

required.
e. Complete API material

specifications along with
clarification regarding caution
on the COA.
f. Steps for control of particle

dissolution rate.
SOVALDI
400mg f/c tablet
US FDA
GMP report for grant of GMP

certificate for export purpose
dated 17/07/2013. Good
compliance reported.
37. M/s Valor Hepavir 400mg Tablets Form 5D 1. Stability Studies conducted
Pharmaceuticals, under the Zone IV-A conditions
Tablets 18/07/2014
124/A, Industrial as per ICH / WHOGuidelines
Area, Kahuta Each tablet contains: 1671 R&I have not been provided.
Road, Islamabad. However, an undertaking /
Sofosbuvir . 400mg 18/07/2014 commitment regarding the
submission of following before
Antiviral (Rs. 50,000/-) marketing the product, as per
decision of the Registration
Manufacturers specifications 10s MRP not
Board, may be submitted for
mentioned
Source of API: consideration by the Board:
a. Stability studies
b. Pharmaceutical
development studies
89
c. Validation of analytical
testing methods
d. Process validation
e. Label claim and

prescribing information
being same as approved by
reference drug agencies e.g.,
FDA, TGA, MHLW, EMA
and Health Canada.
2. An undertaking that in case of

resemblance / similarity, the
applicant would be liable to
3. Prescribing information (PI),

Patient Information Leaflet
(PIL) and Summary of product
MHLW (Japan)
4. Indigenous clinical trials data

required.
5. Complete details regarding

API e.g., specification, source,
COA etc., required.
6. Steps for control of particle

dissolution rate.
7. Apparently an uncoated tablet

has been proposed. Since the
innovator product is film coated
therefore, formulation needs to
90
be revised. Moreover, batch
formulation mentioning
quantities to be used per batch
along with batch size required.
8. Manufacturing method is
overly simplistic. A detailed
stepwise method including
precautions / controls required
to produce specified quantities
of the drug and demonstration
of cleaning validation
procedures. Details of IPQC
tests are also required.
9. Identifications test(s) have

not been mentioned under API
and finished product
specifications. Assay has been
proposed using the UV
spectrophotometer. A suitable
assay method with HPLC along
with test for impurities,
degradation products etc., needs
to be provided along with
details of other tests like content
uniformity, dissolution,
disintegration, hardness etc.
10. An undertaking that labeling

and prescribing information
shall be as approved by FDA,
TGA, EMA, Health Canada or
MHLW (Japan).
11. Copy of DML, evidence of

renewal (if applicable) and
evidence of approval of tablet
section required.
12. Complete packaging

material specifications required.
13. Packaging material

specifications of injectable
dosage form has been provided
91
instead of tablet.
14. Latest GMP inspection

report required.
15. Proposed MRP has not been

mentioned.
SOVALDI
400mg f/c tablet
US FDA
GMP report not provided.
Decision: Registration Board considered new drug application of Sofosbuvir Tablet which is the
new therapy approved by US FDA for treatment of Hepatitis C infection in December, 2013. Dr.
Huma Qureshi, Executive Director, Pakistan Medical Research Council and Secretary Technical
Advisory Group (TAG) on Viral Hepatitis also attended the meeting on special invitation of the
Board. She informed Registration Board that in Pakistan prevalence of Hepatitis C is 5% which
is 2nd highest in the world after Egypt. TAG on viral hepatitis in its meeting recently discussed
the new therapy and it was strongly recommended that this new treatment be made available to
Hepatitis C patients on urgent basis in the country. Keeping in view recommendations of TAG,
Registration Board unanimously agreed that Sofosbuvir tablet should be registered on priority
basis if other regulatory requirements are met. Accordingly, the Board considered the evaluation
reports of registration dossiers, replies of applicants and decided as follows:
Sovaldi Tablet 400 mg, Manufactured by M/s Patheon Inc., 2100 Syntex Court,
Mississauga, Ontario, L5N 7K9, Canada imported by M/s Ferozsons Laboratories Limited
P.O. Ferozsons Amangarh- Nowshera. Pakistan
A consolidated CoPP verifying manufacturing, packaging and release sites from EMA
(European Medicines Agency) for white coloured Tablets with Free Sale / Marketing status in
EMA. In case, white coloured tablets are not freely available in country of origin, the comparable
quality will be assessed from process validation and stability studies.
Locally manufactured Sofosbuvir Tablets:
92
In addition to individual dossier deficiencies, every manufacturer will provide additional data as
decided by Registration Board in 240 th meeting for new drug molecule. Meanwhile, honorable
Lahore High Court, Lahore shall be informed of decision of Registration Board regarding
applications of M/s Everest Pharma, Islamabad.
Case No.02. Left over M-242 agenda.
S/ Name and 1. Brand Name 1.Type of Form 1. Finished Decision

N address of 2. Dosage Form 2. Type of Product
manufacturer/ 3. Composition application Specification
Applicant 4. 3. Demanded Price / 2. Me-too status
Pharmacological Pack size 3. International
group 4. Initial date, diary. Status
5. Date on which fee
becomes complete
according to type of
application /or Form
(total Fee)
Registration-II
38. M/s Nabiqasim 1.Loprot Insta 1.Form5 Omega rapid Deferred for review of
Industries Pvt Ltd. 2.Oral Suspension 2.Routine (Ferozesons) formulation by review
17/24, Korangi 3.Each sachet 3. 7,10s/As per PRC committee
industrial Area, contains: 4.14-7-2010 FDA: Generic (Par
Karachi.
Omeprazole Dy.No.1332 Pharm)
..20 mg Rs.8000/-
Sodium (Original)
Bicarbonate (as 14-5-2013
Buffer)..1680 mg Rs.12,000/
4.Ant-ulcerant (Photo copy)
39. -do- 1.Reliefal 1.Form5-D BNF : Solubel Deferred for expert

2. Tablets 2.Routine (dispersible) opinion of Prof.
3.Each orally 3. 10s,20s/As per Tablets M.H.Najmi, Prof.Rauf
dispersible tablet PRC Niazi and Prof. Zafar
contains:- 4.03-08-2010 Iqbal. Moreover firm
Paracetamol B.P Dy.No.1517 will provide data as
.500mg Rs.15000/- decided for new
4.Analgesic (Original) dosage form in 240th
14-5-2013 meeting
Rs.12,000/-
Rs.23,000/-
(18-07-2014)
40. -do- 1.Vortex 1. Form-5 Me too status Approved.

2.Tablet 2.Routine confirmed
3.Each film coated 3. 10s / As per PRC Vozo
93
tablet contains: 4.10-08-2010 50mg&200mg of
Voriconazole. Dy.No.1538 M/s Hilton
..50mg Rs.8000/- Pharma,
Mfg. Spec. NQ (Original) (Reg.No.053214&
4.Broad Spectrum, 14-5-2013 061162)
trizole Antifungals Rs.12,000/-
(Photo copy) FDA: Vfend
41. -do- 1.Dinor 1. Form-5 Me too status Approved
2.Tablet 2.Routine confirmed.
3.Each film coated 3. 10s,14s,30s
tablet contains: As per PRC FDA: Januvia
Sitagliptin 4.24-08-2010
Phosphate Dy.No.1606
monohydrate Rs.8000/-
equivalent to (Original)
Sitagliptin 14-5-2013
100mg Rs.12,000/-
Mfg. Spec. NQ. (Photo copy)
4.Oral
Hypoglycaemic
42. -do- 1.Vortex 1. Form-5 Me too status Approved.
3.Each film coated 3. 10s/As per PRC Vozo
tablet contains: 4.11-08-2010 50mg&200mg of
Voriconazole Dy.No.1555 M/s Hilton
200mg Rs.8000/- Pharma,
Mfg.Specs.NQ (Original) (Reg.No.053214&
4.Broad 14-5-2013 061162)
spectrum,triazole Rs.12,000/-
antifungals (Photo copy) FDA: Vfend
43. -do- 1.Tensel 1. Form-5 Me too status Approved.

3.Each tablet 3. 14s/As per PRC
contains: 4.10-08-2010 FDA: Bystolic
Nebivolol HCI Dy.No.1541
equivalent to Rs.8000/-
Nebivolol..2.5mg (Original)
4.Anti- 14-5-2013
hypertensive Rs.12,000/-
(Photo copy)
44. -do- 1.Histec Flash 1. Form-5 Me too status Deferred for

2.Tablets 2.Routine confirmed for confirmation of me-
3.Each tablet 3. Rs.150/10s plain tablet too status in flash
contains:- Rs.450/30s (dispersible) dosage
Levocetirizine 4.03-08-2010 FDA: Xyzal form
Dihydrochloride Dy.No.1529
..5mg Rs.15000/-
4.Anti Histamine (Original)
14-5-2013
94
(Photo copy)
45. -do- 1.Loprot Insta 1. Form-5 Omega rapid Deferred for review of
2.Oral Suspension 2.Routine (Ferozesons) formulation by review
40mg 3. 7s,10s/As per committee.
3.Each sachet PRC FDA: Generic (Par
contains: 4.14-7-2010 Pharm)
Omeprazole Dy.No.1331
..40 mg Rs.8000/-
Sodium (Original)
Bicarbonate (as 14-5-2013
Buffer)..1680 mg Rs.12,000/-
4.Ant-ulcerant (Photo copy)
46. -do- 1.Dinor 1. Form-5 Me too status Approved.

2.Tablet 2.Routine confirmed.
3.Each film coated 3. 10s,14s.30s
tablet contains: As per PRC FDA: Januvia
Sitagliptin.50mg 14-5-2013
Mfg. Spec. NQ. Rs.12,000/-
4.Oral (Photo copy)
Hypoglycaemic
47. -do- 1.Misocot 1. Form 5 Confirmation of Deferred for Product
2.Tablet 2.Routine manufacturing specific inspection by
3.Each tablet 3. 10s,20s/As per facility is required. panel comprising of
contains: PRC Director DTL, DDG
Diclofenac sodium 4.01/07/2010 FDA: Arthrotec (E&M) and area FID
BP..75mg Dy. No. 1272
Misoprostol Rs. 8000/-
...200mcg (Original)
4.NSAIDS 14-5-2013
Rs.12,000/-
(Photo copy)
95
48. ` -do- Tensel 10mg Tab. 1. Form-5 It is a me too Approved
` Each tablet 2.Routine
contains: 3. 14s/As per PRC FDA: Bystolic
Nebivolol HCI 4.10-08-2010
equivalent to Dy.No.1539
Nebivolol.10mg Rs.8000/-
(Anti- (Original)
hypertensive) 14-5-2013
Rs.12,000/-
(Photo copy)
49. -do- 1.Dinor 1. Form-5 Me too status Approved

3.Each film coated 3. 10s.14s,30s/As
tablet contains: per PRC FDA: Januvia
Sitagliptin.25mg 14-5-2013
Mfg. Spec. NQ. Rs.12,000/-
4.Oral (Photo copy)
Hypoglycaemic
50. -do- 1.Loprot plus 1. Form-5 Bios (Werrick) Deferred for review of
2.Capsule 2.Routine formulation by review
3.Each capsule 3. 7s,10s,14s/ As FDA: Generic (Par committee
contains: per PRC Pharm)
Omeprazole 4.14-07-2010
.40 mg Dy.No.1333
Sodium Rs.8000/-
Bicarbonate.. (Original)
1100 mg 14-5-2013
4.Ani-ulcerant Rs.12,000/-
(Photo copy)
51. M/s Macter 1.Silo 1. Form-5 FDA : Januvia Approved

International Ltd. 2.Tablet 2.Routine
F-216, SITE, 3.Each film coated 3. 14s/As per PRC Me too status
Karachi tablet contains: 4.31-08-2010 confirmed.
Sitagliptin..25mg Dy.No.1617
4.Anti-diadetic Rs.8000/-
(Original)
22-5-2013
Rs.12,000/-
(Photo copy)
52. M/s Getz 1.Macrol 1. Form-5 D 1. it was new drug Approved

Pharma (Pvt) 2.Oral Solution 2.Routine at the time of
Limited 29,30, 3.Each Sachet 3. Rs.750/10s application
96
Sector-27, contains: 15-7-2010 2. The formulation
Korangi Macrogol Dy.No.1348 is MHRA
Industrial Area, ..13.125 g Rs.15000/- approved
Karachi-74900 Sodium 13-5-2013 3. The firm has
Chloride Rs.5,000/- applied on from 5-
.350.7 mg D. But it has
Sodium deposited fee of
Bicarbonate only Rs.20,000/-.
...178.5 mg 4. The differential
Potassium fee of Rs.30,000/-
Chloride has to be
....46.6 mg deposited by the
4.Osmotic applicant.
Laxative
MHRA approved
The firm has now

provided me too
status of Mavcol
of Genix (061629)
53. M/s Bosch 1.Zisul 1. Form-5 Int. avail not Approved
Pharma Kar. 2.Tablet 2.Routine confirmed in
3.Each tablet 3. Rs.100/10s stringent DRAs
contains: Rs.200/20s but formulation is
Zinc Sulphate a Rs.300/30s recommended by
monohydrate eq. to 4.22-07-2010 WHO.
Elemental Zinc..20 Dy.No.1382
mg Rs.8000/-
4.Treatment of 20-5-2013
diarrhea Rs.12,000/-
54. -do- 1.Calamox ES 1. Form-5 FDA: Generic Deferred for

2.Oral Suspension 2.Routine (Teva) confirmation of me
3.Each ml 3. Rs.225/75ml too status
contains: Rs.375/125ml Me too status need
Amoxycillin as Rs.600/200ml sconfirmation
Trihydrate. 4.22-07-2010
600 mg Dy.No.1390
Clavulanic acid as Rs.8000
potassium salt 20-5-2013/-
42.9 gm Rs.12,000/-
4.Antibiotic /
antibacterial for
microbial diseases
55. -do- 1.Inzopt 1.Form5 Me too status Approved

2.Sterile 2.Routine confirmed.
Ophthalmic Eye 3. Rs.700/5ml
drop 4.22-07-2010 FDA: Azopt
3.Each ml Dy.No.1389
contains: Rs.8000/-
97
Brinzolamide 20-5-2013
..10 mg Rs.12,000/-
4.Antiglaucoma
preparations and
miotics carbonic
anhydrase
inhibitors
56. -do- 1.Emeda 1.Form5 Me too status Approved
2.Eye Drops 2.Routine confirmed
3.Each ml 3. Rs.275/5ml
contains: 4.22-07-2010 FDA: Emadine
Emedastine Dy.No.1381
Difumerate eq. to Rs.8000/-
Emedastine.. 0.5 20-5-2013
mg Rs.12,000/-
4.Anti Allergic
Agent
57. -do- 1.Izilon 1.Form5 Me too status Approved

2.Eye Drops 2.Routine confirmed
contains: 4.22-07-2010 FDA: Moxeza
Moxifloxacin HCl Dy.No.1383
eq. to Rs.8000/-
Moxifloxacin 20-5-2013
.5 mg Rs.12,000/-
4.Synthetic Broad
Spectrum
antibacterial agent
58. -do- 1.Optibet 1.Form5 Me too status Approved
2.Eye Drops 2.Routine confoirmed
3Each ml contains: 3. Rs.225/5ml
Betaxolol HCl eq. 4.22-07-2010 FDA: Betoptic
to Betaxolol5 Dy.No.1379
mg Rs.8000/-
4.Cardioselective 20-5-2013
Beta-1adrenergic Rs.12,000/-
59. -do- 1.Codor 1.Form5 It is me too. Approved

2.Eye Drops 2.Routine Timorex D (Vega)
contains: 4.22-07-2010 FDA: Cosopt
Dorzolamide HCl Dy.No.1384
eq. to Rs.8000/-
Dorzolamide. 20-5-2013
20 mg Rs.12,000/-
Timolol Maleate
eq to
Timolol.5mg
4.Beta Blocker/
98
carbonic anhydrase
inhibitor
60. -do- 1.Zisul 1.Form5 Int. avail not Approved

2.Tablet 2.Routine confirmed in
3.Each tablet 3. Rs.50/10s stringent DRAs
contains: Rs.100/20s but formulation is
Zinc Sulphate a Rs.150/30s recommended by
monohydrate eq. to 4.22-07-2010 WHO.
Elemental Dy.No.1385
Zinc..10 mg Rs.8000/-
4.Treatment of 20-5-2013
diarrhea Rs.12,000/-
61. -do- 1.Calamox-XR 1.Form5 1. The drug is XR. Deferred for

2.Tablet 2.Routine 2. The firm has confirmation of me
3.Each extended 3. Rs.180/6s submitted an too status.
release tablet Rs.420/14s undertaking
contains: Rs.840/28s regarding
Amoxycillin as 4.22-07-2010 Comparative
trihydrate Dy.No.1380 dissolution profile.
...1 gm Form-5 3. Not found me
Clavulanic acid as Rs.8000/- too.
potassium 20-5-2013 FDA : Generic
62.5 mg Rs.12,000/- (Sandoz)
4.Antibiotic /
antibacterial for
microbial diseases
62. -do- 1.Rabosh 1.Form5 Me too status Deferred for
2.Injection 2.Routine confirmed confirmation of
3.Each vial 3. Rs.250/1s international
contains: 4.22-07-2010 Int. avail not availability.
Rabeprazole Dy.No.1387 confirmed in Str
Sodium..20 mg Rs.8000/- DRAs..
4.Gastric acid 20-5-2013
pump inhibitor Rs.12,000/-
63. M/s Indus 1.Irnazin 1.Form5 Me too status Approved

Pharma Pvt. Ltd. 2.Syrup 2.Routine confirmed.
Plot No.65, 3. Each ml 3. Rs23/30ml
Sector 27, contains: Rs44/60ml FDA : Xyzal
Korangi Levocetirizine Rs85/120ml
Industrial Area, dihydrochloride 4.13-08-2010
Karachi 0.5mg/ml Dy.No.1567
4.Antihistaminic Form-5
Rs.8000
09-5-2013
Rs.12,000/-
99
64. M/s Pfizer 1.Deltacortril 1.Form5 The firm has been Deferred for last
Laboratories Ltd. 2.Oral Suspension 2.Routine informed twice on reminder for
Plant. B-2, SITE, 3.Each 5ml 3. Rs.170/120ml telephone. Her submission of reply.
Karaci. contains: 4.30-7-2010 reply is still
Prednisolone Dy.No.1492 awaited
acetate.15 mg Rs.8,000/-
4.Corticosteroids 26-11-2012 FDA: Flo-pred
Rs.12,000/-
65. -do- 1.Viterra 1.Form5 The firm has been Deferred for last
Therapeutic 2.Routine informed twice on reminder for
2.Tablet 3. Rs.170/20s telephone. The submission of reply.
3.Each tablet 4.30-7-2010 reply is still
contains: Dy.No.1490 awaited
Vitamin A Rs.8,000/-
.5,000 IU 26-11-2012 Int. avail not
Vitamin Rs.12,000/- confirmed in Str
D..500 IU DRAs.
Thiamin
Mononitrate
...10 mg
Riboflavin
..10 mg
Pyridoxine HCl
.2 mg
Niacinamide
...100 mg
Calcium
Patothnate.5 mg
Vitamin B12
.5 mcg
Vitamin
C..150 mg
Calcium (from
calcium
carbonate). 50mg
Copper (From
Copper
Sulfate)..1 mg
Iodine (From
Potassium
Iodide)..0.15 mg
Iron (From Ferrous
Sulphate).10 mg
Magnesium (From
Magnesium
Sulfate) 5 mg
Manganese (From
manganese
sulfate)..1 mg
100
Molybdenum
(From Sodium
Molybdate)
.... 0.2 mg
Zinc (From Zinc
Sulfate).1.2mg
4.Vitamins &
Minerals
66. M/s Efroze 1.Ostrong 1.Form5 Already registered Approved
Chemical 2.Granules 2.Routine in sachet.
Industries Pvt. 3.Each granules 3. Rs.770/7s
Ltd. 146/23, contains: 4.30-7-2010 BNF: Protelos
Korangi Strontium Ranelate Dy.No.1493
Industrial Area, .2 gm Rs.8000/-
Karachi 4.Antiosteoporotic 21-5-2013
Rs.12,000/-
67. -do- 1.Roxin 1.Form5 Me too status Deferred for
2.Dry suspension 2.Routine confirmed. confirmation of
3.Each 5ml 3. Rs.175/60ml formulation of brand
contains: 4.20-7-2010 FDA: Ciproxin leader
Ciprofloxacin Dy.No.1357
.250 mg Rs.8000/-
4.Antibiotic 21-5-2013
Rs.12,000/-
68. M/s Zanctok 1.Form5 1. Reply has been Approved with
Pharmaceuticals 1.Mirtazip 2.Routine received. change in brand name
Laboratories, 2.Tablet 15mg 3. 20s,30s/ As per
Plot No.F-5-15 3.Each tablet PRC 1. Me too status
SITE, Area, contains: 4.23/07/2010 confirmed.
Hyderabad Mirtazapine Dy. No. 1412 FDA: Remeron
..15mg Rs. 8000/-
4.Anti depressant 13-5-2013
Rs.12,000/-
69. -do- 1.Form5 Me too status Approved
1.Genelor
2.Routine confirmed.
2.Tablet
3. 30s/As per PRC
3.Each tablet
4.23/07/2010 FDA: Clarinex
contains:
Dy. No. 1408
Desloratadine
Rs. 8000/-
...5mg
13-5-2013
4.Antihistamine
Rs.12,000/-
70. -do- 1.Form5 Me too status Deferred for
1.Vital-D 2.Routine needs confirmation confirmation of
2.Syrup 3. 60ml,120ml/As per international
3.Each 5ml PRC Int. avail not availability.
contains: 4.23/07/2010 confirmed in Str
Cholecalciferol Dy. No. 1414 DRAs.
...1000iu Rs. 8000/-
4.vitamin D 13-5-2013
Rs.12,000/-
101
71. -do- 1.Genelor 1.Form5 Me too as 2.5mg Deferred for
2.Syrup 2.Routine /5ml confirmation of me
3.Each 10ml 3. 60ml,120ml/As per FDA: Clarinex too status.
contains: PRC
Desloratadine 4.23/07/2010
.5mg Dy. No. 1411
4.Antihistamine Rs. 8000/-
13-5-2013
Rs.12,000/-
72. M/s The Searle 1.Beslol 1.Form5 Reply has been Approved
Company Ltd. 2.Tablet 2.Routine received.
Plot..F- 3.Each film coated 3. Rs.175/20s
319,SITE, tablet contains: 4.31-08-2010 2. Formulation is
Karachi Bisoprolol Dy.No.1625 Me too.
Fumarate..5mg Rs.8000/- 3. FDA: Zebeta
4.CSS/ Beta 13-5-2013
blocking agent Rs.12,000/-
Registration-III
73. M/s Paramount 1.Anepil 1.Form5 Me too confirmed Approved

Pharmaceuticals, 2.Capsule 2.Routine
36-Industrial 3.Each capsule 3.Rs.50/10s FDA: Generic
Triangle, Kahuta contains: 4.28-07-2010 (ACTAVIS
Road, Islamabad.
Gabapentin Rs.8000/- ELIZABETH)
100mg (Photo copy)
4.Gaba Analogue 14-05-2013
Rs.12,000/-
(Photo copy)
74. -do- 1.Velcard 1.Form5 Me too confirmed Approved
2.Tablet 2.Routine
3.Each tablet 3.Rs.527/14s FDA: Diovan
contains: 4.28-07-2010
Valsartan80mg Rs.8000/-
4.Angiotensin II (Photo copy)
receptor antagonist 14-05-2013
Rs.12,000/-
(Photo copy)
75. -do- 1.Cavir 1.Form5 Cavira of M/s Deferred for product
2.Tablet 2.Routine Brooks specific inspection by
3.Each film coated 3.Rs.7000/30s panel comprising of
tablet contains: 4.28-07-2010 FDA: Baraclude Director QA, DDG
Entecavir..0.5mg Rs.8000/- (E&M) and area FID.
4.Antiviral (Photo copy)
14-05-2013
Rs.12,000/-
(Photo copy)
102
76. -do- 1.Velcard 1.Form5 Me too confirmed Approved
2.Tablet 2.Routine FDA: Diovan
3.Each tablet 3.Rs.800/14s
contains: 4.28-07-2010
Valsartan.160mg Rs.8000/-
4.Angiotensin II (Photo copy)
receptor antagonist 14-05-2013
Rs.12,000/-
(Photo copy)
77. -do- 1.Cavir 1.Form5 Tacavair of M/s Deferred for product
2.Tablet 2.Routine Consolidated specific inspection by
3.Each film coated 3.Rs.14000/30s chemical Lab. panel comprising of
tablet contains: 4.28-07-2010 Director QA, DDG
Entecavir...1mg Rs.8000/- FDA: Baraclude (E&M) and area FID.
4.Antiviral (Photo copy)
14-05-2013
Rs.12,000/-
(Photo copy)
78. -do- 1.Anepil 1.Form5 Me too confirmed Approved
2.Capsule 2.Routine
3.Each capsule 3.Rs.200/10s FDA: Generic
contains: 4.28-07-2010 (ACTAVIS
400mg (Photo copy)
Rs.12,000/-
(Photo copy)
79. -do- 1.Anepil 1.Form5 Me too confirmed Approved
2.Capsule 2.Routine
3.Each capsule 3.Rs.150/10s FDA: Generic
contains: 4.28-07-2010 (ACTAVIS
300mg (Photo copy)
Rs.12,000/-
(Photo copy)
Registration-V
80. M/s Irza Pharma 1.Pasfon 1.Form5 The formulation is Deferred for review of
Pvt. Ltd. 10.2Km 2.Tablet 2.Routine already under formulation by review
Lahore, 3.Each tablet 3.50s/As per PRC review committee
Sheikhupura contains: 4.19-07-2010
Road Lahoreq Hydrated Rs.8000/-
pholoroglucinol..8 Rs.12,000/-
0 mg eq. to 17-05-2013
anhydrous
phloroglucinol6
2.233 mg
Trimethyphorogluc
103
inol80mg
4.pasfonmodic
81. -do- 1.Omotil 1.Form5 It is me too Deferred for
2.Tablet 2.Routine (Global) confirmation of
3.Each tablet 3.As per PRC strength of Atropine
contains: 4.19-07-2010 FDA : Colonaid Sulphate
Diphenoxylate Rs.8000/- (But arophine is
hydrochloride Rs.12,000/- 0.025mg per
.2.5mg 17-05-2013 tablet)
Atropine
Sulphate25mg
4.Opiate/
Anticholinergic
82. -do- 1.damotil 1.Form5 Me too confirmed Approved
2.Tablet 2.Routine
3.Each tablet 3.Rs.1000/Blister FDA: Generic
contains: pack (Sandoz)
Prochlorperazine 4.19-07-2010
maleate.5mg Rs.8000/-
4.Phenothiazine/ Rs.12,000/-
antiemetics 17-05-2013
83. -do- 1.Azirex 1.Form5 Me too confirmed Approved
2.Tablet 2.Routine
3.Each tablet 3.10s/As per PRC FDA : Zithromax
contains: 4.19-07-2010
Azithromycin Rs.8000/-
dehydrate eq. to Rs.12,000/-
Azithromycin 17-05-2013
..500 mg
4.Macrolide
84. M/s Allmed Pvt. 1.Uriflow D 1.Form5 Irrational Deferred for review of
Ltd. 2.Tablet 2.Routine formulation. M/s formulation by review
(Formerly, 3.Each tablet 3.As per PRC Global case is committee
EverGreen contains: 06-08-2010 already under
Pharmaceuticals, Tamsulosin Rs.8000/- consideration by
Pvt. Ltd. hydrochloride 11-10-2012 the Board.
Plot.No.590, 0.4mg Rs.12,000/-
Sundar Industrial Dutasteride FDA : Jalyn
Estate Lahore. .0.5 mg (Formulation
4.Intracellular method is
enzyme different)
85. M/s Genera 1.Sulpine 1.Form5 It is me too Approved
Pharmaceuticals, 2.Tablet 2.Routine (Fansidar of M/s
Plot. No.244, 3.Each tablet 3.As per PRC Roche)
Street.08, I-9/2, contains: 4.22-07-2010
Industrial Area, Sulfadoxine Rs.8000/- FDA: Fansidar
Islamabad 500mg 16-07-2013
Pyrimethamine Rs.12,000/-
25mg
4.Antimalarial
104
86. -do- 1.Epigen 1.Form5 Me too status Deferred for
2.Tablet 2.Routine confirmed confirmation of
3.Each tablet 3.As per PRC international
contains: 4.22-07-2010 Int. avail not availability in this salt
Sodium Rs.8000/- confirmed in Str form.
Valporate..250mg 16-07-2013 DRAs.
4.Anti epileptics, Rs.12,000/-
antimigraine
87. -do- 1.Epigen 1.Form5 Me too status Deferred for
2.Tablet 2.Routine confirmed confirmation of
3.Each tablet 3.As per PRC 2. 500 mg strength international
contains: 4.22-07-2010 is registered as availability in this salt
Sodium Rs.8000/- divalproic acid form.
Valporate 16-07-2013 Int. avail not
.500mg Rs.12,000/- confirmed in Str
4.Anti epileptics, DRAs.
antimigraine
88. -do- 1.Angirec 1.Form5 FDA: Cozaar Approved
2.Tablet 2.Routine
3.Each tablet 3.As per PRC Me too confirmed
contains: 4.22-07-2010
Losartan Rs.8000/-
potassium..50mg 16-07-2013
4.Anti Rs.12,000/-
hypertensives.
89. -do- 1.Angirec 1.Form5 FDA: Cozaar Approved
2.Tablet 2.Routine
3.Each tablet 3.As per PRC
contains: 4.22-07-2010 Me too confirmed
Losartan Rs.8000/-
potassium..25mg 16-07-2013
4.Anti Rs.12,000/-
hypertensives.
90. -do- 1.Clogril 1.Form5 FDA : Generic Approved
2.Tablet 2.Routine (Amneal Pharms)
Clopidogrel Rs.8000/-
.75mg 16-07-2013
4.Antiplatelet, Rs.12,000/-
aggregation
inhibitor
91. -do- 1.Clomipragen 1.Form5 Int. avail not Deferred for
2.Tablet 2.Routine confirmed in Str confirmation of
3.Each tablet 3.As per PRC DRAs. international
contains: 4.22-07-2010 availability.
Clomipramine Rs.8000/- Me too confirmed
hydrochloride 16-07-2013
.10 mg Rs.12,000/-
4.Antidepressant,
105
antiobsessional
92. -do- 1.Clomipragen 1.Form5 FDA: Anafranil Approved
2.Tablet 2.Routine
contains: 4.22-07-2010
Clomipramine Rs.8000/-
.75 mg Rs.12,000/-
4.Antidepressant,
antiobsessional
93. -do- 1.Clomipragen 1.Form5 FDA: Anafranil Approved
2.Tablet 2.Routine
contains: 4.22-07-2010
Clomipramine Rs.8000/-
.25 mg Rs.12,000/-
4.Antidepressant,
antiobsessional
94. -do- 1.Geniquin-P 1.Form5 Int. avail not Approved
2.Tablet 2.Routine confirmed in Str
3.Each tablet 3.As per PRC DRAs but
contains: 4.22-07-2010 formulation is
Primaquine Rs.8000/- recommended by
phosphate..7.5mg 16-07-2013 WHO.
4.Antimalarials Rs.12,000/-
Me too confirmed
95. -do- 1.Ciprogen 1.Form5 FDA: Cipro Approved
2.Tablet 2.Routine
Ciprofloxacin Rs.8000/-
.750mg 16-07-2013
4.Anti biotic Rs.12,000/-
96. M/s NovaMed 1.Oxycholine 1.Form5 Cercolin 500 mg Deferred for review of
Pharmaceuticals 2.Tablet 2.Routine Tab.(Schazoo). formulation by review
Pvt. Ltd. 28-Km, 3.Each tablet 3.As per SRO 2. The formulation committee.
Ferozepur Road, contains: 4.19-08-2010 is under review
Lahore
Citicoline.500mg Rs.8000/-
4.Psychotherapeuti 21-05-2013
c Rs.12,000/-
97. -do- 1.Oxytech 1.Form5 FDA: Arthrotec Deferred for product
2.Oral Tablet 2.Routine specific inspection by
3.Each tablet 3.As per SRO Confirmation of panel comprising of
contains: 4.19-08-2010 manufacturing Director DTL Lahore,
Diclofenac Rs.8000/- facility. DDG (E&M) and area
Sodium...50mg 21-05-2013 FID.
Misoprostol Rs.12,000/-
..200mg
4.Analgesic, anti-
106
inflammatory
98. -do- 1.Oxycholine 1.Form5 1. It is me too Deferred for review of

2.Oral Liquid 2.Routine 2. The formulation formulation by review
3.Each 5ml 3.As per SRO is already under committee.
contains: 4.19-08-2010 review.
Citicoline.500mg Rs.8000/-
4.Psychotherapeuti 21-05-2013
c Rs.12,000/-
99. M/s OBS Pakistan Co-Sinemet Tablet Form 5 Seineme Plus of Approved
Pvt. LTD. Each Tablet Routine M/s Muller &
C-14, Manghopir, contains: Rs.450/30s Phipps
Road, S.I.T.E, Carbidopa25 mg Rs.1400/100
Karachi.
Levodopa...100 mg Rs.8000/-
16-08 2010
(Anti-Parkinson) Rs.12000/-
14-05-2013
100. M/s Allmed Pvt. 1.Reevo 1.Form5 The firm had Deferred for
Ltd. 2.Tablet 2.Routine requested for confirmation of
(Formerly, 3.Each tablet 3.Rs.350/10s extension of time pharmacological
EverGreen contains: 4.06-08-2010
period for reply. group as applied by
Pharmaceuticals, Levocarnitine Rs.8000/-
Pvt. Ltd. .250mg 11-10-2012 firm.
Plot.No.590, 4.Aminoacid Rs.12,000/- Int. avail not
Sundar Industrial derivative/supplim confirmed in Str
Estate Lahore. ent DRAs in same
strength.
The firm has now

submitted the
replies,
101. -do- 1.Metoril 1.Form5 The firm had Deferred for
2.Tablet 2.Routine requested for confirmation of
3.Each tablet 3.100s/As per SRO extension of time international
contains: 4.06-08-2010 period for reply. availability and facilty
Nitrogen Rs.8000/-
Contents36mg 11-10-2012 for processing of
Calcium .0.5gm Rs.12,000/- Int. avail not nitrogen preparations
4.Aminoacids confirmed in Str
DRAs
The firm has now

submitted the
replies,
107
102. -do- 1.Reevo 1.Form5 The firm had Deferred for
2.Injection 2.Routine requested for confirmation of
3.Each ml 3.Rs.5mlx10s/ As extension of time pharmacological
contains: per SRO
period for reply. group as applied by
Levocarnitine 4.23-08-2010
..200 mg Rs.8000/- firm.
4.Anti infective 11-10-2012 FDA: Carnitor
systematic Rs.12,000/-
The firm has now
submitted the
replies,
103. M/s Epoch 1.Deemax 1.Form5 Reply is still Deferred for last
Pharmaceuticals 2.Tablet 2.Fast Track awaited reminder provision of
Plot.No.83,85, 3.Each tablet3. Rs.300/30s international
Sector 15, contains: Rs.600/60s Int. avail not availability
Korangi Cholecaliciferol 4.7-05-2013 confirmed in Str
Industrail Area, (Vitamin Dy.No.287 DRAs
Karachi D3)..5000 IU Form-5
4.Vitamins Rs.20,000/-
14-5-2013
Rs.40,000/-
104. -do- 1.Deemax 1.Form5 Reply isstill Deferred for last
2.Injection 2.Fast Track awaited reminder provision of
3.Each 1ml 3. Rs.165/1Ampule international
contains: 4.7-05-2013 Int. avail not availability
Cholecaliciferol Dy.No.290 confirmed in Str
(Vitamin Rs.20,000/- DRAs
D3)200,000 IU 14-5-2013
2.Syrup 2.Fast Track awaited reminder provision of
3.Each 10ml 3. Rs.120/120ml international
D3)1000 IU 14-5-2013
2.Drops 2.Fast Track awaited reminder provision of
3.Each ml 3. Rs.600/10ml international
D3)1000 IU 14-5-2013
108
107. M/s Getz 1.Zetro 1.FormD Reply is still Deferred for last
Pharma (Pvt) 2.Oral Suspension 2.Routine awaited reminder provision of
Limited 29,30, 3.Each 60 ml 3. Rs.500/60ml international
Sector-27, contains: 4.30-7-2010 Int. avail not availability
Korangi Azithromycin Dy.No.1494 confirmed in Str
Industrial Area, dehydrate eq. to Rs.15000/- DRAs in same
Karachi-74900 Azithromycin 13-5-2013 strength
.2 gm Rs.35,000/-
4.Macrolides-
Antibiotics
Case No.03. Registration applications of New License.
Evaluator- IV
109
S/N Name and Brand Name Type of Form Remarks on the Decision
address of (Proprietary name formulation (if any)
manufacturer/ + Dosage Form + Initial date, diary including International
Applicant Strength) status in stringent drug
Fee including regulatory agencies /
Composition differential fee authorities
Pharmacological Demanded Price / Me-too status

Group Pack size
GMP status as depicted
Finished product in latest inspection
Specification report (with date) by the
Evaluator
108. M/s Umema Umexon Tablet 250 Form 5 International : Levaquine Approved
Pharma mg 01-11-2013 Tablet 250 mg approved
Plot No. M-28, Each film coated Rs. 20,000 by FDA
Hub Industrial tablet contains Local: Atcoflox Tablet
Estate, Levofloxacin as Rs 39.5/ Tablet 250 mg by M/s Atco
Balochistan hemi hydrate 1 10 According to report of
250 mg inspection conducted on
New License 19th September, 2013,
Tablet (General) (Antibiotic) panel recommended grant
Capsule Finished product of DML by way of
(General) specifications are formulation.
Manufacturer.
109. M/s Umema Umexon Tablet 500 Form 5 International : Levaquine Approved
Pharma mg 01-11-2013 Tablet 500 mg approved
Plot No. M-28, Each film coated Rs. 20,000 by FDA
Hub Industrial tablet contains Local: Atcoflox Tablet
Estate, Levofloxacin as Rs 80/ Tablet 500 mg by M/s Atco
Balochistan hemi hydrate 1 10 According to report of
19th September, 2013,
(Antibiotic) panel recommended grant
Finished product of DML by way of
specifications are formulation.
Manufacturer.
110. M/s Umema MF- 500 Tablet Form 5 International: Ponston Deferred for
Pharma Each film coated 10-02-2014 Forte Tablet 500 mg in clarification
Plot No. M-28, tablet contains Rs. 20,000 UK whether the
Hub Industrial Mefenamic acid Local: Ponstan Forte 500 formulation is
Estate, EP.500 mg Rs 1.65 / Tablet mg Tablet by M/s Pfizer film coated or
Balochistan (NSAID) 10 10 otherwise.
Finished product According to report of
specifications are inspection conducted on
BP. 19th September, 2013, 110
panel recommended grant
of DML by way of
formulation
111. M/s Umema MF- 500 Tablet Form 5 International: Mefenamic Deferred for
Pharma Each film coated 31-10-2013 acid tablet 250 mg not clarification
Plot No. M-28, tablet contains Rs. 20,000 available in SRAs. Meface whether the
Hub Industrial Mefenamic acid Tablet 250 mg and formulation is
Estate, EP.250 mg Rs 0.984 / Tablet Mefacid Tablet 250 mg film coated or
Balochistan (NSAID) 10 10 available in India. otherwise.
Local: Ponstan 500 mg
Finished product Tablet by M/s Pfizer
specifications are According to report of
BP. inspection conducted on
of DML by way of
formulation.
112. M/s Umema Ciprokit 250 Tablet Form 5 International: Cipro Tablet Approved.
Pharma Ciprofloxacin as 10-02-2014 250 mg approve by FDA
Plot No. M-28, HCL USP eq to Rs. 20,000 Local: Algocin Tablet 250
Hub Industrial Ciprofloxacin mg by M/s AGP
Estate, ....250mg Rs 21 / Tablet According to report of
Balochistan 1 10 inspection conducted on
(Quinolone) 19th September, 2013,
Finished Product panel recommended grant
specifications are of DML by way of
USP. formulation.
113. M/s Umema Allergic tablet 10 Form 5 International: Cetirizine Approved with
Pharma mg 21-02-2014 Hydrochloride Allergy 10 change of
Plot No. M-28, Each film coated Rs. 20,000 mg approved by FDA brand name.
Hub Industrial tablet contains Local: Alergo 10 mg by
Estate, Cetirizine HCL Rs 4.5 / Tablet M/s Pharmix
Balochistan BP10 mg 10s, 20s According to report of
inspection conducted on
(Antihistamine) 19th September, 2013,
Finished product
specifications are
BP. of DML by way of
formulation.
114. M/s Umema Col- Dine 20 m g Form 5 International: Famotidine Approved with
Pharma Tablet 31-10-2013 Tablet 20 mg (FDA) change in
Plot No. M-28, Each film coated Rs. 20,000 Local: Amotidie tablet 20 brand name.
Hub Industrial tablet contains mg by M/s Genix Pharma
Estate, Famotidine Rs 10 / Tablet According to report of
Balochistan BP20 mg 10s, 20s inspection conducted on
(Antihistamine) 19th September, 2013,
111
BP.
115. M/s Umema Toomema 50 mg Form 5 International: Tenormin Approved.
Pharma Tablet 21-02-2014 Tablet 50 mg
Plot No. M-28, Each tablet contains Rs. 20,000 Local: Atelor 50 mg tablet
Hub Industrial Atenolol BP50 by M/s Pharmedic
Estate, mg Rs 6.10 / Tablet According to report of
Balochistan (Antihypertensive, 14s, 20s, 30s inspection conducted on
1 adrenergic 19th September, 2013,
blocker) panel recommended grant
BP.
116. M/s Umema Montkast Tablets 10 Form 5 International: Singulair Approved.
Pharma mg 31-10-2013 Tablet 10 mg (FDA)
Plot No. M-28, Each film coated Rs. 20,000 Local: Aerokast 10 mg by
Hub Industrial tablet contains M/s Barret Hidgson
Estate, Montelukast Sodium Rs 24.45/ Tablet According to report of
Balochistan eq to Montelukast 10s, 14s inspection conducted on
BP..10 mg 19th September, 2013,
(Leukotriene
Receptor
of DML by way of
Antagonist) formulation.
Finished product
specifications are
Manufacturer
117. M/s Umema Dicum 50 mg tablet Form 5 International: Voltaren Approved.

Pharma Each enteric coated 31-10-2013 Delayed Release Tablet 50
Plot No. M-28, tablet contains Rs. 20,000 mg
Hub Industrial Diclofenac Sodium Local: Alfafenac 50 mg
Estate, BP.50 mg Rs 5.04 / Tablet tablet by M/s Alfalah
Balochistan (NSAID) According to report of
inspection conducted on
Finished product 19th September, 2013,
specifications are
BP.
of DML by way of
formulation.
118. M/s Umema Azoum Capsules Form 5 International: Zithromycin Approved.

Pharma 250 mg 10-02-2014 250 mg Capsule
Plot No. M-28, Each capsule Rs. 20,000 Local: Azicure 250 mg
Hub Industrial contains Capsule by M/s Semos
Estate, Azithromycin As per PRC According to report of
Balochistan dihydrate USP eq to inspection conducted on
112
Azithromycin .. 19th September, 2013,
250 mg panel recommended grant
(Macrolide of DML by way of
Antibiotic) formulation.
Finished product
specifications are
USP.
119. M/s Umema Azoum Capsules Form 5 International: Deferred for
Pharma 500 mg 10-02-2014 Azithromycin 500 mg confirmation of
Plot No. M-28, Each capsule Rs. 20,000 Capsule not approved by international
Hub Industrial contains reference DRAs availability in
Estate, Azithromycin As per PRC Local: Azicure 500 mg Stringent
Balochistan dihydrate USP eq to Capsule by M/s Semos Regulatory
Azithromycin .. According to report of Agencies.
(Macrolide 19th September, 2013,
Antibiotic)
USP.
120. M/s Umema Celecap 200 mg Form 5 International: Celebrex Approved.
Pharma Capsule 10-02-2014 Capsule 200 mg (FDA)
Plot No. M-28, Each capsule Rs. 20,000 Local: Bixo Capsule 200
Hub Industrial contains mg by M/s Vega
Estate, Celecoxib As per PRC According to report of
Balochistan USP.200 mg inspection conducted on
(Cox-2 Inhibitor)
Finished product
specifications are of DML by way of
Manufacturer. formulation.
121. M/s Umema Umepro 200 mg Form 5 International: Naproxen Deferred since
Pharma Capsule 10-02-2014 Sodium 200 mg Capsule the formulation
Plot No. M-28, Each capsule Rs. 20,000 Local: Napreben 250 mg is in liquid
Hub Industrial contains Capsule by M/s Pacific filled capsule
Estate, Naproxen Sodium As per PRC in Stringent
Balochistan BP eq to According to report of Regulatory
inspection conducted on Agencies.
Naproxen.200 19th September, 2013,
mg panel recommended grant
of DML by way of
(NSAID) Finished
formulation.
product
specifications are
Manufacturer.
113
122. M/s Umema Do-Cycline 100 mg Form 5 International: Vibramycin Approved.
Pharma Capsule 10-02-2014 200 mg Capsule
Plot No. M-28, Each capsule Rs. 20,000 Local: Doxinom 100 mg
Hub Industrial contains Capsul by M/s Genom
Estate, Doxycycline As per PRC According to report of
Balochistan Hyclate BP eq to inspection conducted on
Doxycycline 100 mg 19th September, 2013,
(Antibiotic) of DML by way of
Finished product formulation.
specifications are
BP.
123. M/s Umema Eso-40 mg Capsule Form 5 International: Nexium Approved.

Pharma Each capsule 31-10-2013 Capsule 40 mg
Plot No. M-28, contains Rs. 20,000 Local: Acireg Capsule
Hub Industrial Enteric coated 40mg
Estate, pellets (22.5%) of As per PRC According to report of
Balochistan Esomeprazole inspection conducted on
Source of Pellets Magnesium 19th September, 2013,
M/s Vision Trihydrate40
Pharmaceuticals. mg
Plot No. 224, (Proton pump of DML by way of
Street No. 1, I- inhibitor) formulation.
10/3, Industrial
Area, Islamabad. Finished Product
Specifications are
Manufacturer.
124. M/s Umema Eso-20 mg Capsule Form 5 International: Nexium Approved.
Plot No. M-28, contains Rs. 20,000 Local: Acireg Capsule
Hub Industrial Enteric coated 20mg
Balochistan Esomeprazole inspection conducted on
Source of Pellets Magnesium 19th September, 2013,
M/s Vision Trihydrate20
Pharmaceuticals. mg
of DML by way of
Plot No. 224, (Proton pump
inhibitor) formulation.
Street No. 1, I-
10/3, Industrial
Area, Islamabad. Finished Product
Specifications are
Manufacturer.
125. M/s Umema Ome-40 mg Capsule Form 5 International: Prilosec Approved.

Plot No. M-28, contains Rs. 20,000 Local: Zoglit Capsule 40
114
Hub Industrial Enteric coated mg
Balochistan Omeprazole 40 inspection conducted on
Source of Pellets mg 19th September, 2013,
M/s Vision (Proton pump
Pharmaceuticals. inhibitor)
Plot No. 224, of DML by way of
Finished Product formulation.
Street No. 1, I-
10/3, Industrial Specifications are
Area, Islamabad. USP.
126. M/s Umema Ome-20 mg Capsule Form 5 International: Prilosec Approved.

Plot No. M-28, contains Rs. 20,000 Local: Zoglit Capsule 20
Hub Industrial Enteric coated mg
Balochistan Omeprazole 20 inspection conducted on
Source of Pellets mg 19th September, 2013,
M/s Vision (Proton pump panel recommended grant
Pharmaceuticals. inhibitor) of DML by way of
Plot No. 224, formulation.
Street No. 1, I- Finished Product
10/3, Industrial Specifications are
Area, Islamabad. USP.
127. M/s Ashraf Ashraf Absorbent Form 5 International: Surgical Approved.

Surgical Cotton Cotton BP 28-04-2014 absorbent (BNF)
& Bandages, Rs 20,000 Local: Absorbent cotton
Chak No. 5/4-1, Contains As per SRO wool by M/s S.Fazalilahi
By Pass, Okara Carded cotton fibres & sons
New license of not less than 10 According to report
1. Cotton wool mm average staple attached, firm was
2. Bandage Type length inspected on 18-02-2014
II for grant of DML
3. Crepe Bandage (Cellulose)
Specifications are
BP
128. M/s Ashraf Ashraf cotton crepe Form 5 International: Cotton Approved.
Surgical Cotton Bandage BP 28-04-2014 Crepe Bandage (BNF)
& Bandages, Rs 20,000 Local: Mashaal Cotton
Chak No. 5/4-1, Contains As per SRO Crepe Bandage by M/s Ali
By Pass, Okara Cotton 100% noor Industries
New license (Support Bandage) According to report
1. Cotton wool Specifications are attached, firm was
2. Bandage Type BP inspected on 18-02-2014
II for grant of DML
3. Crepe Bandage
129. M/s Ashraf Ashraf cotton Form 5 International: Bandage BP Approved.
Surgical Cotton Bandage BP type II 28-04-2014 Type II
115
& Bandages, Rs 20,000 Local: Cotton Bandage BP
Chak No. 5/4-1, Contains: As per SRO Type II by M/s The
By Pass, Okara Cotton National Cotton Mill
New license (Support Bandage) According to report
1. Cotton wool Specifications are attached, firm was
2. Bandage Type BP inspected on 18-02-2014
II for grant of DML
3. Crepe Bandage
Case No.04. Registration Applications of New / Additional sections.
Evaluator III
address of (Proprietary name formulation (if
manufacturer / + Dosage Form Initial date, any) including
Applicant + Strength) diary International
status in
Composition Fee including stringent drug
differential regulatory
Pharmacological fee agencies /
Group authorities
Demanded Price
Finished product / Pack size Me-too status
Specification
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
130. M/s King Moxip Tablet 400mg Form-5 AVELOX

Pharmaceuticals, (moxifloxacin Approved.
27- Sunder Each film coated tablet 28/03/14 Dy hydrochloride)
Industrial Estate, contains Moxifloxacin No.577 tablet, film
Raiwind Road, as coated (Bayer
Lahore. Hydrochloride400mg Rs.20,000/- Schering Inc).
(Tablet General) Fluoroquiolones Rs.475/ pack of Avelox of Bayer

5s Healthcare
Manufacturer Karachi.
Inspection of the
firm was
conducted on 19-
02-2014 by the
panel of
inspectors and
recommended the
116
grant of tablet
section.
131. -do- Xerox Tablets 20mg Form-5 Brexidol of Approved with

Chiesi change in brand
Each tablet contains 28/03/14 Dy name.
Piroxicam Beta No.583 Exican of Nova
Cyclodextrin equivalent to Med Lahore
Piroxicam..20mg Rs.20,000/-
NSAID Rs.200/- Pack of

20s
Manufacture
132. -do- Z-Max Tablet 250mg Form-5 Azithromycin Approved.

Dihydrate of
Each film coated tablet 28/03/14 Dy Apotex Corp
contains Azithromycin as No.580
dihydrate...250mg Azitor of Macter
Rs.20,000/- Int Pvt Limited
Macrolide Karachi
Rs.255/- Pack of
Manufacturer 10s
133. -do- Advin Tablets 250mg Form-5 Tavanic of Sanofi Approved.

Aventis
Each tablet contains 28/03/14 Dy
Levofloxacin as No.584 Leflox of Getz
hemihydarte...250mg Karachi
Rs.20,000/-
Fluoroquinolone
Antibacterial Rs.150/- Pack of
10s
Manufacturer
134. -do- Advin Tablets 500mg Form-5 Tavanic of Sanofi Approved.
Aventis
Each tablet contains 28/03/14 Dy
Levofloxacin as No.587 Leflox of Getz
hemihydarte...500mg Karachi
Rs.20,000/-
Fluoroquinolone
10s
Manufacturer
117
135. -do- Vipro Tablet 250mg Form-5 Ciproxin of Approved.
Bayer Schering
Each film coated tablet 28/03/14 Dy (BNF)
contains Ciprofloxacin as No.586
hydrochloride..250mg Ciproxin of
Rs.20,000/- Bayer Healthcare
Fluoroquinolone Karachi
10s
BP
136. -do- Vipro Tablet 500mg Form-5 Ciproxin of Approved.

Bayer Schering
Each film coated tablet 28/03/14 Dy (BNF)
contains Ciprofloxacin as No.576
hydrochloride..500mg Ciproxin of
Rs.20,000/- Bayer Healthcare
Fluoroquinolone Karachi
10s
BP
137. -do- Martin Tablet 10mg Form-5 Singulair of MSD Approved with
change in brand
Each film coated tablet 28/03/14 Dy Bronsecur of name.
contains Montelukast as No.579 Pfizer Karachi
sodium.10mg
Rs.20,000/-
Leukotriene antagonist
Rs.310/- pack of
Manufacturer 14s
138. -do- Vivan Tablet Form-5 Not found in Deferred for

stringent DRAs review of
Each enteric coated tablet 28/03/14 Dy like FDA, TGA, formulation by
contains:- No.585 EMA, MHLW review
Esomeprazole..40mg and Health committee.
Domperidone..30mg Rs.20,000/- Canada.
PPI + antidopaminergic As per SRO/ Dignity Tablets

pack of 14s of Everest
Manufacturer Pharma
Islamabad
072203
API and Finished

product
specifications are
not submitted
118
139. -do- Pride Tablet 50mg Form-5 Not found in Deferred for
stringent DRAs review of
Each tablet contains 28/03/14 Dy like FDA, TGA, formulation by
Itopride as HCl 50mg. No.581 EMA, MHLW review
and Health committee.
Gastroprokinetic/ Rs.20,000/- Canada.
antiemetic
Rs.400/- pack of Ganaton of
Manufacturer 10s Abbott Labs
Karachi.
Formulation is
under review.
Finished product
specifications are
required
140. M/s Wenovo Ceprin Injection 250mg Form 5 Ceftriaxone of Approved.
Pharmaceuticals, (IM) Apotex Corp
Plot No 31, 32, Dy No. 524 dated
Punjab Each vial contains 03/06/2014 Cefcin of Cirin
Industrial Estate, Ceftriaxone Sodium USP Pharmaceuticals
Rs.20,000/- Hattar
Taxila, equivalent to
Ceftriaxone.. 250mg
Rawalpindi. Pack of 1s with Inspection of the
Antibiotic, Cephalosporin 2ml of Lidocaine firm was
for Injection/ As conducted on 14-
USP per SRO 05-14 by the
(Dry Powder
panel of
Injection inspectors and
Cephalosporin) recommended the
grant of
additional
sections namely,
Dry powder
injection
(cephalosporin),
Oral dry powder
suspension
(cephalosporin),
Dry powder
sachet
(cephalosporin),
Dry powder vial
injectable
(general) and
Liquid ampoule
general (SVP)
119
141. -do- Ceprin Injection 500mg Form 5 Ceftriaxone of Approved
(IM) Apotex Corp
Dy No. 523 dated
Each vial contains 03/06/2014 Cefcin of Cirin
Ceftriaxone Sodium USP Pharmaceuticals
equivalent to Rs.20,000/- Hattar
Ceftriaxone.. 500mg
Pack of 1s with
Antibiotic, Cephalosporin 2ml of Lidocaine
for Injection/ As
USP per SRO
142. -do- Ceprin Injection 1g (IM) Form 5 Ceftriaxone of Approved

Apotex Corp
Each vial contains Dy No. 522 dated
Ceftriaxone Sodium USP 03/06/2014 Cefcin of Cirin
equivalent to Pharmaceuticals
Ceftriaxone.. 1g Rs.20,000/- Hattar
Antibiotic, Cephalosporin Pack of 1s with

2ml of Lidocaine
USP for Injection/ As
per SRO
143. -do- Cefip Injection 500mg Form 5 Maxipime of Approved.

Hospira Inc
Cefepime Hydrochloride 03/06/2014
with L-arginine USP
equivalent to Rs.20,000/- Maxipime of
Cefepime.500mg GSK
Pack of 1s and
Antibiotic, cephalosporin 1s ampoule of
water for
USP injection./ As per
SRO
120
144. -do- Cefip Injection 1g Form 5 Maxipime of Approved.
Hospira Inc
Cefepime Hydrochloride 03/06/2014 Maxipime of
with L-arginine USP GSK
equivalent to Rs.20,000/-
Cefepime.1g
Pack of 1s and
Antibiotic, cephalosporin 1s ampoule of
water for
USP injection./ As per
SRO
145. -do- Novozon Injection 1gm Form 5 Not found in Approved.

stringent
Each vial contains Dy No. 528 dated regulatory
Cefoperazone Sodium 03/06/2014 agencies.
equivalent to
Cefoperazone.500mg + Rs.20,000/- Winbact of
Sulbactum Sodium Wnsfileld
Pack of 1s and
equivalent to Pharmaceuticals
1s ampoule of
Sulbactum..500mg Hattar
water for
Antibiotic, Cephalosporin injection./ As per
SRO
and Beta lactamase
inhibitor
Manufacturer
146. -do- Novozon Injection 2gm Form 5 Not found in Approved.

stringent
Each vial contains Dy No. 527 dated regulatory
Cefoperazone Sodium 03/06/2014 agencies.
equivalent to
Cefoperazone.1g + Rs.20,000/- Winbact of
Sulbactum Sodium Wnsfileld
Pack of 1s and
equivalent to 1s ampoule of Pharmaceuticals
Sulbactum..1g Hattar.
water for
Antibiotic, Cephalosporin injection./ As per
and Beta lactamase SRO
inhibitor
Manufacturer
121
147. -do- Wenomet Injection Form 5 Applied product Approved.
80mg/ml is found in
(Liquid Dy No. 531 dated stringent
Ampoule SVP Each ampoule contains 03/06/2014
regulatory
General) Artemether80mg/ml agecies however
Rs.20,000/-
Anti- malarial the firm has
As per SRO submitted the
Manufacturer reference of
Artim injection
of Kunming
Pharma China
Artem of Hilton
Pharma Karachi
148. -do- Wink Injection Form 5 Applied product Deferred for final
is not found in reminder for
Each ml contains Iron Dy No. 531 dated stringent provision of
Isomaltoside equivalent to 03/06/2014
regulatory evidence of
elemental iron.100mg/ml agenceis. availability of
Rs.20,000/-
TOC analyzer.
Iron deficiency anemia Wisofer of
As per SRO/
Manufacturer Wellmark
Pack of 5s Pharmaceuticals
Hattar
Evidence of
availability of
TOC analyzer
has not been
provided
149. -do- Novoket Injection Form 5 Toradol of Roche Deferred for final
reminder for
Eachml contains Ketorolac Dy No. 541 dated Torapan of provision of
Tromethamole equivalent 03/06/2014 Caraway evidence of
to Ketorolac.. Pharmaceuticals availability of
30mg/ml Rs.20,000/- Islamabad. TOC analyzer.
NSAID As per SRO/
Evidence of
Pack of1m x 5s availability of
USP TOC analyzer
has not been
provided
122
150. -do- Novobal Injection Form 5 Applied product Deferred for final
is not found in reminder for
Each ml contains Dy No. 537 dated stringent provision of
Mecobalamin.500mcg/ 03/06/2014
regulatory evidence of
ml agencies. availability of
Rs.20,000/-
TOC analyzer.
Vitamin B-12 Neuromet of
As per SRO/
Merck Karachi
Manufacturer
Pack of 1ml
x10s Evidence of
availability of
TOC analyzer
has not been
provided
151. -do- D-3 Wink Injection Form 5 Applied product Approved.

is not found in
Each ml of ampoule Dy No. 538 dated stringent
contains Cholecalciferol 03/06/2014 regulatory
200,000IU equivalent to agencies.
5mg Cholecalciferol. Rs.20,000/-
As per SRO/ Indrop-D of

Vitamin Neutro Pharma,
Pack of 1ml x1s Lahore.
Manufacturer
and 5
152. -do- Novofer Injection Form 5 Venofer of

Deferred for final
Fresenius reminder for
Each ml contains Iron Dy No. 536 dated Medical care provision of
Sucrose equivalent to 03/06/2014 evidence of
Elemental Iron.20mg Bisleri of Sami availability
Rs.20,000/- of
Pharma Karchi TOC analyzer.
Antianemic
As per SRO/ Evidence of
Manufacturer availability of
Pack of 5ml x 5s
TOC analyzer
has not been
provided
123
153. -do- Wenowater Injection 5ml Form 5 Wellwater of Deferred for final
Welwrd reminder for
Each ampoule contains Dy No. 536 dated Pharmaceuticals provision of
Water for Injection.5ml 03/06/2014 Hattar evidence of
USP 20,000/- availability of
Evidence of TOC analyzer.
As per SRO availability of
TOC analyzer
has not been
provided
154. -do- Danvo Injection 8mg/4ml Form 5 Zofran of Deferred for final
GSK (BNF- reminder for
Each 4ml contains Dy No. 532 dated 61) provision of
Ondansetron as 03/06/2014 evidence of
Hydrochloride..8mg Zofran GSK,
20,000/- availability of
Karachi TOC analyzer.
5HT3 receptor antagonist
As per SRO Evidence of
USP availability of
TOC analyzer
has not been
provided
M/s Hiranis Pharmaceuticals Karachi has submitted new registration applications in lieu of their products
which are deferred/ rejected in the 243rd meeting of Registration Board. The detail is as under:
Sr Product discussed in M- Decision in M-243 New product applied

No 243
1 Gastopride Tablet Referred to review committee for Nomigra Tablet (Sumatriptan
(Cinitapride as acid review of formulation Succinate eq. to
tartrate) Sumatriptan..85mg)
2 Tofastib tablet Deferred for following reasons:- Arti-Q Tablets
(Tofacitinib) 1.Firm has no separate facility for (Dihydroartemisinin
manufacturing of 40mg +Piperaquine
immunosuppressant products) Phosphate 320mg
3 Acebro Capsules Rejected as safety and efficacy of Fungisaf Capsules
(Acebrophylline 100mg) formulation has not been (Fluconazole 150mg)
established in stringent regulatory
authorities
4 Aclidum Capsules Deferred for PSI and international Erdozet Capsule (Erdosteine
(Aclinidum bromide availability status in capsule dosage 150mg)
400mg) form
5 Dilast Capsule Deferred for confirmation of Ace Capsule (Acetretin
(Ibudilast 10mg) indication 25mg)
124
6 Gastopride Syrup Deferred for review of formulation Zargus Oral Solution
(Cinitapride as acid (Resperidone 5mg/ 5ml)
tartrate 1mg/5ml)
7 Acebro syrup Rejected as safety and efficacy of Recita Oral Solution
(Acebrophylline 50mg/ formulation has not been (Escitalopram Oxalate
5ml) established in stringent regulatory equivalent to Escitalopram
authorities 10mg)
The Evaluation Report of above mentioned newly applied products is detailed below:
Decision: The request of the firm has been deferred till final decision on deferred cases of applicant.
S/N Name and Brand Name Type of Remarks on the

address of (Proprietary name + Form formulation (if any)
manufacturer / Dosage Form + including International
Applicant Strength) Initial date, status in stringent drug
diary regulatory agencies /
Composition authorities
Fee
Pharmacological including Me-too status
Group differential
fee GMP status as depicted in
Finished product latest inspection report
Specification Demanded (with date) by the Evaluator
Price / Pack
size
155. M/s Hiranis Nomigra Tablet Form-5 Trexime GSK USA
Pharmaceuticals
(Pvt), Limited, Each film coated tablet Dy No: 223 Sumig Plus of Hilton Pharma
Plot No E-145 contains dated 09-10- Karachi
to 149, North Sumatriptan Succinate 13
Western, eq. to Inspection of the firm was
Industrial Zone, Sumatriptan..85mg 20,000/- conducted by the panel of
Port Qasim, inspectors on 23-09-2013
Karachi Naproxen As per PRC/ and recommended the grant
Sodium.500mg Pack of 2s, of DML.
6s & 10s
5-HT1 agonist + NSAID
Manufacturer
125
156. -do- Arti-Q Tablets Form-5 Eurartisem of Stigma Tau
UK
Each film coated tablet Dy No: 473
contains dated 26-11- Diphos of Genix Pharma
Dihydroartemisinin.. 13 Karachi
40mg
Piperaquine 20,000/-
Phosphate..320mg
As per PRC
Anti-malarial
Manufacturer
157. -do- Fungisaf Capsule Form-5 Diflucan Pfizer Inc

150mg
Dy No: 807 Diflucan of Pfizer Karachi
Each capsule contains dated 28-07-
Fluconazole..150mg 14
Triazole Antifungal 20,000/-
Manufacturer As per PRC
158. -do- Erdozet Capsule Form-5 Erdotin Capsule of Edmond

150mg Pharma, Italy
Dy No: 473
Each capsule contains dated 26-11- Dostin of Brookes
Erdosteine..150mg 13 Pharmaceuticals Karachi
Fludifying Agent 20,000/-
Manufacturer As per PRC

159. -do- Ace Capsules 25mg Form-5 Soriatane of Stiefel Labs Inc
Each capsule contains Dy No: 90 Neotigason of Roche

Acetretin..25mg dated 06-02- Karachi
14
Antipsoriasis
20,000/-
BP
As per PRC
160. -do- Zargus Oral Solution Form-5 Risperdal of Janssen- Cilag
5mg/5ml Inc
Dy No: 505
Each 5ml of solution dated 06-12- Risperdal of Janssen- Cilag
contains 13
Resperidone.5mg
20,000/-
Atypical Antipsychotic
As per PRC
126
Manufacturer
161. Recita Oral Solution Form-5 Lexapro Oral Solution of

Forest Inc
Each ml contains Dy No: 506
Escitalopram Oxalate dated 05-12- Prolexa Oral Solution of M/s
equivalent to 13 Reko Pharma, Lahore.
Escitalopram10mg
20,000/-
SSRI
As per PRC/
Manufacturer Pack of 1s
Bottle of
30ml
Evaluator V
Sr. Name and Brand Name Type of Form Remarks on the Decision
No. address of (Proprietary name + formulation (if any)
Manufacturer / Dosage form + Initial date, diary including International
Applicant Strength) status in stringent
Pharmacological Demanded Price Me-too status

Group / Pack size
GMP status as
Finished product depicted in inspection
specification report (dated)
162. M/s. Hamaz Lyoflor 250mg Form-5 To be referred to HOTC Referred to H&OTC
Pharmaceuticals sachet division Division.
(Pvt) Ltd, 11-KM 18-2-2014
Lutafabad Road Sachet 624 R&I Inspection for renewal
Multan. of DML and grant of
Each sachet contains:- Rs.20,000/- new sections conducted
Additional Saccharomyces on 23/02/2013
Section: boulardii Rs.480.00 / 10s
Sachet section (lyophilized)..250m sachet
(non antibiotics) g
Vide letter No. F.
6-1/2013 Lic Anti-diarrhoeal
(M-232) microorganisms
Specifications
163. -do- D-Mecta 3g sachet Form-5 1. Evidence of approval Deferred for review of
of same formulation in formulation by review
Sachet 18-2-2014 same strength and committee
Each sachet contains:- 623 R&I dosage form as approved
Dioctahedral by a stringent regulatory
smectite.3g Rs.20,000/- agency (e.g., US FDA,
127
TGA, EMA, Health
Anti-diarrheal Rs.420.00/30s Canada or MHLW)
sachet required.
2. Evidence of approval
of technical staff from
licensing section.
3. Assay method is
ambiguous / incomplete.
of Q.C staff by
Licensing.
5. Address of
manufacturer has been
mentioned as 11 km,
Lutfabad Road Multan
in the approval letter
from Licensing division
whereas, 13km,
Lutfabad Road, Multan
has been mentioned in
the dossier. The firm has
informed that it was
mistakenly written as
11Km while the actual
distance is 13km,
Lutfabad Bosan Road,
Multan.
Firm has mentioned

following international
reference:
SMECTA
Pharma Plan
South Africa
SMECTA
3g
Atco
164. -do- Colyte sachet Form-5 1. Evidence of approval Approved. Firm will
of technical staff from provide approval of
Sachet 18-2-2014 licensing section. technical staff and
622 R&I 2. Evidence of approval Chairman RB will
Each sachet contains:- of Q.C staff by approve issuance of
Polyethylene glycol Rs.20,000/- Licensing. letter
.. 3. Address of
13.125gm Rs.225.00/10s manufacturer has been
Sodium bicarbonate sachet mentioned as 11 km,
... Lutfabad Road Multan
178.5mg in the approval letter
128
Sodium chloride from Licensing division
... whereas, 13km,
350.7mg Lutfabad Road, Multan
Potassium chloride has been mentioned in
. the dossier. The firm has
46.6mg informed that it was
Osmotic laxative 11Km while the actual
distance is 13km,
Multan.
LAXIDO Orange
Powder for oral solution
BNF
MOVCOL Sachet
Genix
165. -do- Bio calcin Plus sachet Form-5 1. Evidence of approval Deferred for product
of technical staff from specific inspection by
Sachet 18-2-2014 licensing section. panel comprising of
621 R&I 2. Evidence of approval Director DTL Lahore,
Each sachet contains:-
Calcium lactate
of Q.C staff by DDG (E&M) and area
Gluconate Rs.20,000/- Licensing. FID
.. 3. Address of
1000mg Rs.96.00/10s manufacturer has been
Calcium carbonate sachet mentioned as 11 km,
327mg in the approval letter
Vitamin C .. 500 from Licensing division
mg whereas, 13km,
Folic acid Lutfabad Road, Multan
1mg
B12 ...
250mcg the dossier. The firm has
Calcium supplement mistakenly written as
distance is 13km,
Multan.
MULTICAL
Nabiqasim
166. -do- Ormax sachet Form-5 1. Firm has not applied Approved. Firm will
for the WHO reduced provide approval of
Sachet 18-2-2014 osmolarity formulation. technical staff and
129
Each sachet contains:- of technical staff from approved issuance of
Sodium Chloride Ph. Rs.20,000/- licensing section. letter.
Eur.. 3.5g 3. Evidence of approval
Sodium Citrate Ph.Eur Rs.100.00/10s of Q.C staff by
.. 2.9g
sachet Licensing.
Potassium Chloride
Ph.Eur.. 1.5g 4. Address of
Glucose anhydrous manufacturer has been
Ph.Eur .... 20.0g mentioned as 11 km,
Electrolyte in the approval letter
whereas, 13km,
distance is 13km,
Multan.
PEDITRAL
Searle
WHO Reduced
Osmolarity:
Sodium Chloride
.. 2.6g
Tri-sodium citrate
dihydrate .. 2.9g
Potassium Chloride
.. 1.5g
Glucose anhydrous
.... 13.5g
167. -do- Montilak 4mg sachet Form-5 1. The reference brands Deferred for
are available as granules clarification of
Sachet 18-2-2014 whereas, powder dosage manufacturing process
619 R&I form has been proposed for granules.
Montilukast sodium
in the master
... Rs.20,000/- formulation.
4mg 2. Evidence of approval
Rs.225.00/14s of technical staff from
Leukotriene receptor sachet licensing section.
antagonist 3. Evidence of approval
of Q.C staff by
Licensing.
4. Evidence of
availability of gradient
130
HPLC required.
5. Address of
mentioned as 11 km,
whereas, 13km,
distance is 13km,
Multan.
AEROKAST
4mg Sachet
Barrett Hodgson
SINGULAIR
4mg granules
Merck & Co. Inc.
US FDA
168. -do- Biocalcin-D sachet Form-5 1. Evidence of me too Deferred for
status is arbitrary as the confirmation of me
Sachet 18-2-2014 reference provided is too status.
618 R&I available in tablet
dosage form. Complete
Calcium Lactate
Gluconate Rs.20,000/- details like name of
.. manufacturer, brand
1000mg Rs.122.00/10s name, strength, dosage
Calcium carbonate sachet form and registration
... number required. In case
327mg of non me too
Vitamin C .. formulation application
500mg on Form 5D along with
Vitamin D3 ... requisite fee required.
4mg
Vitamin B6 .
10mg of technical staff from
licensing section.
Calcium supplement 3. Evidence of approval
of Q.C staff by
Licensing.
4. Address of
mentioned as 11 km,
131
whereas, 13km,
distance is 13km,
Multan.
169. -do- Biocalcin sachet Form-5 1. Evidence of approval Approved. Firm will
of technical staff from provide approval of
Sachet 18-2-2014 licensing section. technical staff and
of Q.C staff by approved issuance of
Calcium lactate
Gluconate Rs.20,000/- Licensing. letter
. 3. Address of
1000mg Rs.96.00/10s manufacturer has been
Calcium carbonate sachet mentioned as 11 km,
.. Lutfabad Road Multan
327mg in the approval letter
Vitamin C . from Licensing division
500mg whereas, 13km,
Calcium supplement
distance is 13km,
Multan.
VITASCOT
Scottman
Pharmaceuticals
170. -do- Hamazol Plus sachet Form-5 1. Evidence of approval Deferred for review of
of technical staff from formulation by review
Sachet 18-2-2014 licensing section. committee.
616 R&I 2. Evidence of approval
of Q.C staff by
Omeprazole .
20mg Rs.20,000/- Licensing.
Sodium bicarbonate 3. Address of
. Rs.149.00/10s manufacturer has been
1100mg sachet mentioned as 11 km,
132
Anti-ulcerant in the approval letter
whereas, 13km,
distance is 13km,
Multan.
RISEK INSTA
20 / 1100mg
Getz Pharma
171. -do- Coral-C sachet Form-5 1. Firm had applied for Deferred for vitamin
formulation which was policy.
Sachet 18-2-2014 different from the me
615 R&I too formulation. Now
the formulation has been
Calcium
glycerophosphate Rs.20,000/- revised to the me too
. formulation having
373.3mg Rs.94.00/10s 50mg Nicotinamide
Calcium carbonate sachet instead of 30mg.
. 2. Evidence of approval
156.7mg of technical staff from
Vitamin C ... licensing section.
100mg 3. Evidence of approval
Calcium pantothenate of Q.C staff by
..
Licensing.
15mg
Vitamin B6 ... 4. Address of
10mg manufacturer has been
Vitamin B1 ... mentioned as 11 km,
15mg Lutfabad Road Multan
Vitamin B2 ... in the approval letter
15mg from Licensing division
Nicotinamide .... whereas, 13km,
30mg Lutfabad Road, Multan
Calcium supplement
distance is 13km,
Multan.
133
Multical Plus
Nabiqasim
172. M/s. Shrooq Glovat Lotion Form-5 1. Firm had initially Deferred for
Pharma Lahore applied for 0.05% lotion. confirmation of
Lotion 20-2-2014 However, now the firm manufacturing facility
Additional 264 R&I has revised the strength for lotion.
Section: Each contains:- to 0.1% (w/v) and
Cream/Ointment Betamethasone (as Rs.20,000/- provided references for
Steroid Section valerate).0.05% the 0.1% strength.
vide letter No. F.6- w/w As per SRO / 20ml
2/2013-Lic (M- & 30ml
233) Corticosteroid International reference
of Betnovate 0.1%
Lotion has been
mentioned
Betnovate 0.1% Lotion

Gsk
Panel inspection report

dated 28/03/2014
wherein, it is mentioned
that firm has rectified
almost all observations
mentioned in previous
GMP inspection.
173. -do- Glovat-N Lotion Form-5 1. International Deferred for
availability has not been confirmation of
Lotion 20-2-2014 provided. Evidence of manufacturing facility
264 R&I approval of same for lotion.
Each ml contains:- formulation in same
Betamethasone as Rs.20,000/- strength and dosage
valerate.0.1% (w/v) form as approved by a
Neomycin stringent regulatory
sulphate..0.5% As per SRO / 20ml agency (e.g., US FDA,
(w/v) TGA, EMA, Health
Canada or MHLW)
Corticosteroid- required.
antibiotic
BETNOVATE - N
0.1 / 0.5% W/V Lotion
Gsk
174. -do- Glovat Cream Form-5 BETNOVATE Approved.

1mg / g Cream
Cream 20-2-2014 TGA
262 R&I
Each gram contains:-
Betamethasone Rs.20,000/- BETNOVATE
valerate eq. to 0.1% W/W Cream
134
Betamethasone . GSK
0.1% w/w As per SRO /
10gm, 15gm
corticosteroid
175. -do- Globeta Lotion Form-5 1. Firm has applied for Deferred for
registration on w/w confirmation of
Lotion 20-2-2014 basis. However, formulation &
261 R&I internationally and manufacturing facility
Each ml lotion
locally the product is for lotion.
contains:-
Clobetasol Rs.20,000/- available on w/v basis.
Propionate.0.05% CLOBEX Lotion
w/w 0.05%
As per SRO / 20ml US FDA
Corticosteroid
CLOBEDERM
0.05% w/v Lotion and
w/w Cream
Atco
176. -do- Glovat-N cream Form-5 Betamethasone (0.1% Approved.

w/w) and Neomycin
Cream 20-2-2014 (0.5% w/w) Cream
260 R&I BNF
Each gram contains:-
Betamethasone as Rs.20,000/-
valerate..0.1% BETNOVATE N
(w/w) 0.1 / 0.5% w/w
Neomycin As per SRO / 15gm Gsk
sulphate0.5%
(w/w)
Corticosteroid-
antibiotic
177. -do- Fusiglo-H Cream Form-5 FUCIDIN H Cream Approved.

Health Canada
Cream 20-2-2014
259 R&I FUSAC H
Each gram contains:- Sante
Fusidic Rs.20,000/-
acid20mg
Hydrocortisone
acetate.10mg As per SRO / 15gm
Corticosteroid-
antibacterial
178. -do- Glovat-G Cream Form-5 VALISONE G Approved.
Betamethasone (as
Cream 20-2-2014 valerate) 1mg and
258 R&I Gentamicin (as
135
Each gram contains:- Sulphate) 1mg
Betamethasone as Rs.20,000/- Schering
valerate.0.1%w/w Health Canada
Gentamicin as
sulphate..0.1% w/w As per SRO / 10gm GENTICYN B cream
& 15gm Reckitt Benckiser
Corticosteroid
179. -do- Procort-G Cream Form-5 1. Evidence of Deferred for

international availability confirmation of
Cream 20-2-2014 (e.g., US FDA, TGA, international
257 R&I EMA, Health Canada or availability.
Each gram contains:- MHLW) is ambiguous
Betamethasone as Rs.20,000/- and incomplete.
dipropionate.0.05% Verification required.
(w/w)
Gentamicin as As per SRO / 10gm,
sulphate.0.1% 15gm
(w/w) DIPGEN
Mass Pharma
Corticosteroid-
antibiotic
180. -do- Globeta Cream Form-5 TERMOVATE Approved.
0.05% w/w Cream
Cream 20-2-2014 US FDA
256 R&I
each gram contains:-
Clobetasol Rs.20,000/- DERMOVATE 0.05%
propionate.0.05%w w/w Cream
/w Gsk
As per SRO / 15gm
Corticosteroid
136
Case No.05. Remaining Registration Applications of New / Additional sections.
The Registration Board has been granting 10 products per section to newly approved
sections. Following are the remaining products of the applicants as per above policy.
Evaluator II
S/N Name and Brand Name Type of Remarks on the formulation Decision
address of Form (if any) including
manufacturer / (Proprietary International status in
Applicant name + Initial stringent drug regulatory
Dosage Form date, diary agencies / authorities
+ Strength)
Fee Me-too status
Composition including
differentia GMP status as depicted in
Pharmacologi l fee latest inspection report (with
cal Group date) by the Evaluator
Demanded
Finished Price /
product Pack size
Specification
181. M/s. Simz Lansim 30mg Form-5 BNF 66 Approved.

Pharmaceuticals Capsule
(Pvt) Ltd, 574-575 Each capsule Rs.20,000/- DOUDCER-NIL (GLOBAL
Sundar Industrial contains:- 10-2-2014 PHARMACEUTICALS)
Lansoprazole
Estate, Raiwind
enteric coated
Road Lahore. Rs.378/27 GMP compliant (22-11-2013)
pellets
equivalent to s
Sections approved Lansoprazole.
1. Tablet (Gen/ 30mg
Gen antibiotic) (Antiulcer)
2. Capsule (Gen/ ( USP Spec.s)
Gen antibiotic) Source of pellets:
3. Dry Powder M/s Vision
Suspension (Gen/ Pharmaceuticals,
Plot No. 224, I-
Gen antibiotic) 10/3, Islamabad
4. Liquid Syrup
Vide letter No. F.
1-50/2005-Lic
dated 28-09-2012
137
182. -do- Pantone 40mg Form-5 Not confirmed Deferred for confirmation of
Capsule international availability.
Each capsule Rs.20,000/- PANTEV (EVEREST
contains:-
10-2-2014 PHARMACEUTICALS)
Pantoprazole
sodium enteric
coated pellets Rs.308/2x7 GMP compliant (22-11-2013)
equivalent to s
Pantoprazole4 1. International availability
0mg especially in FDA, EMA,
(Antiulcer) Health Canada, TGA &
(Manufacturer MHLW is required. Firm has
s Spec.s) given reference of Protonix
Source of from FDA that is available in
pellets: M/s
delayed release Tablet dosage
Vision
form not in Capsule form.
Pharmaceutical
s, Plot No. 224,
I-10/3,
Islamabad
183. -do- Mecogym 0.5mg Form-5 Methycobal (Eisai Bunkyo) Deferred for confirmation of
Capsule Japan international availability.
Each capsule Rs.20,000/-
contains:- 10-2-2014
Mecobalamin
(J.P)..500mcg MECOL (EPLA
Rs.252.40/1 LABORATORIES (PVT)
(Co-enzyme)
(Manufacturers 0x3s LTD.)
Spec.s)
GMP compliant (22-11-2013)
184. -do- SimKast 5mg Form-5 Not confirmed Deferred for review of
Dry Powder Dry formulation by review
Suspension (Gen/ Suspension Rs.20,000/- Synkast (Synchro) committee.
Gen antibiotic) Each 5ml 10-2-2014
contains:- GMP compliant (22-11-2013)
Montelukat Rs.200.00/
Sodium 60ml 1. Formulation is under
equivalent to
review
Montelukast
(USP)5mg
(Anti-
asthmatic)
(Manufacturer
s Spec.s)
138
185. -do- Aflocan 50mg Form-5 BNF. Diflucan Approved.
Dry Suspension (Pfizer)
Each 5ml Rs.20,000/-
contains:- 10-2-2014 Flu-z (Z-Jans)
Fluconazole
(USP)50mg Rs.230.00/ GMP compliant (22-11-2013)
(Antifungal) 35ml
(Manufacturer
s Spec.s)
186. -do- Zinmax 20mg Form-5 Not confirmed Approved.

Liquid Syrup Syrup
Each 5ml Rs.20,000/- Zynq (Nabiqasim) (Firm has got five products in
contains:- 10-2-2014 Liquid syrup which have been
Zinc sulphate GMP compliant (22-11-2013) already registered. Now, six
monohydrate Rs.75.00/6 products have been included in
equivalent to 0ml 1. International availability in current agenda as one product
elemental Zinc Carafate suspension was
FDA, EMA, Health
(USP)..20mg initially applied as dry powder
Canada, TGA & MHLW
(Anti-diarrheal) suspension and then later on
(USP Spec.s) for same generic, dosage converted to liquid suspension
form & strength with after evaluation. The firm will
reference is required. Firm be granted 10 products per
has given the reference of section as per policy.)
Immuzinc of Phillipines.
187. -do- Dopedom 5mg Form-5 BNF Domperidone (Non- Deferred for review of
Liquid proprietary) formulation by review
Suspension Rs.20,000/- committee.
Each 5ml 10-2-2014 Motilium (Jansen)
contains:-
Domperidone Rs.85.00/1 GMP compliant (22-11-2013)
(B.P)..5mg 20ml
(Anti-emetic,
anti-
dopaminergic)
(Manufacturer
s Spec.s)
188. -do- Ibusim DS Form-5 Not confirmed Deferred for confirmation of

200mg international availability.
Liquid Rs.20,000/- Brufen DS (Abbot)
Suspension 10-2-2014
Each 5ml GMP compliant (22-11-2013)
contains:- Rs.60.00/9
Ibuprofen 0ml 1. International availability
(B.P)..200m especially in FDA, EMA,
g
(Antirheumatic, Health Canada, TGA &
anti- MHLW for same generic,
inflammatory) dosage form & strength
139
(B.P Spec.s) with reference is required.
Firm has provided Dolan
Fp Forte from Phillipine.
189. -do- Ferogym Form-5 Not confirmed Approved.
Syrup
Each 15ml Rs.20,000/- Ferital (Don Valley)
contains:- 10-2-2014
Iron protein GMP compliant (22-11-2013)
succinylate Rs.68/120
800mg ml 1. International availability
equivalent to especially in FDA, EMA,
elemental
iron40mg Health Canada, TGA &
(Haematonic) MHLW for same generic,
(Manufacturer dosage form & strength
s Spec.s) with reference is required.
Firm has submitted that
Ferretts IPS is available in
USA. Ferretts IPS is not
mentioned in US-FDA.
190. -do- Famosim 10mg Form-5 PEPCID (FDA) is dry powder Defererd for review of
Liquid for suspension. USP also formulation by review
Suspension Rs.20,000/- mentions it Powder for Oral committee.
Each 5ml 10-2-2014 suspension
contains:-
Famotidine Rs. Polypep (Wilson)
(U.S.P)10 68.00/90ml
mg GMP compliant (22-11-2013)
(H2 receptor
antagonist) 2. FDA approved Pepcid is
(U.S.P Spec.s)
dry powder for
suspension. Firm has
applied liquid suspension.
Firm has replied that
Polypep (Wilson) is liquid
suspension.
3. The strenght of Pepcid
(FDA) is 40mg/5ml.
140
191. -do- Carafate 1gm Form-5 BNF : Antepsin Approved.
Liquid (Chugai)
Suspension Rs.20,000/-
Each 5ml 10-2-2014 ULSANIC (HIGHNOON
contains:- LABORATORIES LTD.)
Sucralfate Rs.121.70/
(USP)1gm 60ml GMP compliant (22-11-2013)
(Anti-ulcer)
(Manufacturer 1. The Firm had replied the
s Spec.s) product as dry suspension
dosage form. The
formulation is
internationally in liquid
suspension dosage form.
In reply to evaluation
letter the firm requested to
convert the dosage form to
liquid suspension and
provided new Form 5 and
documents.
2. The Firm has already 5
products registered in
Liquid syrup section and
applied 6 products
including this product.
Evaluator III
address of (Proprietary name formulation (if any)
manufacturer / + Dosage Form + Initial date, including
Applicant Strength) diary International status
in stringent drug
Composition Fee including regulatory agencies
differential fee / authorities
Pharmacological
Group Demanded Price Me-too status
/ Pack size
Finished product GMP status as
Specification depicted in latest
inspection report
(with date) by the
Evaluator
141
192. M/s EG Amika Injection Form 5 Amikacin 250mg/ml Deferred for provion
Pharmaceuticals, 500mg BNF 61 of evidence of TOC
13-A Industrial Dy No 6805 analyzer & latest
Triangle Kahuta Each 2ml vial dated 31/10/13 Grasil of Sami GMP inspection
Road Islamabad. contains Amikacin Pharmaceuticals report.
as 20,000/- Karachi
Sulphate500mg
As per SRO Inspection of the firm
Aminogylycoside was conducted on
26/03/14 by the DDG
USP (E&M) and area FID
and certain
discrepancies are
observed of which
the management has
agreed to rectify
within one month.
Evaluator IV
address of (Proprietary name + formulation (if
manufacturer/ Dosage Form + Initial date, diary any) including
Applicant Strength) International
Fee including status in stringent
Composition differential fee drug regulatory
agencies /
Pharmacological Demanded Price / authorities
Group Pack size
Me-too status
Finished product
Specification GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
193. M/s Hiranis Agolix Sachet Form-5 D International: Not Defered for provision of
Pharmaceutical Sachet 04-03-2014 found in reference safety and efficacy data.
Pvt. Ltd. Plot.No. Each sachet contains Dy.No. 184 drug agencies, Moreover firm will
E-145-149, North Doxofylline 200 mg 04-03-2014 however, Ansimar provide data as decided
western Industrial (Xanthine Derivative) Rs.50,000/- Sachet 200 mg for new dosage form in
Zone, Port Qasim, Finished product 10s present in Italy. 240th meeting
Karachi specifications are Rs. 160/ pack Local: New drug
Sachet Section Manufacturer. Firm was inspected
(General) on 17th& 23rd
September 2013,
for grant of DML
by way of form
formulation.
142
Evaluator V
Sr. Name and Brand Name Type of Form Remarks on the Decision
No. address of (Proprietary name formulation (if any)
Manufacturer / + Dosage form + Initial date, diary including
Applicant Strength) International status
Fee including in stringent
Composition differential fee regulatory agencies /
authorities
Pharmacological Demanded Price /
Group Pack size Me-too status

specification depicted in
inspection report
(dated)
194 M/s Martin Dow BOXIN DRY Form 5 125mg/5ml dry Deferred for
Ltd. Plot.No.37, SUSPENSION powder suspension not confirmation of
Sector 19, Korangi 125mg/5ml 21/04/2014 462 R&I approved by reference international
Industrial Area drug agencies availability in
Karachi. Each 5ml suspension Rs. 20,000/- stringent DRAs.
contains:
Ciprofloxacin as Hcl Rs. 100 per 60ml Inspection report dated
Rs. 148.5 per 90ml 08/01/2014.
125mg GMP compliance level
rated as good.
Ciprofloxacin taste
masked granules
35%
Source: Vision
Pharmaceuticals
Islamabad
Manufacturers
specifications
195 -do- BOXIN DRY Form 5 250mg/5ml dry Approved as per
SUSPENSION powder suspension not originator formulation
250mg/5ml 21/04/2014 461 R&I approved by reference
drug agencies.
Each 5ml suspension Rs. 20,000/- However, 250mg /5ml
contains: microcapsules as
Ciprofloxacin as Hcl Rs. 176 per 60ml ciprofloxacin base is
Rs. 264 per 90ml available.
250mg
Ciprofloxacin taste
masked granules Inspection report dated
143
35% 08/01/2014.
GMP compliance level
Source: Vision rated as good.
Pharmaceuticals
Islamabad
Manufacturers
specifications
Case No.06. Registration Applications for Contract Manufacturing.
Evaluator II
address of (Proprietary Initial date, formulation (if any)
manufacturer / name + Dosage diary including
Applicant Form + Strength) Fee including International status
Composition differential fee in stringent drug
Pharmacological Demanded regulatory agencies
Group Price / Pack / authorities
Finished product size Me-too status
depicted in latest
inspection report
(with date) by the
Evaluator
196 M/s Welwink Acticef 500mg Form 5 FDA. (Rocephin Deferred for GMP
Pharmaceuticals. Powder for (Roche) inspection of contract
G.T Road, reconstitution 18-07-2012 manufacturer by
Industrial Estate, Injection IM Dy No 7333 SPORCEF(LOWITT panel comprising of
Each Vial contains:-
Gujranwala 21-05-2013 PHARMACEUTICA Dr. Muzammal H.
Ceftriaxone Sodium
Cantt. eq. to
Rs. 150,000/- LS (PVT) LTD) Najmi, Director QA
Gujranwala Ceftriaxone & LT and area FID.
.500mg As Per SRO Advised for further Contract giver will
Contract (Cephalosporin 1s improvement in be inspected by area
Manufacturing Antibiotic) vial different sections. (22- FID as last inspection
by (USP Spec.s) 03-2014) report is more than
01 year old
M/s Weather
Folds
Pharmaceuticals.
Plot 69/2, Phase-
2, Industrial
Estate, Hattar
197 -do- Acticef 250mg Form 5 BNF. (Rocephin Deferred for GMP
Powder for (Roche) inspection of contract
reconstitution 18-07-2012 manufacturer by
144
Injection IM Dy No 7336 SPORCEF(LOWITT panel comprising of
Each Vial contains:- 21-05-2013 PHARMACEUTICA Dr. Muzammal H.
Ceftriaxone Sodium Rs. 150,000/- LS (PVT) LTD) Najmi, Director QA
eq. to & LT and area FID.
Ceftriaxone
As Per SRO/1s Advised for further Contract giver will
.250mg
vial improvement in be inspected by area
(Cephalosporin
Antibiotic) different sections. (22- FID as last inspection
03-2014) report is more than
01 year old
198 -do- Acticef 250mg Form 5 BNF. (Rocephin Deferred for GMP
Powder for (Roche) inspection of contract
reconstitution 18-07-2012 manufacturer by
Injection IV Dy No 7338 SPORCEF(LOWITT panel comprising of
Each Vial contains:-
21-05-2013 PHARMACEUTICA Dr. Muzammal H.
Ceftriaxone Sodium
eq. to Rs. 150,000/- LS (PVT) LTD) Najmi, Director QA
Ceftriaxone & LT and area FID.
.250mg As Per SRO Advised for further Contract giver will
(Cephalosporin 1s improvement in be inspected by area
Antibiotic) vial different sections. (22- FID as last inspection
03-2014) report is more than
01 year old
Evaluator III
address of (Proprietary formulation (if any)
manufacturer / name + Dosage Initial date, including
Applicant Form + diary International status in
Strength) stringent drug
Composition differential authorities
fee
Pharmacological Me-too status
Group Demanded
Price / Pack GMP status as
Finished size depicted in latest
product inspection report
Specification (with date) by the
Evaluator
199 Weather Fold Acticef Injection Form 5 Rociphen of Gentech Deferred for GMP
Pharmaceuticals 500mg (I.V) USA inspection of contract
Hattar for M/s 18-07-12 Dy manufacturer by panel
Welwink Each vial No 7341 Rociphen of Roche comprising of Dr.
Pharmaceuticals, contains Rs 8000/- Karachi Muzammal H. Najmi,
Gujranwala Ceftriaxone 21-05-13 Dy Director QA
145
sodium eq to No 3283 Inspection of the M/s & LT and area FID.
Ceftriaxone 1,42,000/- Weather Folds Contract giver will be
500mg Pharmaceuticals, inspected by area FID as
As per SRO/ Hattar was conducted last inspection report is
Cephalosporin Pack of 1s by the area FID on more than 01 year old
Antibiotic 22/03/14 and advised
firm for further
USP improvements in
different sections.
200 -do- Acticef Injection Form 5 Rociphen of Gentech Deferred for GMP
1gm(I.M) USA inspection of contract
18-07-12 Dy manufacturer by panel
Each vial No 7334 Rociphen of Roche comprising of Dr.
contains Rs 8000/- Karachi Muzammal H. Najmi,
Ceftriaxone 21-05-13 Dy Director QA
sodium eq to No 3283 & LT and area FID.
ceftriaxone 1,42,000/- Contract giver will be
.1g inspected by area FID as
As per SRO/ last inspection report is
Cephlosporin Pack of 1s more than 01 year old
Antibiotic
USP
201 -do- Acticef Injection Form 5 Rociphen of Gentech Deferred for GMP
1gm( I.V) USA inspection of contract
18-07-12 Dy manufacturer by panel
Each vial No 7339 Rociphen of Roche comprising of Dr.
contains Rs 8000/- Karachi Muzammal H. Najmi,
Ceftriaxone 21-05-13 Dy Director QA
sodium eq to No 3283 & LT and area FID.
Ceftriaxone Rs 1,42,000/- Contract giver will be
.1gm inspected by area FID as
As per SRO/ last inspection report is
Cephalosporin Pack of 1s more than 01 year old
Antibiotic
USP
146
Evaluator IV
S/N Name and Brand Name Type of Form Remarks on the formulation Decision
address of (Proprietary (if any) including
manufacturer/ name + Dosage Initial date, International status in
Applicant Form + Strength) diary stringent drug regulatory
agencies / authorities
Composition Fee including
differential Me-too status
Pharmacological fee
Group GMP status as depicted in
Demanded latest inspection report (with
Finished product Price / Pack date) by the Evaluator
Specification size
202 M/s Weather Maxoxim Form 5 International: Suprax for Deferred for GMP
Folds 200mg/5ml 18-07-2012 suspension 200mg/5ml (FDA) inspection of contract
Pharmaceuticals. Dry Suspension Dy No 7330 Local: Biozil Dry Suspension manufacturer by panel
Plot 69/2, Phase-2, Each 5 ml Rs. 150,000/- 200 mg/5 ml by M/s BioLabs comprising of Dr.
Industrial Estate, contains As per SRO According to report of Muzammal H. Najmi,
Hattar Cefixime inspection dated 22-10-2014 of Director QA
For USP200 M/s Weather f old, firm is & LT and area FID.
mg advised to rectify shortcomings Contract giver will be
M/s Welwink (Cephalosporin) in various sections. inspected by area FID as
Pharmaceuticals. According to report of last inspection report is
G.T Road, Finished product inspection dated 13-06-2013 of more than 01 year old
Industrial Estate, specifications are M/s Welwink, inspection book
Gujranwala Cantt. USP was not available at time of
Gujranwala inspection and firm was once
again directed to submit their
validation data of areas and
processes before starting of
their production.
203 M/s Weather Maxoxim 1.Form 5 International: Suprax for Deferred for GMP
Folds 100mg/5ml 2.18-07-2012 suspension 100mg/5ml (FDA) inspection of contract
Pharmaceuticals. Dry Suspension Dy No 7335 Local: Biozil Dry Suspension manufacturer by panel
Plot 69/2, Phase-2, Each 5 ml 3. 21-05-2013 100 mg/5 ml by M/s Bio Labs comprising of Dr.
Industrial Estate, contains Rs. 150,000/- According to report of Muzammal H. Najmi,
Hattar Cefixime inspection dated 22-10-2014 of Director QA
For USP100 M/s Weather f old, firm is & LT and area FID.
mg advised to rectify shortcomings Contract giver will be
M/s Welwink (Cephalosporin) in various sections. inspected by area FID as
Pharmaceuticals. According to report of last inspection report is
G.T Road, Finished product inspection dated 13-06-2013 of more than 01 year old
Industrial Estate, specifications are M/s Welwink, inspection book
Gujranwala Cantt. USP was not available at time of
Gujranwala inspection and firm was once 147
again directed to submit their
their production.
204 M/s Weather Maxoxim 400 mg 1.Form 5 International: Suprax Capsule Deferred for GMP
Folds Capsule 2.18-07-2012 400mg inspection of contract
Pharmaceuticals. Each capsule Dy No 7335 Local: Biozil Capsule 400 mg manufacturer by panel
Plot 69/2, Phase-2, contains Cefixime 3. 21-05-2013 by M/s Bio Labs comprising of Dr.
Industrial Estate, BP 400 mg Rs. 150,000/- According to report of Muzammal H. Najmi,
Hattar (Cephalosporin) inspection dated 22-10-2014 of Director QA
For M/s Weather f old, firm is & LT and area FID.
Finished product advised to rectify shortcomings Contract giver will be
M/s specifications are in various sections. inspected by area FID as
Welwink Manufacturing. According to report of last inspection report is
Pharmaceuticals. inspection dated 13-06-2013 of more than 01 year old
G.T Road, M/s Welwink, inspection book
Industrial Estate, was not available at time of
Gujranwala Cantt. inspection and firm was once
Gujranwala again directed to submit their
their production.
Case No.07. Routine Registration Applications before August, 2010.
Evaluator III
Name and Brand Name Type of Remarks on the formulation (if any) Decision
address of (Proprietary Form including International status in
manufacturer / name + Dosage stringent drug regulatory agencies /
Applicant Form + Initial date, authorities
Strength) diary
Me-too status
Composition Fee
including GMP status as depicted in latest
Pharmacological differential inspection report (with date) by the
Group fee Evaluator
Finished Demanded
product Price / Pack
Specification size
205 M/s Bosch Troz Tablet Form 5 Flagyl of Winthrop. Approved.
Pharmaceuticals 200mg
(Pvt) Ltd, 221, Dy No 2431 Flagyl of Sanofi Karachi.
Bosch House, Each film coated dated
Sector 23, tablet contains 31/10/06 Inspection of the firm was conducted on
Korangi Metronidazole 11-06-14 by panel of inspectors and
industrial area, 200mg 8000+12000 recommended the grant of Oral Dry
Karachi. Powder Suspension (General) section
Oral synthetic Pack of and certain modfications in other
antiprotozoal and 20x10s/ Rs sections.
148
antibacterial 170/-
agent.
USP
206 -do- Troz Tablet Form 5 Flagyl of Winthrop. Approved.
400mg
Dy No 2429 Flagyl of Sanofi Karachi.
Each film coated dated
tablet contains 31/10/06
Metronidazole
400mg 8000+12000
Oral synthetic Pack of

antiprotozoal and 20x10s/ Rs
antibacterial 250/-
agent.
USP
207 M/s Zephyr Ozop Capsule Form 5 Losec of AstraZeneca Approved.
Pharmatec (Pvt) 40mg
Limited, A-39, Dy No 1033 Risek of Getz Karachi
S.I.T.E. II Each capsule dated
Super highway contains enteric 28/05/10 Inspection of the firm was carried out
Karachi. coated pellets of on 23-03-14 by area FID in which he
Omeprazole 15000+85000 has not reported any GMP violation.
22.5% equivalent
to Omeprazole Pack of 14s/ An undertaking as per descion of 241st
USP..40mg Rs 275/- meeting of Registration Board of DRAP
to submit the following before
Anti-Ulcer marketing of drug product.
USP i. Stability studies

Source: M/s iii. Pharmaceutical
Meenaxy Pharma development
(Pvt) Limited, Sy iv. Validation of analytical
No.30, Suraram method
Quthbullapur, v. Label claim and
R.R. District, prescribing information as
AndraPardesh, per approved by drug
India regulatory agencies or
MHLW.
149
208 -do- Naudon Form 5 Domperodone Suspension BNF 61 Deferred for
Suspension review of
Dy No 1031 Domel of Barrett & Hodgson Karachi formulation by
Each 5ml of dated review
suspension 28/06/10 Inspection of the firm was carried out committee.
contains on 23-03-14 by area FID in which he
Domperidone 8000+12000 has not reported any GMP violation.
B.P..5mg
Pack of 1s/ An undertaking as per descion of 241st
Anti emetic, Anti Rs 90/- meeting of Registration Board of DRAP
nauseant to submit the following before
marketing of drug product.
Manufacturer
i. Stability studies
iii. Pharmaceutical
development
iv. Validation of analytical
method
v. Label claim and
MHLW
Case No.08. Deferred Registration Applications which have been replied by the applicant.
Evaluator II
S/N Name and Brand Name Type of Form Decision of Remarks on the Decision
address of Previous formulation (if any)
manufacturer / (Proprietary Initial date, Meeting including
Applicant name + Dosage diary International status
Form + in stringent drug
Strength) Fee including
differential fee regulatory agencies /
authorities
Composition
Demanded
Me-too status
Pharmacologic Price / Pack
al Group size
GMP status as
depicted in latest
Finished
product inspection report
Specification (with date) by the
Evaluator
150
209 M/s Novartis Nocid Form 5 Deferred for PEPCID (FDA) is Deferred for reiew of
Pharma Oral Suspension latest GMP dry powder for formulation by review
(Pakistan) Each 5ml 28-01-13 (Rs. inspection suspension. USP also committee.
report as last mentions it Powder
Limited, Petaro contains:- 20,000),
inspection for Oral suspension
Road, Jamshoro, Famotidine 26-03-13 (Rs. report is of and in 40mg/5ml
Sindh. 10mg 40000/-) dated strength.
(Antipeptic 08.02.2012.
Ulcerant) Rs.68/60ml (M-242 of ACICON
(Manufacturers Rs. DRB) (BARRETT
Spec.s) 136/120ml HODGSON)
Acceptable level of
GMP compliance
(15,17-10-2013)
1. The Firm has

submitted copy
of inspection
report dated 17-
10-2013.
2. FDA approved
Pepcid is dry
powder for
suspension. Firm
has applied liquid
suspension. In
Pakistan both
liquid suspension
and dry powder
for suspension
are available.
3. The strenght of
Pepcid (FDA) is
40mg/5ml.
151
210 -do- Acemed Form 5 Deferred for Not confirmed Deferred for
Gel latest GMP confirmation of
Each 100gm gel 29-12-10, (N/A) inspection ALKERIS(SAMI) international
report as last availability in
contains:- (Rs. 8000/-),
inspection Acceptable level of Stringent Regulatory
Aceclofencac 16-07-13 (Rs. report is GMP compliance agencies.
(B.P) 1.5% 52000/-) 08.02.2012. (15,17-10-2013)
(Anti- (M-242 of
inflammatory,A Rs.300/50 gm DRB) 1. The Firm has
nti-pyretic & pack submitted copy
Analgesic) of inspection
(Manufacturers report dated 17-
Spec.s) 10-2013.
2. International
availability in
FDA, EMA,
Health Canada,
TGA & MHLW
for same generic,
Dosage form &
strength not
confirmed. Firm
has provided AC-
Rub from India.
211 M/s. Metro Tizaid Tablets Form-5 Deferred due to BNF: Zanaflex Approved.
Pharmaceuticals Each tablet non- (Cephalon)
Plot # 14, Street contains:- 2/7/2012, (5999) compliance of
No SS-2, Tizanidine (as Rs. 8,000/- GMP as MOVAX(SAMI)
National HCl) 12-3-2013 Rs. reported by
Industrial Zone, (U.S.P).. 12,000/- area FID. Complying GMP,
Rawat, 4mg 2/10/2013 Rs. (M-242 of GMP Certificated
Rawalpindi (Skeletal Muscle 40,000/- DRB) recommended. (25-
Relaxant) 03-2014)
(USP Spec.s) As Per SRO per
10s 1. The Firm has
submitted copy of
GMP inspection
report dated 25-03-
2014 and GMP
certificate dated
01-04-2014.
152
212 M/s Wisdom Lordex Form5 Deferred for Not confirmed Deferred for
Pharmaceuticals Capsules confirmation of confirmation of
Industry, Each capsule 10-9-2013 international Breen(Goodman international
78-A, Industrial contains:- Dy.No.287 availability. International) availability in
Estate Cefpodoxime (Rs.20000/-) (M-243 of stringent regulatory
Hayatabad, Proxetil DRB) Grant of DML agencies.
Peshawar. Cefpodoxime As per SRO /10s recommended (25-
(U.S.P)100mg 04-13)
(Cephalosporin)
(Manufacturers 1. The Firm has
) submitted that
Cefpodoxime
100mg capsule is
registered with a
number of Firms in
Pakistan and in
Bagladesh, India
and Chian, while
100mg Tablet is
available in U.S.
FDA.
2. The Firm has
requested for grant
of Registration.
153
Evaluator III
a) Deferred cases of 241st Meeting of Registration Board
S/N Name and Brand Name Type of Form Previous Remarks on the Decision
address of (Proprietary name Decision in formulation (if
manufacturer / + Dosage Form + Initial date, M-241 any) including
Applicant Strength) diary International
status in
Composition Fee including stringent drug
differential fee regulatory
Pharmacological agencies /
Group Demanded authorities
Price / Pack size
Finished product Me-too status
Specification
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
213 M/s Medizan Reflux Capsules Form5 Deferred for The firm has Approved.
Laboratories Pvt 40mg submission of submitted
Limited, Plot No 18-04-2013 following requisite
313, Inustrial Each capsule Dy.No.1366 information by documentation as
Triangle Kahuta, contains Omeprazole the firm: per decision of
Islamabad. enteric coated pellets 60,000/- 1. GMP of M-241.
8.5% equivalent to Source
Omeprazole..40mg As per SRO/ 2. COA Losec (BNF 61)
2x7s 3. Stability
PPI 4. Fee (in case Risek of Getz
of import) Karachi
Manufacturer
Source: Vision
Pharmaceuticals
Islamabad.
154
b) Deferred cases of 242nd Meeting of Registration Board
S/N Name and Brand Name Type of Form Previous Remarks on the Decision
address of (Proprietary name Decision in formulation (if
manufacturer / + Dosage Form + Initial date, M-242 any) including
Applicant Strength) diary International
status in stringent
Composition Fee including drug regulatory
differential fee agencies /
Pharmacological authorities
Group Demanded
Price / Pack size Me-too status
Finished product
depicted in latest
inspection report
(with date) by the
Evaluator
214 M/s Caraway AVIMER Tablets Form 5 Deferred for The formulation is Deferred for
Pharmaceuticals, 800mg confirmation approved in the confirmation of me
Plot No 12,Street 5802dated of me too 243rd meeting of too status.
No 3,National Each film coated 10/09/13 status Registration Board
Industrial Zone, tablet contains regarding salt of M/s Sanofi
Rawat, Islamabad Sevelamer Rs.60,000 form of API. Aventis Karachi
Carbonate Rs.90,000/- with brand name
800mg (27/05/2014) of Renvela 800mg
tablet.
Phosphate binder As per SRO
Pack of 30s Renvela Tablet
Manufacturer 800mg of
Genzyme UK
215 M/s. Highnoon Hilin Plus Tablets Form-5D Deferred as Product is not Rejected since the
Laboratories, requisite found in stringent formulation is
Lahore documentation regulatory irrational and not
as per Form-5 authorities found in SRA.
Each tablet contains Dy No 393 dated
Pregabalin..50mg 25-10-13 is not Moreover firm has
complete not provided safety
Methylcobalamin Clinical data
and efficacy data
(Change in
500mcg brand name) (along with data of
23/7/2012 (Rs.
clinical trials
15,000/-).
Neuropathic pain 30/7/2013 (Rs. conducted and
reliever 1,35,000/- safety data of drug,
with reorted side
155
effect and adverse
drug reactions in
Manufacturer Rs. 425//- per indigenous
10s tablet
community is
required as per
Form-5D
Inspection of the
firm was
conducted on 09th
January 2014 by
panel of inspectors
and recommended
the grant of GMP
certificate for
export purpose.
156
c) Deferred cases of 243rd Meeting of Registration Board
S/N Name and Brand Name Type of Previous Remarks on the Decision
address of (Proprietary Form Decision formulation (if
manufacturer / name + Dosage in any) including
Applicant Form + Initial date, M-243 International
Strength) diary status in stringent
drug regulatory
Composition Fee agencies /
including authorities
Pharmacological differential
Group fee Me-too status
Finished product Demanded GMP status as

Specification Price / Pack depicted in latest
size inspection report
(with date) by the
Evaluator
216 M/s Filix Flucofix Capsule Form-5 Deferred Diflucan of Pfizer Approved.
Pharmaceuticals 150mg for Inc
Islamabad Dy No 3062 completion
Each capsule dated 17-05- of Form-5 Diflucan of Pfizer
contains 13 Karachi.
Fluconazole
(BP).150mg 20,000/- Inspection of the
firm was
Fungicide As per SRO conducted by the
area FID on 17-01-
Manufacturer
14 and GMP
compliance is
found satisfactory.
157
Evaluator IV
a) Deferred Cases of 242nd meeting of Registration Board
S/N Name and Brand Name Type of Form Decision in Remarks on the Decision
address of (Proprietary M- 242 formulation (if any)
manufacture name + Dosage Initial date, including
r/ Applicant Form + diary International status
Strength) in stringent drug
Pharmacological Demanded Me-too status

Group Price / Pack GMP status as
size depicted in latest
Finished inspection report
product (with date) by the
Specification Evaluator
M/s
217.
Novartis Zumatram P Form 5 Deferred for Firm has provided Approved.
217 Pharma Film Coated Fast Track latest GMP inspection report of
(Pakistan) Tablets 13-11-13 inspection inspection conducted
Limited, 15 Each f/c tablet Rs 60,000/- report as last on 15-10-2013 of its
West Wharf, contains 10s, 20s inspection plant with address as
Karachi. Tramadol HCl PVC/PVDC/Al report is of Sandoz Nagar,
Factory: Ph. Eur 37.5 mg uminium Rs dated Jamshoro, Sindh. .
Petaro + Paracetamol 200/- Rs. 400/- 08.02.2012 This report states that
Road, Ph. Eur firm is operating at an
Jamshoro. 325 mg acceptable level of
(Analgesic) compliance to GMP
Manufacturer guidelines.
Specifications
218. M/s Novartis Zumatram Form 5 Deferred for Firm has submitted Deferred for
Pharma Prolonged release 23-05-13 submission below mentioned confirmation of
(Pakistan) tablets 24-09-13 of application documents: international
Limited, 15 Each prolonged Rs 60,000/- on Form 5D Differential availability. Moreover
West Wharf, release tablet 10s, Rs 346/- along with Fee firm will provide data
Karachi. contains requisite fee Registration as decided for new
Factory: Tramadol HCL and latest application on dosage form in 240th
Petaro 150mg GMP report Form 5 D meeting
Road, ( Analgesic) Latest
Jamshoro. Manufacturer inspection
Specifications Report
Medical
justification
Firm has provided 158
inspection report of
inspection conducted
on 15-10-2013 of its
plant with address as
Sandoz Nagar,
Jamshoro, Sindh.. This
report states that firm
is operating at an
acceptable level of
compliance to GMP
guidelines.
219. M/s Novartis Zumatram Form 5 Deferred for Firm has provided Approved.
Pharma Prolonged release 23-05-13 latest GMP inspection report of
(Pakistan) tablets 24-09-13 inspection inspection conducted
Limited, 15 Each prolonged Rs 60,000/- report as last on 15-10-2013 of its
West Wharf, release tablet 10s, Rs inspection plant with address as
Karachi. contains 230.63/- report is of Sandoz Nagar,
Factory: Tramadol HCL dated Jamshoro, Sindh. .
Petaro 100mg 08.02.2012 This report states that
Road, ( Analgesic) firm is operating at an
Jamshoro. Manufacturer acceptable level of
Specifications compliance to GMP
guidelines.
220. M/s Novartis Zumatram Form 5 Deferred for Firm has submitted Deferred for expert
Pharma Prolonged release 23-05-13 submission below mentioned opinion of Prof. Rauf
(Pakistan) tablets 24-09-13 of application documents: Niazi, Prof.I.U.Beg
Limited, 15 Each prolonged Rs 60,000/- on Form 5D Differential and Prof.Zafar Iqbal.
West Wharf, release tablet 10s, 461.26/- along with Fee Moreover firm will
Karachi. contains requisite fee Registration provide data as
Factory: Tramadol HCL and latest application on decided for new
Petaro 200mg GMP report Form 5 D dosage form in 240th
Road, ( Analgesic) Latest meeting
Jamshoro. Manufacturer inspection
Specifications Report
Medical
justification
Firm has provided
inspection report of
inspection conducted
on 15-10-2013 of its
plant with address as
Sandoz Nagar,
Jamshoro, Sindh.. This
report states that firm
is operating at an
acceptable level of
compliance to GMP
guidelines.
221. M/s Hoover Calcibeta Form-5 Deferred for Firm has submitted Approved.
Pharmaceutic Ointment 20-10-2009/ confirmation following documents:
als (Pvt.) Ltd. Each gram fee Rs. 8,000/- of 1. Copy of letter dated
159
Plot.No.16, contains. is photocopy of manufacturin 09th December issued
Zain Park, Calcipotriol BP challan form. g facilities by L & A to firm for
Sagian by 0.005% Rs.60,000/- for issuance of DML by
pass road Betamethasone 15 gm semisolids way of formulation in
Lahore. BP 0.05% As per SRO (Steroids) sections as Tablet
(Vitamin-D and (General), Capsule
Analogue/ submission (general), Cream/
Corticosteroid.) of Ointment (General),
undertaking Cream/ Ointment
regarding (Steroid).
pharmaceutic 2. An undertaking
al regarding provision of
development pharmaceutical
studies, development studies,
process process validation
validation, data, validation of
validation of analytical testings,
analytical stability studies &
testings, label claims & PI as
stability per approval of SRAs.
studies &
label claims
& PI as per
approval of
SRAs.
222. M/s Opal Oplamanic-Cold Form 5 Deferred for Firm has submitted an Deferred for
Laboratories & Flu Syrup Fast Track confirmation inspection report by confirmation
(Private) Each 5 ml 27-07-10 of area FID and a letter controlled drug section
Limited. contains Rs 8000/- manufacturin from ADC (Licensing) from Licensing
LC-41, Chlorphenamine 22-05-13 g facility of declaring approved Division.
L.I.T.E Maleate BP 1 Rs. 60,000/- Controlled liquid section.
Landhi, mg 120 ml Drug Firm has not
Karachi. Pseudoephedrine As per PRC submitted any
HCL USP 15 mg evidence of approval
(Antihistamine of manufacturing
Nasal facility of controlled
decongestant) drugs.
USP
Specifications
223. M/s Opal Oplamanic- Form 5 Deferred for Firm has submitted an Deferred for
Laboratories Cough Fast Track confirmation inspection report by confirmation
(Private) Syrup 27-07-10 Rs of area FID and a letter controlled drug section
Limited. Each 5 ml 8000/- manufacturin from ADC (Licensing) from Licensing
LC-41, contains 22-05-13 g facility of declaring approved Division.
L.I.T.E Dextromethorpha Rs. 60,000/- Controlled liquid section.
Landhi, n Hydrobromide 120 ml Drug Firm has not
Karachi. BP 10 mg+ As per PRC submitted any
Pseudoephedrine evidence of approval
HCL USP 30 of manufacturing
mg facility of controlled
160
(Antihistamine drugs.
Nasal
decongestant)
Manufacturer
Specifications
224. M/s Opal Opephyle-Cough Form 5 Deferred for Firm replied that Deferred for review of
Laboratories Syrup Fast Track review of product is already in formulation by review
(Private) Each 5 ml 27-07-10 Rs formulation market. committee.
Limited. contains 8000/- by Review
LC-41, Acefylline 24-05-13 committee
L.I.T.E Piperazine 45 mg Rs. 60,000/-
Landhi, + 120 ml
Karachi. Diphenhydramin As per PRC
e
HCL BP 8 mg
(Antihistamine
Bronchodilator)
Manufacturer
Specifications
225. M/s The Ventek Plus Form 5 Deferred for Firm has not replied of Deferred for last
Searle Tablets Fast Track last reminder final reminder. reminder.
Company Each tablet 31-05-12 Rs for
Limited. contains 8000/- submission
F- 319, Montelukast 13-05-13 of differential
S.I.T.E. 10mg + Rs. 60,000/- fee alomg
Karachi. Levocetrizine with Form
Dihydrochloride 5D.
5mg Formulation
Manufacturer is under
Specifications review
161
S/N Name and Brand Name Type of Decision in Remarks on the Decision
address of (Proprietary name Form M-243 formulation (if
manufacturer + Dosage Form + any) including
/ Applicant Strength) Initial date, International status
diary in stringent drug
Composition regulatory agencies
Pharmacological Fee / authorities
Group including
differential Me-too status
Finished product fee GMP status as
Demanded inspection report
Price / Pack (with date) by the
size Evaluator
226. M/s Hiranis Ferrital Form-5 Deferred for Me too has been Approved.
Pharmaceutica Capsule 16-12-2013 me too status confirmed as
l Pvt. Ltd. Each capsule Dy.No. Ferricure Capsule
Plot.No. E- contains:- 2062 150 mg (Reg No
145-149, Polysaccharide-Iron 16-12-2013 050637) of M/s
North western Complex eq. to Rs.20,000/- Continental Pharma
Industrial Elemental Iron MS As per PRC
Zone, Port 150mg
Qasim, (Iron Supplement)
Karachi. Finished product
(Tablet specifications are
General) Manufacturer
227. -do- Curadent Form-5 Deferred for Me too has been Approved.
Mouth Wash Mouthwash 22-10-2013 me too status confirmed as
(General) Each ml contains:- Dy.No. 914 Methaclor
Chlorhexidine 22-10-2013 Mouthwash (Reg No
Gluconate (BP) 0.2 Rs.20,000/- 061455) by M/s
mg As per PRC Delux Chemical
0.2% w/v Industries
Sodium Fluoride
(BP) 0.5mg
0..5% w/v
(Anti-bacterial/
Antiseptic)
228. -do- Benzicept Form-5 Deferred for Me too has been Approved.
Mouth Wash Mouthwash 06-02-2014 me too status confirmed as
(General) Each 100ml Dy.No. 36 Benzirin C
contains:- 06-02-2014 Mouthwash (Reg No
Benzydamine HCl Rs.20,000/- 047375) by M/s
BP 0.15gm As per PRC Adamjee Pharma
Cetylpyridinium
Choloride. BP
0.05gm
NSAID+Antiseptic
Finished product 162
specifications are
Manufacturer
Tooth Paste Tooth Paste 22-10-2013 me too status confirmed as Clinica
(General) Each gm Contains:- Dy.No. 913 0.2% tooth paste
Chlorhexidine 22-10-2013 (Reg No 024857) by
Gluconate 0.2 mg Rs.20,000/- M/s Platinum
0.2% w/w As per PRC Pharmaceutical and
(Anti-bacterial/ Hexadent tooth
Antiseptic) paste (Reg No
Finished product 061290)
specifications are
Manufacturer.
230. -do- Texadent Form-5 Deferred for Me too has been Approved.
Tooth Paste Tooth Paste 22-10-2013 me too status confirmed as Hi Salz
(General) Each gram Dy.No. 911 tooth paste (Reg No
contains:- 22-10-2013 (020857) by M/s
Sodium Chloride Rs.20,000/- Platinum
B.P 160mg 16% As per PRC Pharmaceutical and
w/w Prosalz tooth paste
Tranexamic Acid (Reg No 061289
B.P 0.5 mg 0.05%
w/w
(Stokatologicals,
Dentifrics,
Haemostatic
Fibronolytic)
Finished product
specifications are
Manufacturer.
Cream / Gel 22-10-2013 me too status confirmed now as
Ointment/ Contains:- Dy.No. 912 Clinica Gel 0.2%
Gel (General) Chlorhexidine 22-10-2013 (Reg No 025084) by
Gluconate BP Rs.20,000/- M/s Platinum
0.2%w/w As per PRC Pharmaceutical
(Anti-bacterial/
Antiseptic)
Finished product
specifications are
BP
232. -do- Tacrozemus 0.1% Form-5 Deferred for Firm has replied that Deferred for
Cream / Ointment 06-02-2014 clarification similar formulations clarification whether
Ointment/ Each gm Contains:- Dy.No. 42 that whether have been registered separate manufacturing
Gel (General) Tacrolimus (as 06-02-2014 separate and being facility is required for
Monohydrate) USP Rs.20,000/- manufacturing manufactured in immunosuppressant or
1mg As per PRC facility is General Cream/ otherwise
163
(Macrolide, required for Ointment section of
Immuno immunosuppr competitors.
modulating agent) esent or
Finished product otherwise.
specifications are
Manufacturer
233. -do- Tacrozemus 0.03% Form-5 Deferred for Firm has replied that Deferred for
Cream / Ointment 06-02-2014 clarification similar formulations clarification whether
Ointment/ Each gm Contains:- Dy.No. 32 that whether have been registered separate manufacturing
Gel (General) Tacrolimus (as 06-02-2014 separate and being facility is required for
Monohydrate) USP Rs.20,000/- manufacturing manufactured in immunosuppressant or
0.3mg As per PRC facility is General Cream/ otherwise
(Macrolide, required for Ointment section of
Immunomodulating immunosuppr competitors.
agent) esent or
Finished product otherwise.
specifications are
Manufacturer
234. -do- DENTAMAX Form-5 Deferred for Me too has been Approved.
Ointment Dental Paste 22-10-2013 confirmation confirmed as
/Gel/ Cream Each gm contains Dy.No. 915 of me too Combident Paste
Steroids Demeclocycline 22-10-2013 status. (Reg No (067665).
HCl USP 30.00mg Rs.20,000/-
Triamcinolone As per PRC
acetonide USP
10.00mg
(Stomatologicals,
Dentifrices)
Finished product
specifications are
Manufacturer.
235. -do- Terzhinan Vaginal Form-5 Deferred for Me too has been Approved.
Tablet Tablet 06-02-2014 confirmation confirmed as
Steroides Each tablet Dy.No. 34 of me too Tergynan Vaginal
contains:- 06-02-2014 status Tablet (Reg No
Ternidazole MS Rs.20,000/- 022374) but M/s
200mg As per PRC Highnoon
Neomycin Suphate Laboratories,
USP 100mg Pakistan
Nystatin USP
100000units
Prednisolone USP
3mg
(Antimicrobial,
anti-inflammatory,
anti-protozoa and
anti-fungal)
236. -do- Avogel Gel Form-5 Deferred for Me too has been Approved.
Cream / Dental Gel 06-03-2014 confirmation confirmed as
Ointment/ Each gram Dy.No. 215 of me too Ravomet Gel
164
Gel (General) contains:- 06-03-2014 status 1%w/w (Reg No
Metronidazole Rs.20,000/- 061286) by M/s
Benzoate eq to As per PRC Zanctok
Pharmaceutical
Metronidazole BP
10 mg
1%w/w
(Anti bacterial)
Finished product
specifications are
BP.
237. -do- Relever ointment Form-5 Deferred for Mycitracin Plus Approved.
Cream / Ointment 06-03-2014 me too status Ointment contains
Ointment/ Each gram contains Dy.No. 208 Me too has Lidocaine in same
been strength (Reg No
Gel (General) Bacitracin USP 500 06-03-2014
confirmed as 014863) by M/s
Units Rs.20,000/- Pfizer
Neomycin as Rs. 80 per
Sulphate USP 20 gram
3.5mg
Polymixin B
Sulphate USP 5000
Unots
Lidocaine USP
40mg
Finished product
specifications are
USP.
238. -do- Dentassium Mouth Form-5 Deferred for Firm has submitted Deferred till decision
Mouth Wash Wash 06-03-2014 clarification of revised formulation by the committee on
(General) Mouth Wash Dy.No. 206 following and removed the similar cases (M/s
observation. observation. Attabak).
Each ml contains:- 06-03-2014
Potassium Nitrate Rs.20,000/- 1. The
BP 10 mg As per PRC applicant has
(Desensitizing) mentioned
Vitamin B5 &
Finished product Vitamin E as
specifications are inactive
ingredients
Manufacturer.
while these
have
pharmacologic
al actions and
their use as
inactive
ingredient or
as excipients
requires
165
scientific
justification.
239. -do- Oradent Tooth Form-5 Deferred for Firm has submitted Deferred till decision
Tooth Paste Paste 06-03-2014 clarification of revised formulation by the committee on
(General) Each gram Dy.No. 205 following and removed the similar cases (M/s
observation. observation. Attabak).
contains:- 06-03-2014
Permethol 2.5mg Rs.20,000/- 1. The
(Analgesic, Anti As per PRC applicant has
inflammatory) mentioned
Vitamin B5 &
Finished product Vitamin E as
specifications are inactive
ingredients
Manufacturer.
while these
have
pharmacologic
al actions and
their use as
inactive
ingredient or
as excipients
requires
scientific
justification..
240. -do- Dentassium Tooth Form-5 Deferred for Firm has submitted Deferred till decision
Tooth Paste Paste 06-03-2014 clarification of revised formulation by the committee on
(General) Each gram Dy.No. 204 following and removed the similar cases (M/s
contains:- 06-03-2014 observation. observation. Attabak).
Potassium Nitrate Rs.20,000/- 1. The
BP 50 mg As per PRC applicant has
(Desensitizing) mentioned
Finished product Vitamin B5 &
specifications are Vitamin E as
Manufacturer. inactive
ingredients
while these
have
pharmacologic
al actions and
their use as
inactive
ingredient or
as excipients
requires
scientific
justification..
166
241. -do- Safcort Oral Form-5 D Deferred for Firm has submitted Deferred for expert
Liquid Syrup Suspension 04-03-2014 safety & safety & clinical evaluation by:
(Steroid) Oral Suspension Dy.No. 221 clinical trial trial data 1. Dr. Jamal Zafar,
Each 5 ml contains 04-03-2014 data PIMS
2. Syed Irfan, Benazir
Deflazacort 6mg Rs.50,000/- Bhutto Hosp.
(Glucorticosteroid) Rs. 120/ 30 3. Dr. Ayesha Amir,
Finished product ml Assist. Prof. Army
specifications are Medical College.
USP Medicine 1. D
Compendium r
242. -do- Safcort Tablet Form-5 D Deferred for Firm has submitted Deferred for expert
Tablet Tablet 04-03-2014 submission of safety & clinical evaluation by:
Steroides Each Tablet Dy.No. 186 safety & trial data 1. Dr. Jamal Zafar,
clinical data PIMS
contains 04-03-2014
2. Syed Irfan, Benazir
Deflazacort 6mg Rs.50,000/- Bhutto Hosp.
(Glucorticosteroid) Rs. 180/
3. Dr. Ayesha Amir,
Finished product 10s pack Assist. Prof. Army
specifications are Medical College.
USP MC
243. -do- Oracure Form-5 D Deferred for Firm has submitted Deferred for expert
Mouth Wash Mouthwash 06-03-2014 safety & safety & clinical evaluation by
(General) Mouthwash Dy.No. 36 clinical trial trial data Commandant AFID,
data Dept of Dentistry PIMS
Each 100ml 06-03-2014
and FGSH
contains:- Rs.50,000/-
Diclofenac acid BP Rs 200/ 150
0.074gm ml
(NSAID) Rs 266/ 200
Finished product ml
specifications are
Manufacturer
244. -do- Helenil Mouth Form-5 D Deferred for Firm has submitted Deferred for expert
Mouth Wash Wash 04-03-2014 safety & safety & clinical evaluation by
(General) Mouth Wash Dy.No. 206 clinical trial trial data Commandant AFID,
Each ml contains:- 04-03-2014 data Dept of Dentistry PIMS
and FGSH
Ketoprofen (as Rs.50,000/-
lysine salt) 16mg Rs 250/
(NSAID) 150ml
Finished product
167
specifications are
Manufacturer.
245. -do- Pentadent Form-5 D Deferred for Firm has submitted Deferred for expert
Mouth Wash Mouthwash 06-03-2014 safety & safety & clinical evaluation by
(General) Mouthwash Dy.No. 36 clinical trial usage data but not Commandant AFID,
data clinical trial data Dept of Dentistry PIMS
Each ml contains:- 06-03-2014
and FGSH
Benzydamine HCL Rs.50,000/-
BP 1.5 mg Rs 200/ 150
Hexetidine BP 1mg ml
(NSAID &
Antiseptic)
Finished product
specifications are
Manufacturer
246. -do- Dentisept Tooth Form-5 D Deferred for Firm has not Deferred for expert
Tooth Paste Paste 06-03-2014 submission of submitted clinical evaluation by
(General) Each gram Dy.No. 213 safety & trial data Commandant AFID,
clinical trial Dept of Dentistry PIMS
contains:- 06-03-2014
data and FGSH
Benzydamine HCL Rs.20,000/
BP 5 mg 75 g plastic
(Analgesic, Anti tube Rs
175/-
inflammatory)
Finished product
specifications are
Manufacturer.
247. -do- INFEXO DS Form-5 Deferred for Firm has applied for Deferred for providing
Dry Powder Dry Suspension 24-10-2013 confirmation / Ciprofloxacin source of
Suspension Each 5ml contains: Dy.No. 933 clarification of microcapsules and microcapsules, GMP of
(General). Ciprofloxacin USP 24-10-2013 formulation. submitted a revised Source, Stability
250mg Rs.20,000/- formulation. studies, COA and fee
(Quinolones) 60ml/ As Firm claimed that (in case of import).
Finished product per PRC similar formulation
specifications are has been approved
Manufacturer of various applicants
in M 243 based on
microcapsule
ciprofloxacin
formulation.
248. -do- INFEXO Form-5 Deferred for Firm has applied for Deferred for
Dry Powder Dry Suspension 16-12-2013 confirmation Ciprofloxacin confirmation of
Suspension Each 5ml contains: Dy.No. 209 of approval of microcapsules and international
(General). Ciprofloxacin USP 16-12-2013 formulation in submitted a revised availability.
125mg Rs.20,000/- 125 mg formulation.
(Quinolones) As per PRC strength by Firm claimed that
Finished product Stringent similar formulation
specifications are Regulatory has been approved
Manufacturer Agencies. of various applicants
168
in M 243 based on
microcapsule
ciprofloxacin
formulation.
249. -do- Levopearl Form-5 Deferred for Firm has applied Deferred as
Dry Powder Dry Suspension 16-12-2013 confirmation formulation as Registartion Board has
Suspension Each 5ml contains:- Dy.No. of Levofloxacin Oral already granted 10
(General). Levofloxacin USP 2067 formulation. Solution 125 mg/ 5 products in Liquid
125 mg 16-12-2013 ml and submitted syrup section (General)
Quinolone Rs.20,000/- revised formulation
Finished product As per PRC and analytical
specifications are methods for oral
Manufacturer. solution.
250. -do- Levopearl -DS Form-5 Deferred for Firm has applied Deferred for
Dry Powder Dry Suspension 16-12-2013 confirmation formulation as confirmation of
Suspension Each 5ml contains:- Dy.No. of Levofloxacin Oral formulation for
(General). Levofloxacin USP 2059 formulation. Solution 125 mg/ 5 international
250 mg 16-12-2013 ml and submitted availability.
Quinolone Rs.20,000/- revised formulation
Finished product As per PRC and analytical
specifications are methods for oral
Manufacturer. solution.
Levofloxacin oral
solution has not
been approved as
250 mg/ 5 ml by
FDA.
251. -do- Myotec Form-5 Deferred for Internationally Deferred for me too
(Tablet Tablet 16-12-2013 international product is available status and provision of
General) Each sugar coated Dy.No. availability in china, Japan, documents regarding
tablet 2061 status India with brand international
contains: 16-12-2013 name as Myonal availability
Eperisone HCl MS Rs.20,000/- Tablet
50mg As per PRC
(Antispasmodic)
Manufacturer
Specifications
169
b) Deferred Cases of M-243rd meeting of Registration Board
Evaluator V
Sr. Name and Brand Name Type of Form Decision taken Remarks on the Decision
No. address of (Proprietary Initial date, diary in the 242nd formulation (if
Manufacturer / name + Dosage Fee including meeting by the any) including
Applicant form + Strength) differential fee Registration International
Composition Demanded Price Board status in
Pharmacological / Pack size stringent
Group regulatory
Finished product agencies /
specification authorities
Me-too status
GMP status as
depicted in
inspection report
(dated)
252. M/s. P.D.H Giostatin 10mg Form 5 Deferred for 1. An undertaking Deferred for final
Pharmaceuticals Tablets Fast Track final reminder / commitment reminder for
(Pvt) Ltd., 19 for completion regarding the submission of
Km, Ferozepur Each film coated 12/4/2013 798 of Form 5 submission of reply.
Road, Lahore. tablet contains:- R&I following, as per
Rosuvastatin 13/11/2013 decision of the
Calcium equivalent (Rs. 60,000/-) Registration
to Board, may be
Rosuvastatin.10 Rs.250/10s submitted:
mg a) Label
claim and
Statins prescribing
information being
Manufacturers same as approved
specifications by reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA and
Health Canada.
2. Several
observations have
been made by the
area FID in the
inspection report
dated 05/03/2014
regarding
validation of
HVAC, frequency
of In Process
testing, differential
pressure
170
maintenance, old
machinery like
fluid bed dryer,
mixer, granulator
to be replaced
with latest version
etc.
General Tablet /
General Capsule
section mentioned
in FID report
dated 05/03/2014
Inspection report
dated 05/03/2014
provided.
CRESTOR 10mg
US FDA
253. M/s. P.D.H Esogerd 20mg Form 5 Deferred for 1. An undertaking Deferred for final
Pharmaceuticals Capsule Fast Track final reminder / commitment reminder for
Km, Ferozpur Enteric coated 12/11/2013 788 of Form 5 submission of reply.
Road, Lahore. pellets R&I following, as per
Each capsule 12/11/2013 decision of the
contains:- (Rs. 60,000/-) Registration
Esomeprazole Board, may be
Magnesium submitted:
trihydrate enteric Rs.231/ 2x7s a) Label
coated pellets claim and
equivalent to prescribing
Esomeprazole20 information being
mg same as approved
by reference drug
Anti-ulcer agencies e.g.,
FDA, TGA,
Manufacturers MHLW, EMA and
specifications Health Canada.
2. Several
Source: Vision observations have
Pharmaceuticals been made by the
Islamabad area FID in the
inspection report
dated 05/03/2014
regarding
validation of
HVAC, frequency
of In Process
pressure
171
maintenance, old
machinery like
fluid bed dryer,
mixer, granulator
to be replaced
with latest version
etc.
General Tablet /
General Capsule
section mentioned
in FID report
dated 05/03/2014
Inspection report
dated 05/03/2014
provided.
NEXIUM
20mg Delayed
Release Capsules
US FDA
254. M/s. P.D.H Esogerd 40mg Form 5 Deferred for 1. An undertaking Deferred for final
Pharmaceuticals Capsule Fast Track final reminder / commitment reminder for
Km, Ferozpur Enteric coated 12/11/2013 788 of Form 5 submission of reply.
Road, Lahore. pellets R&I following, as per
Each capsule 12/11/2013 decision of the
contains:- (Rs. 60,000/-) Registration
Esomeprazole Board, may be
Magnesium submitted:
trihydrate enteric Rs.360/ 2x7s a) Label
coated pellets claim and
equivalent to prescribing
Esomeprazole40 information being
mg same as approved
by reference drug
Anti-ulcer agencies e.g.,
FDA, TGA,
MHLW, EMA and
Manufacturers Health Canada.
specifications 2. Several
observations have
Source: Vision been made by the
Pharmaceuticals area FID in the
Islamabad inspection report
dated 05/03/2014
regarding
validation of
HVAC, frequency
of In Process
172
pressure
maintenance, old
machinery like
fluid bed dryer,
mixer, granulator
to be replaced
with latest version
etc.
General Tablet /
General Capsule
section mentioned
in FID report
dated 05/03/2014
Inspection report
dated 05/03/2014
provided.
NEXIUM
40mg Delayed
Release Capsules
US FDA
255. M/s. P.D.H. Pyrox-B Tablets Form-5 Deferred for 1. An undertaking Deferred for final
Pharmaceuticals, Fast Track final reminder / commitment reminder for
Lahore Each tablet for completion regarding the submission of
contains:- 28/8/2013 9991 of Form 5 submission of reply.
Piroxicam Beta R&I following, as per
Cyclodextrin 28/8/2013 decision of the
equivalent to (Rs. 60,000/-) Registration
Piroxicam..20 Board, may be
mg Rs.265.22 per submitted:
2x10s a) Label
(NSAID) claim and
prescribing
Manufacturers information being
specifications same as approved
by reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA and
Health Canada.
2. Several
observations have
been made by the
area FID in the
inspection report
dated 05/03/2014
regarding
validation of
173
HVAC, frequency
of In Process
pressure
maintenance, old
machinery like
fluid bed dryer,
mixer, granulator
to be replaced
with latest version
etc.
General Tablet /
General Capsule
section mentioned
in FID report
dated 05/03/2014
Inspection report
dated 05/03/2014
provided.
BREXIDOL
(BNF)
174
Case No.09. Registration Applications for Human import.
Evaluator-IV
S.No Name and Brand Name Type of Form Remarks on the Decision
address of (Proprietary name + formulation (if any)
manufacturer/ Dosage Form + Initial date, diary including
Applicant Strength) International status in
Fee including stringent drug
Composition differential fee regulatory agencies /
authorities
Pharmacological Demanded Price /
Group Pack size Me-too status

inspection report
(with date) by the
Evaluator
234. Applicant: Essentiale Fort Form 5-A International: available Deferred for expert
M/s. Sanofi- Capsule 300mg 11-03-2009 in Germany, France opinin of Dr.Huma
Aventis Pakistan Each capsule Diary No. 115 Local: New Drug Qureshi, Syed Irfan,
Ltd Karachi. contains: - According to GMP Benazir Bhutto Hosp
Rs.15000 + 85000
Manufacturer: Phospholipids from certificate, firm and Dr.Janbaz,
A. Natterman & Demanded complies with good Pharmacy, BZU,
soya beans Price/Pack Size
Cie. GmbH manufacturing practice. Multan.
(Sanofi group)
containing 76% (3- Rs.800/Bottle Pack of
Nattermannallee sn-phosphatidyl) 100 Capsules
1 D-50829 Choline 300
Cologne: mg
Germany (Hepatoprotectives)
235. Applicant: Cefpran DS 3 g Form 5-A International: not Deferred for
M/s Ontech Injection 08-04-2009 approved by reference confirmation of
Corporation Each injection DRAs international availability.
B- 90 Block 10 contains 15000 + 85000 Local: New Drug, Not
Gulshan e Iqbal, Cefoperazone registered in 3 G
Karachi. Sodium.2.3 g 1 vial in one pack strength
Manufacturer: Sulbactam Rs. 811.96/ box DSL has been expired.
M/s NCPC Sodium..1.2 g
Hebei Huamin (Antibiotic)
Pharmaceitical
co., Ltd. Finished product
No. 98 Hainan specifications are
Road, Economic Manufacturer.
& Technological
Development 175
Zone,
Shijiazhuang,
China
236. Applicant: ZinCfant 20mg Form 5-A International: The Approved as per import
M/s. Prism Dispersible Tablet 18-04-2009 formulation is WHO policy.
Health Each tablet contains: - 15000 + 85000 recommended.
Pakistan Karachi Rs.9.50/ Local: Zinkley
54.9mg zinc Sulphate
/ Per Tablet dispersible tablet by
Manufacturer: Monohydrate (eq to High Q
Rs.950/
M/s. Laboratoire 20mg Elemental Zinc Applicant has provided
(Anti Diarrhoeal for 10 x 10 Tablets
Pharmaceutique GMP certificate of
Rodael 1 route Paediatric) manufacturer abroad,
de Socx ZAC du valid up to 30
Bierendyck et de September 2014.
la Croix Rouge
Bierne, France
Product License
Holder
M/s. Nutriset
BP35 Le Bois
Ricard Malaunay
France.
237. Applicant: Meropeon Injection From 5-A International: Approved as per import
M/s Laderly Bio 0.5g 18-07-2009 Meropenem Inj 500 mg policy.
Tech Pharma. Each vial contains: - 15000 + 85000 (FDA)
803-A, Meropenem Demanded Local: Demonem 500
P.E.C.H.S., USP 0.5g Price/Pack Size As mg by Rotex Medica
Block-6 Shahra e (Broad Spectrum per leader price According to CoPP
Faisal, Karachi. submitted, facilities &
Antibiotic)
Manufacturer: operations of
M/s. Finished product manufacturer conform
CSPCPharmaceu specifications are to GMP as
tical Co, Ltd, No. USP. recommended by
188 Gongnong WHO.
Road, Applicant (Laderly Bio
Shijiazhuang Tech) has submitted
City, P R China. copy of NOC from
previous applicant
(Aeon Pharma) and
copy of letter of
authorization from
manufacturer.
238. Applicant: Meropeon Injection From 5-A International: Approved as per import
M/s Laderly Bio 1gm 18-07-2009 Meropenem Inj 1 g policy.
Tech Pharma. Each vial contains: - 15000 + 85000 (FDA)
803-A, Meropenem USP Demanded Local: Demonem 1 g
P.E.C.H.S., 1gm Price/Pack Size As by Rotex Medica
Block-6 Shahra e per leader price According to CoPP
(Broad Spectrum
Faisal, Karachi. submitted, facilities &
Manufacturer: Anti Biotic) operations of
M/s. Finished product manufacturer conform
CSPCPharmaceu specifications are to GMP as
tical Co, Ltd, No. USP. recommended by
188 Gongnong WHO.
176
Road, Applicant (Laderly Bio
Shijiazhuang Tech) has submitted
City, P R China. copy of NOC from
previous applicant
(Aeon Pharma) and
copy of letter of
authorization from
manufacturer.
239. Applicant: Azarga Eye Drop Form 5-A International: Azarga Deferred for expert
M/s. Ali Gohar Suspension 5ml 02-03-2010 eye drop (EMA) opinion of Prof.M.Daud
& Co. (Pvt) Ltd., Each ml contains:- 50, 000 Local: New Drug Khan, Maj Gen Mazhar
Karachi. / Brinzolamide......10mg Rs.1400/ 5ml eye According to COPP Ishaq and Prof.Ali Raza
Manufacturer: Timolol...............4mg drops packs issued by EMA,
M/s. S.A. Alcon- (Beta Blocking manufacturing facilities
Couvreur N.V. agents). conform to GMP as
Rijksweg 14, Finished product recommended by
2870 Puurs, specifications are WHO.
Belgium. Manufacturer.
177
Item No.VI: Miscellaneous cases.
Registration-I
Case No. 01 Registration of Surgical Sutures.
Drug Registration Board in its 237th meeting held on 26-02-2013 approved the
registration of the following Surgical Sutures applied M/s. Medicamp Distributors, Rawalpindi
subject to inspection of facilities of manufacturer abroad M/s. Shanghai Pudong Jinhuan Medical
Products Co. Ltd., China:-
S. No. Name of Products.

1. Milene Polypropylene Surgical Suture.
2. Micryl PGLA Surgical Suture.
3. Plain Catgut Surgical Suture.
4. Misilk Silk Surgical Suture.
5. Chromic Catgut Surgical Suture.
Meanwhile, M/s. A. Feroz & Co., Karachi have also applied for registration of following
Surgical Sutures from the same source / manufacturer M/s. Shanghai Pudong Jinhuan Medical
Products Co. Ltd., China and informed that the manufacturer abroad M/s. Shanghai Pudong
Jinhuan Medical Products Co. Ltd., China has appointed them their new sole distributor for
Pakistan for their all products and terminated the agreement with M/s. Medicamp Distributors,
Rawalpindi:-

1. Star PGA Suture (PGLA Suture- Poly (glycolide-co lactide) (90/10).
2. Star PGA Suture (PGA (Polyglycolicacid) Suture.
3. Star Polyester Suture (Polyester Suture).
4. Star Silk Suture (Silk Suture).
5. Star Nylon Suture (Nylon Suture).
6. Star Polypropylene Suture (Polypropylene Suture).
7. Star Plain Catgut Suture (Plain Catgut Suture).
8. Star Chromic Catgut Suture (Chromic Catgut Suture).
M/s. A. Feroz & Co., Karachi has therefore requested to consider their application for
registration of the above said Surgical Sutures. The firm has also submitted attested letter of sole
agency and termination letter for other agent, attested by Embassy of Pakistan.
178
M/s. Medicamp Distributors, Rawalpindi was advised to deposit the remaining fee as per
revised fee Schedule F and submit fresh agency agreement with the manufacturer i.e. M/s.
Shanghai Pudong Jinhuan Medical Products Co. Ltd., China legalized by the Pakistan Embassy
in China. M/s. Medicamp Distributors, Rawalpindi have not deposit the remaining fee as per
revised fee Schedule F and also not submitted fresh agency agreement with the manufacturer
abroad till date.
M/s. A. Feroz & Co., Karachi was also advised to deposit the remaining fee as per
revised fee Schedule F. In response, M/s. A. Feroz & Co., Karachi have deposited the remaining
fee for the following 07 products out of 08 products and requested to drop dossier for the
registration of Star Plain Catgut Suture:-

1. Star PGLA Suture (Polyglycolide-co lactide).
2. Star PGA Suture (Polyglycolicacid).
3. Star Polyester Suture.
4. Star Silk Suture.
5. Star Nylon Suture.
6. Star Polypropylene Suture.
7. Star Catgut Chromic Suture.
M/s. Medicamp Distributors, Rawalpindi was again advised to deposit the remaining fee as per
revised fee Schedule F and submit fresh agency agreement with the manufacturer i.e. M/s.
Shanghai Pudong Jinhuan Medical Products Co. Ltd., China legalized by the Pakistan Embassy
in China. M/s. Medicamp Distributors, Rawalpindi have not deposit the remaining fee as per
revised fee Schedule F and also not submitted fresh agency agreement with the manufacturer
abroad despite reminder.
The cas was placed before the Registration Board and it was decided to call the firm M/s.
Medicamp Distributors Rawalpindi for personal hearing.
Decision: The representative of M/s. Medicamp Distributors Rawalpindi (Ch. Arif

Hussain) appeared before the Board and informed that the principal company M/s.
Shanghai Pudong Jinhuan Medical Products Co. Ltd., China has terminated their sole
agency agreement but they are trying to renegotiate with them. The Board asked him to
submit new agreement with in reasonable time for which he showed his inability. After
179
discussion Registration Board decides to amend its earlier decision took in 237 th meeting
and rejected the following applications of M/s. Medicamp Distributors Rawalpindi.

1. Milene Polypropylene Surgical Suture.
2. Micryl PGLA Surgical Suture.
3. Plain Catgut Surgical Suture.
4. Misilk Silk Surgical Suture.
5. Chromic Catgut Surgical Suture.
Registration Board decided that applications of M/s. A. Feroz & Co., Karachi will
be considered on its turn and advised to provide updated agreement in its name from the
manufacturer aboard.
Case No. 02. Correction in composition of registered veterinary drugs.
M/s. Myrtle Pharma, Karachi have requested for correction in composition of their
registered veterinary drugs as these were erroneously registered against their request in the
product dossier submitted to DRAP. They have requested that following correction may kindly
be made in their registration letter:-
S# Reg. Name of Incorrect (written in the Correct (submitted in the product

No. Drug. registration letter). dossier).
1 072603 Myovit Oral Myovit Oral Powder. Myovit Plus
Powder. Each 1000gm contains:- Each 1000gm contains:-
Vitamin A . 20000000 IU. Vitamin A . 20000000 IU.
Vitamin D . 40,00000 IU. Vitamin D . 40,00000 IU.
Vitamin E .. 1600 IU. Vitamin E .. 1600 IU.
Vitamin K . 9000mg. Vitamin K . 9000mg.
Vitamin B1 1250mg. Vitamin B1 1250mg.
Vitamin B12 30000mcg. Vitamin B12 30000mcg.
Vitamin C 10,000mcg. Vitamin C 10,000mg.
Folic Acid 2000mcg. Folic Acid 2000mcg.
Nicotinamide Nicotinamide 30,000mg.
100000mcg. Calcium D Pantothenate 3000mg.
Calcium D Pantothenate Biotin . 20,000mcg.
3000mg.
Biotin . 20,000mg.
2 072613 Myo-Sel Each 1000gm contains:- Each 1000gm contains:-
180
Premix Vitamin E . 150gm. Vitamin E . 150gm.
Selenium Selenium 150mg.
150gm.
3 073957 MYO CTC Each 1000gm contains:- Each 1000gm contains:-
Oral Powder. Chlortetracycline 250gm. Chlortetracycline 75gm.
Neomycin Sulphate 100gm. Neomycin Sulphate 40gm.
Furltadone ............ 250gm. Furltadone ............ 30gm.
4 072607 Myrobac 50ml 500ml

Oral Liquid. 100ml 1000ml
5 072608 Myrtleflox Each 100ml contains:- Each 100ml contains:-

Oral Liquid. Enrofloxacin . 20gm. Enrofloxacin . 20gm.
Colistin Sulphate 2,00,000 Colistin Sulphate 50000000 IU.
IU.
6 072610 Myrtrovit Each ml contains:- Each ml contains:-
Oral Liquid. Vitamin A .. 100,000 Vitamin A .. 100,000 IU.
IU. Vitamin D3. 20,000 IU.
Vitamin D3. 20,000 IU. Vitamin E 20mg.
Vitamin E 20mg. Vitamin K ............ 20mg.
M/s. Myrtle Pharma, Karachi have deposited fee Rs.5000/each. The aforesaid
mistake/omission has not been verified from the registration applications submitted by the firm
at the time of registration.
The drugs mentioned in above were registered in 2011 & 2012, now firm has applied for
the correction of formulation after the lapse of about 3 years, which means they have not
manufacture these products which is violation of the condition of registration.
The record of these product is scrutinized from dossier submitted by the firm and found
the letter were issued according to the dossier submitted by the firm and no lacking at the part of
the Drug Regulatory Authority of Pakistan.
The cas was placed before the Registration Board and it was decided to call the firm for
personal hearing.
Decision: The representative of M/s. Myrtle Pharma, Karachi was called on for
personal hearing before the board but they have not appeared before the Registration
Board. The Board decides to issue final notice for personal hearing to the firm in its
forthcoming meeting.
181
Case No.03. Change of manufacturer name from M/s. Bayer Schering Pharma AG,
Germany to M/s. Bayer Pharma AG, Germany.
M/s. Medipharm (Private) Limited, Lahore have informed that due to a Bayer Group-
wide initiative to change the name of the pharmaceutical company, they have requested to
approved the change of the manufacturer name of their following registered imported drug as
follows:-
S# Reg. Name of Drug Current Name of Proposed Name of
No. (s) Manufacturing Manufacturing Site.
Site.
1. 010221 Androcur Manufactured by: Bulk Manufactured by:
Tablets 50mg. M/s. Delpharm lille M/s. Delpharm Lille S.A.S.,
SAS France. France.
Pack and Final Packaging and Final
release: release:
M/s. Bayer Schering M/s. Bayer Weimar GmbH
Pharma AG, und Co. KG, 99427 Weimar,
Germany. Germany.
Product License Holder:-
M/s. Bayer Vital GmbH,
51368 Leverkusen,
Germany.
M/s. Medipharm (Private) Limited, Lahore have deposited fee Rs.50000/- and submitted
following supporting documents:-
i) Copies of Registration letters.
ii) Notarized Declaration from their Princiapl regarding the Name Change from
Bayer Schering Pharma AG to Bayer Pharma AG.
iii) Original legalized CoPPs of Androcur 50mg Tablets.
iv) Copy of name change of company.
v) Copy of NOC for CRF.
M/s. Medipharm (Private) Limited, Lahore was advised to Provide fresh legalized CoPP
from France as manufacturing facility is located in France and status of license holders: -
In response, M/s. Medipharm (Private) Limited, Lahore have submitted fresh original
legalized CoPP of Androcur Tablets 50mg from Germany as there is a change in Pack & Final
release site located in Germany. They have further submitted that CoPP from France cannot be
issued as there is no change in manufacturing facility located in France.
182
The firm has not provided CoPP of French authority as the Androcur, is manufactured in
France and German authorities can not verify its GMP status.
The cas was placed before the Registration Board and it was decided to ask the firm for
submission of legalized COPP of the product from French regulatory authority. Now the firm has
submitted the legalized COPP.
Decision: Request of the firm was acceded to by Registration Board.
Case No. 04. Registration of imported veterinary drugs.

Drug Registration Board in its 237 th meeting held on 26-02-2013 approved the
registration of following imported veterinary drugs in the name of M/s. Better Traders
International, Faisalabad, manufactured by M/s. Kepro B.V. Maagdenburgstraat, Deventer,
Holland, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the differential fee Rs.85000x5=Rs.425000/-
S.#. Name of Drug (s) /Composition. Decontrolled / Shelf Life

Pack Size.
1. Tilmi 25% Oral Liquid. 100ml 02years
Each ml contains:- 250ml
Tilmicosin (as tilmicosin phosphate) 500ml
....... 250mg. 1 Liter
2.5 Liter
5 Liter
2. L.S. Water Soluble Powder. 100gm. 02years

Each gm contains:- 150gm.
Lincomycin HCI.222mg. 1000gm.
Spectinomycin HCI444mg.
3. L.S. Injection. 100ml. 02years

Each ml contains:-
Lincomycin (as HCI H2O) 50mg.
Spectinomycin (as HCI 5 H2O) 100mg.
4. Florum 10% Oral Solution. 1000ml. 02years

Each ml contains:-
Florfenicol.100mg.
183
Storage facility of the importer has already been verified by the Area FID.
The applicant M/s. Better Traders International, Faisalabad have requested for issuance
of registration letters of the above said drug.
As the above said products are not on free sale in Netherlands and are registered for
export purpose only. Therefore, M/s. Better Traders International, Faisalabad was advised to
clarify the same.
In response, M/s. Better Traders International, Faisalabad have submitted the detailed
information reply on the registration of veterinary medicines in Netherlands from their principal
M/s. Kepro B.V, Holland (Pages 11-12/Corr). Furthermore, firm have submitted that similar
products are already registered for local and import by the DRAP, even the imported products
are not registered in the country of origin. The disease challenges (threshold) are very high in
the country and good quality medicines are the need of the formers to meet these challenges.
Kepro products are result oriented and demand of the formers. M/s. Kepro B.V, Holland is a
European GMP company.
The firm M/s. Kepro B.V, Holland has accepted that these products referred above are
not registered in Netherlands due to less demands of antibiotics use in their country. The GMP
certificate provided by them also indicate they only have approval for batch certification of
products & not production, which is a questionable.
The case was placed before the Registration Board and was discussed matter of non-
availability of finished drug in country of origin. It was deliberated that finished drug
should be permitted for import only if it is free for sale in country of origin and it was
decided to call the firm for personal hearing.
Decision: The representative of M/s. Better Traders International, Faisalabad was

called on for personal hearing before the board but they have not appeared before the
Registration Board. The Board decides to issue final notice for personal hearing to the firm
in its forthcoming meeting.
184
Case No. 05. Transfer of Registration of Elidel Cream 1% (Reg. No.041165).
M/s. Martin Dow Pharmaceuticals Limited, Karachi have applied for transfer of
registration of registered imported drug Elidel Cream 1% (Reg. No.041165) from the name of
M/s. Novartis Pharma (Pakistan) Limited, Karachi to their name under License from M/s.
MEDA Pharma GmbH & Co. KG, Germany.
M/s. Martin Dow Pharmaceuticals Limited, Karachi have deposited the fee Rs.50000/ -
and submitted following supporting documents:-
i) Copy of registration letter.
ii) Coy of renewal letter.
iii) No Objection Certificate (NOC) from M/s. Novartis Pharma (Pakistan) Limited,
Karachi.
iv) Original Sole Agency Agreement between M/s. MEDA Pharma GmbH & Co.
KG, Germany and M/s. Martin Dow Pharmaceuticals Limited, Karachi.
v) Original legalized CoPP of Elidel Cream 1%.
vi) Application on Form 5-A.
M/s. Martin Dow Pharmaceuticals Limited, Karachi was advised to provide the following
documents:-
i) Status of the product approval from EMA, US FDA, TGA, Japan or WHO.
ii) CRF, NOC up-to 2012.
iii) Report on clinical trials in local condition, as advised in registration letter.
In response, M/s. Martin Dow Pharmaceuticals Limited, Karachi have submitted that
Elidel Cream 1% is registered in 112 countries including US FDA, Canada & TGA and
provided copy of approval from US-FDA, Germany & TGA. Firm have also provided copy of
CRF, NOC up-to 2012.
The previous importer M/s. Novartis Pharma (Pakistan) Limited, Karachi have submitted
the clinical trials conducted global and regional Clinical / Phase-IV Studies.
As Registration of Elidel Cream 1% (Reg. No.041165) was granted subject to clinical
trial within one year of registration and local contract manufacturing after two years. The firm
has not complied these conditions. Therefore, M/s. Martin Dow Pharmaceuticals Limited,
Karachi was advised to clarify their position why they have not complied the conditions of
registration.
185
In response, M/s. Martin Dow Pharmaceuticals Limited, Karachi have requested to
withdraw their application for transfer of registration of Elidel Cream 1% (Reg. No.041165)
from M/s. Novartis Pharma (Pakistan) Limited, Karachi to their name.
Registration of Elidel Cream 1% (Reg. No.041165) was granted subject to clinical trial
within one year of registration and local contract manufacturing after two years. M/s. Novartis
Pharma (Pakistan) Limited, Karachi have not complied these conditions. Therefore, M/s.
Novartis Pharma (Pakistan) Limited, Karachi was advised to clarify their position why you have
not comply the conditions of registration.
In response, M/s. Novartis Pharma (Pakistan) Limited, Karachi have submitted that in
continuation to a request from M/s. Martin Dow Pharmaceuticals Limited, Karachi dated 13 th
March, 2013 to transfer this product from M/s. Novartis Pharma (Pakistan) Limited, Karachi
following a mutual agreement between their principals. Unfortunately, this transfer could not be
granted by Drug Regulatory Authority of Pakistan during last one year despite of its worldwide
transfer. Consequently, the principal offices have to cancel their agreement and revert their
decision in Pakistan only.
M/s. Martin Dow Pharmaceuticals Limited, Karachi has now informed DRAP about their
decision to withdrawal of this request. Therefore, they have now request to kindly condone this
request for the transfer of registration and also consider this as withdrawal of their registration.
M/s. Novartis Pharma (Pakistan) Limited, Karachi has not fulfill the condition of
registration of Elidel Cream 1% as recorded above and now they have informed to this office that
they want to withdraw their registration. This is a lacking on the part of the firm for not honoring
the local regulatory authorities.
There is no alternate of the Elidel Cream (Pimecrolimus) is available in Pakistan.

Therefore, it is propose that firm may be directed to make arrangement for local manufacturing
of the product or given this brand name to any other company for marketing in Pakistan.
The case was placed before the Registration Board and it was decided to call the firm for
personal hearing.
186
Decision: Dr. Ahson Siddiqi along with his team appeared before the Board and
informed that they have not launched the product in Pakistan due to low MRP, thus firm
has not conducted the indigenous clinical trial. The Board after deliberations accepted
request of the firm for de-registration of Elidel Cream 1% (Reg. No.041165).
Case No. 06. Termination of agreement.
M/s. Genome Pharmaceuticals (Pvt) Ltd., Rawalpindi have requested for transfer of
registration of the following registered imported blood bags from the name of previous agent
M/s. 3H Hoffmann Human Health Pakistan Ltd., Lahore to their name as the manufacturer
abroad M/s. Shandong Weigao Group Medical Polymer Co. Ltd., China has terminated the
agency agreement of the previous agent and appointed them as new agent in Pakistan for these
products:-
S. No. Reg. No. Name of Products

1. 033123 Single Disposable Blood Bag (CPDA Solution)
with Transfusion Set.
2. 033124 Double Disposable Blood Bag (CPDA Solution)
3. 033125 Triple Disposable Blood Bag (CPDA Solution)
The applicant M/s. Genome Pharmaceuticals (Pvt) Ltd., Rawalpindi have deposited fee
Rs.50000x3=150000/= and submitted following supporting documents:-
i) Termination of Agreement of Previous Agent.

ii) Authorization of New Sole Distribution of the New Agent
M/s. Genome Pharmaceuticals (Pvt) Ltd., Rawalpindi was advised to provide NOC of the
former agent M/s. 3H Hoffmann Human Health Pakistan Limited, Lahore regarding transfer of
registration of the above said products. In response, M/s. Genome Pharmaceuticals (Pvt) Ltd.,
Rawalpindi have not provided NOC of the former agent.
The previous agent M/s. 3H Hoffmann Human Health Pakistan Ltd., Lahore was advised
to clarify that as the manufacturer abroad M/s. Shandong Weigao Group Medical Polymer Co.
Ltd., China has terminated the agency agreement with you for the products.
187
In response, M/s. 3H Hoffmann Human Health Pakistan Ltd., Lahore intimated that they
have serious reservation on the decision by the M/s. Shandong Weigao Group Medical Polymer
Co. Ltd., China. The matter Termination of Agreement is under discussion with M/s.
Shandong Weigao Group Medical Polymer Co. Ltd., China and it is hoped that the matter will be
resolved very soon and business relation will be continued further after getting satisfactory
response from M/s. Shandong Weigao Group Medical Polymer Co. Ltd., China. Therefore they
have requested to wait for further processing in the matter and oblige.
The case was placed before the Registration Board and it was decided to call the firm
M/s. 3H Hoffmann Health Pakistan Ltd., Lahore for personal hearing.
Decision: Col. (R) J Zahoor CEO of M/s. 3H Hoffmann Human Health Pakistan Ltd.,
Lahore appeared before Registration Board and informed they discontinued the import of
blood bags from M/s. Shandong Weigao Group Medical Polymer Co. Ltd., China as firm
received complaints from different institutions about quality of these blood bags.
Resultantly manufacturer is now changing their local agent.
The Board took serious notice of matter and decided that the case should be
thoroughly investigated by the area FID Lahore and report be placed in forthcoming
meeting for decision.
Case No. 07. Change of manufacturing site of Galvus Met 50/500mg Tablets (Reg.
No.078106).
M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change
of manufacturing site of their registered imported drug Galvus Met 50/500mg Tablets (Reg.
No.078106) as follows:-
Reg. No. Name of Product. Existing Manufacturing Site New Manufacturing Site /
/ Product Licence holder. Product Licence holder.
188
078106 Galvus Met Manufactured by:- M/s. Manufactured by:
50/500mg Novartis Pharma Stein AG, M/s. Norartis Pharma
Tablets. Schaffhauserstrasse 4332 Produktions GmbH, Oflinger
Each tablets Stein AG, Switzerland / Str. 44, 79664 Wehr, Baden-
contains:- Product licence holder:- Wurttemberg, Germany.
Vildagliptin M/s. Novartis Pharma Product licence holder:- M/s.
50mg. Schweiz AG, Novartis Pharma GmbH,
Metformin Monbijoustrasse 118, 3007 Roonstrasse 25, 90429
hydrochloride Bern, Switzerland. Nurnberg, Germany.
500mg.
M/s. Novartis Pharma (Pakistan) Limited, Karachi have deposited required fee
Rs.100000/- and submitted following supporting documents:-
i) Original legalized GMP Certificate of new manufacturing site.

ii) Copy of product registration letter.
iii) Original legalized German CPP mentioning new manufacturing site.
iv) Application on Form-5 (A).
v) Site Master File.
vi) Copy of NOC for CRF.
Registration of the drug is valid.
The CoPP provided by the firm issued by German authorities indicates that the product is
neither authorized to be placed on German market nor on free sale in country of origin i.e.
Germany.
There are other similar pending cases with same status of product. This required across
the board decision by Registration Board.
The case of non-availability of finished drug in country of origin and after deliberation of
the fact that finished drug should be permitted for import only if it is for free sale in
country of origin. Thus the Board decided to call firm,s representatives for presentation
of their case in next meeting.
Decision: Dr. Ahson Siddiqi along with his team appeared and informed that the
product is not on free sale in country of origin due to commercial reasons but the product
manufactured from the same facility i.e. M/s. Novartis Pharma Produktions GmbH, Oflinger
Str. 44, 79664 Wehr, Baden-Wurttemberg, Germany is approved by Australian TGA.
189
Keeping in view earlier decision for such cases, the Board approved request of the
firm. However, firm will submit legalized CoPP from Australian TGA of Galvus Met
50/500mg Tablets, manufactured by M/s. Novartis Pharma Produktions GmbH, Oflinger
Str. 44, 79664 Wehr, Baden-Wurttemberg, Germany and authorized its Chairman for
issuance of letter.
Case No. 08. Registration of more than one formulation for a manufacturer.
Patron in Chief of Pakistan Veterinary Pharmaceuticals Association, Rawalpindi have

forwarded copies of registration letters granted to M/s. Attabak Pharmaceuticals, Islamabad and
informed that he received complaints from various Veterinary Manufacturers regarding one
Special Manufacturer i.e. M/s. Attabak Pharmaceuticals, Islamabad, which after details
investigation forwarded to the DRAP.
According to Drug Act, 1976, the manufacturer has undertaken that they dont have any
registration in same formulation before. Is the manufacturer is kidding with DRAP, or he is using
his political influence.
Patron in Chief of Pakistan Veterinary Pharmaceuticals Association, Rawalpindi has

further requested to de-register all the same formulations which were granted to M/s. Attabak
Pharmaceuticals, Islamabad.
List of duplicate registered drugs of different brand names registered of same composition.
S.No. Regn. Brand Name Composition Manufacturer Pack

No. Size
1. 063713 LINSPEC EACH ML CONTAINS:- ATTABAK 50ML.

INJECTION. LINCOMYCIN PHARMACEUTICALS 100ML.
HYDROCHLORIDE ISLAMABAD 500ML
USP50MG.
SPECTINOMYCIN
DIHYDROCHLORIDE
PENTAHYDRATE
USP100MG.
190
2. 075701 LINCOPECT EACH ML CONTAINS:- M/S. ATTABAK 10ML
INJECTION LINCOMYCIN AS PHARMACEUTICALS, 20ML
HCL.50MG PLOT # 5C, I-10/3, 50ML
SPECTINOMYCIN AS INDUSTRIAL AREA, 100ML
HCL100MG ISLAMABAD.
3. 075711 LINCOMAT EACH ML CONTAINS:- M/S. ATTABAK 10ML
INJECTION LINCOMYCIN AS PHARMACEUTICALS, 20ML
HCI...50MG PLOT # 5C, I-10/3, 50ML
SPECTINOMYCIN INDUSTRIAL AREA, 100ML
..100MG ISLAMABAD.
4. 034541 ENROBAK-10 EACH 100ML ATTABAK 100ML.
ORAL CONTAINS:- PHARMACEUTICAL 500ML.
SOLUTION. ENROFLOXACIN..10GM INDUSTRIES, 1LIT.
. ISLAMABAD.
5. 075708 ENROMAT EACH 100 ML M/S. ATTABAK 100ML
ORAL LIQUID CONTAINS:- PHARMACEUTICALS, 150ML
ENROFLOXACIN ..10G PLOT # 5C, I-10/3, 250ML
INDUSTRIAL AREA, 500ML
ISLAMABAD. 1 LITER
6. 048160 RESPITIL EACH ML CONTAINS:- ATTABAK 100ML
AQUEOUS TILMICOSIN (AS PHARMACEUTICALS, 250ML
CONCENTRATE PHOSPHATE)250MG ISLAMABAD. 500ML
. (MACROLIDE CLASS 1000ML
ANTIBIOTICS).
7. 075706 TILMICOBAK EACH 100ML M/S. ATTABAK 100ML
ORAL LIQUID CONTAINS:- PHARMACEUTICALS, 150ML
TILMICOSIN PLOT # 5C, I-10/3, 250ML
PHOSPHATE.........25G INDUSTRIAL AREA, 450ML
ISLAMABAD. 500ML
1 LITER
5 LITER
8. 049786 BROMBAK EACH ML CONTAINS: - ATTABAK PHARMA 100ML
SOLUTION BROMHEXINE HCL ISLAMABAD 250 ML
50MG 300 ML
500 ML
9. 075705 BROM-MAT EACH ML CONTAINS:- M/S. ATTABAK 100ML

ORAL LIQUID BROMHEXINE PHARMACEUTICALS, 150ML
HCI...50MG PLOT # 5C, I-10/3, 250ML
ISLAMABAD. 1 LITER
5 LITER
191
10. 048169 GENTYLOBAK EACH ML CONTAINS:- ATTABAK 50ML
INJECTION. GENTAMYCIN (AS PHARMACEUTICALS, 100ML
SULPHATE)B.P50MG ISLAMABAD.
TYLOSIN (AS
TATRATE)B.P100MG
(ANTIBIOTICS).
11. 075709 GENTYMAT EACH ML CONTAINS:- M/S. ATTABAK 50ML

LIQUID TYLOSIN PHARMACEUTICALS, 100ML
INJECTION TARTRATE...100M PLOT # 5C, I-10/3,
G INDUSTRIAL AREA,
GENTAMYCIN ISLAMABAD.
SULPHATE.50MG
12. 049693 SULPHAGOLD EACH ML CONTAINS:- ATTABAK 50ML.
INJECTION. SULPHADIMIDINE PHARMACEUTICALS, 100ML.
SODIUM (B.P. VET) ISLAMABAD. 500ML.
333.33MG.
13. 075688 SULPHA SUPER EACH ML CONTAINS:- M/S. ATTABAK 10ML
INJECTION SULFADIMIDINE PHARMACEUTICALS, 50ML
SODIUM33.30% PLOT # 5C, I-10/3, 100ML
ISLAMABAD.
14. 058892 GENTABAK 5% EACH ML CONTAINS: - ATTABAK 50ML
LIQUID GENTAMYCIN PHARMACEUTICAL 100ML
INJECTION SULPHATE ISLAMABAD
(BP)50MG/ML
(ANTIBIOTIC)
15. 075699 GENTA-5 EACH 100ML M/S. ATTABAK 10ML
SUPER CONTAINS:- PHARMACEUTICALS, 20ML
INJECTION GENTAMYCIN PLOT # 5C, I-10/3, 50ML
SULPHATE .5G INDUSTRIAL AREA, 100ML
ISLAMABAD.
16. 034550 GENTABAK-10 EACH ML CONTAINS:- ATTABAK 30ML.
INJECTABLE. GENTAMYCIN PHARMACEUTICAL 50ML.
(SULPHATE) BASE INDUSTRIES, 100ML.
EQ 100MG. ISLAMABAD.
17. 075700 GENTA-10 EACH 100ML M/S. ATTABAK 10ML

SUPER CONTAINS:- PHARMACEUTICALS, 20ML
INJECTION GENTAMYCIN PLOT # 5C, I-10/3, 50ML
SULPHATE.10G INDUSTRIAL AREA, 100ML
ISLAMABAD.
18. 058878 PULMOTIN EACH 1000G ATTABAK 100GM
WATER CONTAINS: - PHARMACEUTICAL 250GM
SOLUBLE TYLOSIN ISLAMABAD 300GM
POWDER TARTARATE.100GM 500GM
DOXYCYCLINE 1000GM
HYDROCHLORIDE
(USP).200GM
COLISTIN
192
SULPHATE480MIU
BROMOHEXINE
HYDROCHLORIDE.5GM
(ANTI BACTERIAL,
MUCOLYTIC)
19. 075690 PULMOBRO EACH 1000G M/S. ATTABAK 100G
WATER CONTAINS:- PHARMACEUTICALS, 250G
SOLUBLE DOXYCYCLINE PLOT # 5C, I-10/3, 500G
POWDER HCL...200G INDUSTRIAL AREA, 1 KG
TYLOSIN ISLAMABAD. 5 KG
TARTRATE.100G 10 KG
COLISTINE
SULPHATE480MIU
BROMHEXINE
HCL....5G
20. 049712 CRD-RAZE EACH 1000GM ATTABAK 100GM.
WATER CONTAINS:- PHARMACEUTICALS, 250GM.
SOLUBLE TYLOSINE TARTRATE ISLAMABAD. 500GM.
POWDER. (BP) ..100GM. 1000GM
DOXYCYCLINE .
HYDROCHLORIDE
(BP) 200GM.
COLISTIN SULPHATE
(BP) ..500 MIU.
BROMOHEXINE HCL
(BP) 5GM.
21. 071059 PULMO-FORTE EACH 1000GM ATTABAK 100G
WATER POWDER CONTAINS:- PHARMACEUTICAL 250G
SOLUBLE DOXYCYCLINE ISLAMABAD. 500GM
POWDER HCL .200G 1 KG
TYLOSIN 5 KG
TARTRATE 100G 10 KG
COLISTIN 25 KG
SULPHATE 500MIU
BROMHEXINE
HCL .. 5G
22. 049785 ECA MIX EACH 100GM ATTABAK PHARMA 100GM
WATER CONTAINS: - ISLAMABAD 250GM
SOLUBLE ENROFLOXACIN.10% 500GM
POWDER COLISTIN 1000GM
SULPHATE.. 3.5%
AMANTADINE4
%
23. 075683 E.N.C. MAN EACH 100G M/S. ATTABAK 100G
WATER CONTAINS:- PHARMACEUTICALS, 250G
SOLUBLE ENROFLOXACIN PLOT # 5C, I-10/3, 500G
POWDER HCI.10G INDUSTRIAL AREA, 1 KG
COLISTIN ISLAMABAD. 5 KG
SULPHATE.3.5G 10 KG
AMANTADINE
193
HCI.4G
24. 049719 COLIFLOX EACH ML CONTAINS:- BIOGEN PHARMA, 50ML.

ORAL LIQUID. ENROFLOXACIN.100M RAWAT. 100ML.
G 150ML.
COLISTIN 200ML.
SULPHATE ... 250ML.
48MIU. 450ML.
500ML.
1 IT.
5 LIT.
25. 075618 ENROMAX EACH ML CONTAINS:- M/S. BIOGEN 50ML
LIQUID ENROFLOXACIN.100M PHARMA. 100ML
G 8TH KM RAWAT CHAK 150ML
COLISTIN BELI ROAD, 200ML
SULPHATE...........48 RAWAT. 250ML
MIU 450ML
500ML
1 LITRE
5 LITRE
26. 052306 PHAZ-ENRO- EACH 100ML CHERISHED 20ML
COLIS LIQUID CONTAINS: - PHARMACEUTICAL 50ML
ENROFLOXACIN.10GM (PVT) LTD., LAHORE 100ML
COLISTIN
SULPHATE.50,000,000
IU
27. 052376 PHAZ-ENRO- EACH 100ML CHERISHED 20ML
COLIS LIQUID CONTAINS: - PHARMACEUTICAL 50ML
ENROFLOXACIN10G (PVT) LTD., LAHORE 100ML
M
COLISTIN
SULPHATE.50,000,000
IU
28. 053943 ENROMONT 10 EACH 100ML WESTMONT 100ML
ORAL CONTAINS: - PHARMACEUTICALS 250ML
SOLUTION ENROFLOXACIN.10G INDUSTRY 500ML
M RAWALPINDI. 1 LITER
29. 058936 ANROX PLUS EACH ML CONTAINS:- WESTMONT 100ML

10% ORAL ENROFLOXACIN...10G PHARMACEUTICAL 250ML
LIQUID M INDUSTRY 500ML
(ANTIBIOTIC/EXPECTO RAWALPINDI 1000ML
RANT).
194
The case was placed before the Registration Board and it was decided to call the firm
M/s. Attabak Pharmaceuticals, Islamabad for personal hearing.
Decision: Dr.Israr Shah, Chief Executive of M/s Attabak Pharmaceuticals, Islamabad

appeared before the Board and argued that these formulations are not identical but have
different compositions. Registration Board constituted following committee to scrutinize all
such cases and forward its recommendations for consideration of the Board.
Prof.Dr.Muzamil H Najmi, Member registration Board

Dr.Noor Muhammad Shah, Director MD&MC
Mr.A.Q.Javed Iqbal, Director QA & LT
Dr.Tariq Siddique, DDG (RII) Convenier
The committee can co-opt any expert for assistance.
Case No. 09. Change of Manufacturing Site.
M/s. Pfizer Pakistan Limited, Karachi have requested to approve the change of
manufacturing site of their following registered imported drugs from M/s. Pfizer Ireland
Pharmaceuticals, Loughbeg, Country Cork, Ireland to M/s. Pfizer Pharmaceuticals LLC,
Km. 1.9, Road 689 Vega Baja, PR 00693, Puerto Rico, USA:-
S. No. Reg. No. Name of Product (s).
1. 023620 Lipitor Tablets 10mg.

(Atorvastatin)
(Atorvastatin)
(Atorvastatin)
M/s. Pfizer Pakistan Limited, Karachi have further submitted that package and release
site will remain the same i.e. M/s. Pfizer Manufacturing Deutschland GmbH, Betriebsstatte
Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.
The firm have deposited required fee Rs.100000x3=300,000/- and submitted following
supporting documents:-
195
i) GMP Certificate - M/s. Pfizer Pharmaceuticals LLC, Km. 1.9, Road 689 Vega
Baja, PR 00693, Puerto Rico, USA.
ii) Original Legalized Certificate of Pharmaceutical Products.
iii) Copy of registration letter.
iv) Copy of substitution of name of the company from M/s. Parke-Davis & Company
Limited, Karachi to M/s. Pfizer Pakistan Limited, Karachi.
v) Copy of change of manufacturing site of Lipitor Tablets.
vi) Copy of NOC for CRF.
vii) Site Master File.
Registration of drugs is valid as substitution of name of the company from M/s. Parke-
Davis& Company Limited, Karachi to M/s. Pfizer Pakistan Limited; Karachi was approved on
29th June, 2011.
M/s. Pfizer Pakistan Limited, Karachi was advised to clarify that the name of the
product on CoPP issued by Germany is Sortis while in Pakistan is Lipitor andalso
advised to deposit the balance fee as per revised fee Schedule F and approval of the
regulatory authorities in US FDA, EMA, TGA and Japan or WHO prequalification.
In response, M/s. Pfizer Pakistan Limited, Karachi have submitted that package and
release site will remain unchanged i.e. M/s. Pfizer Manufacturing Deutschland GmbH,
Betriebsstatte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany, therefore, they would like
to clarify and elaborate further that the CoPP is issued by Germany and the product is available
by the trade name of Sortis in Germany while the same is available with the trade name of
Lipitor in Pakistan. For that matter, the declaration letter has already been submitted
previously along with the original CoPP. US letter of approval of Lipitor attached for kind
perusal.
M/s. Pfizer Pakistan Limited, Karachi was also advised to submit CoPP of US-FDA for
the present site located at Puerto Rico. In response, M/s. Pfizer Pakistan Limited, Karachi have
submitted CoPP of the product Lipitor US-FDA of M/s. Pfizer Pharmaceuticals LLC, Vega
Baja, PR, USA.
M/s. Pfizer Pakistan Limited, Karachi was again advised to clarify that as you want inclusion of
M/s. Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany as packaging & release site.
The GMP certificate issued by German authorities indicates that the firm M/s. Pfizer
196
Manufacturing Deutschland GmbH, Freiburg, Germany is only authorized for quality control
testing and batch certification and not for packaging of imported products. Although the firm has
the tablet facilities but it is for high-potent or potentially hazardous materials.
In response, M/s. Pfizer Pakistan Limited, Karachi have requested to refer to the section
3.2.P.3.1 of the submitted dossier. Further to elaborate M/s. Pfizer Manufacturing Deutschland
GmbH, Betriebsstatte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany is allowed for the
secondary packaging of all the dosage forms which has undergone primary packaging. There is
no restriction of packaging to any special dosage form. They have listed down the sites involved
in Lipitor 10mg, 20mg & 40mg tablets starting from manufacturing till release:-
Process Site Name
Bulk product manufacturing M/s. Pfizer Pharmaceuticals LLC,
Km. 1.9, Road 689 Vega Baja, 00693,
Puerto Rico, USA.
Primary Packaging M/s. Pfizer Manufacturing Deutschland
GmbH, Betriebsstatte Freiburg,
Mooswaldallee 1, 79090 Freiburg,
Germany.
Secondary Packaging M/s. Pfizer Manufacturing Deutschland
Germany
Quality Control Testing Both sides are involved (Freiburg,
Germany and/ or Vega Baja, PR).
Batch Release M/s. Pfizer Manufacturing Deutschland
Germany.
M/s. Pfizer Pakistan Limited, Karachi have further submitted that it is imperative to
elucidate the fact that the given above site is already approved for packaging and release of
Lipitor 10mg, 20mg & 40mg Tablets by Drug Regulatory Authority of Pakistan and also and is
working under the Manufacturing License issued by Regional Administration Authority, State of
Baden Wuerttemberg, Germany. Copy of Manufacturing License enclosed for kind study.
Further to inform that the same site is also performing manufacturing/packaging activities of
Lipitor tablets for a number of countries worldwide including US, UK and Canada.
The firm has not submitted Form-5 (A), and site master file of the new source. The case
was filed before the approval of the SOPs for the post marketing changes. The documents
197
submitted by the firm are a email record by the firms management and not legalized as per
approved procedure. The legalized documents i.e. GMP certificate did not support the firms
claim i.e. primary packaging of Atorvastatin is allowed in the same facility.
Firm is called for personal hearing on her request.
Decision: Dr. Farid Khan along with his team appeared and provided copy of CoPP
issued by German Regulatory authorities for the Lipitor Tablet indicating their approval
for primary packaging in the same facility. The Board approved request of the firm and
advised firm to submit original legalized CoPP and authorized its Chairman for issuance of
letter.
Case No. 10. Voltral 12.5 Suppositories Novartis Pharma.

Drug Registration Board in its various meetings approved the registration of following
drugs in the name of M/s. Novartis Pharma (Pakistan) Limited, Karachi subject to inspection of
manufacturer abroad, verification of storage facilities and price fixation / calculation etc as per
policy:-
S. # Name of Name of Drug (s)/ DMRP/ Meeting.

Manufacturer. Composition. Pack Size
1. M/s. Delpharm Huningue Voltral 12.5 Rs.187.50/Per 10 238th meeting held
S.A.S, 26, rue de la Suppositories Suppository on 05-06th August,
Chapelle, Huningue, France.Each suppository Rs.18.75/Per 2013.
contains:- Suppository
Diclofenac sodium
12.5mg.
2. M/s. Novartis Pharma Voltral 50mg Rs.380/10s -do-

S.A.S, Huningue, France. Suppositories
Each suppository
contains: -
Diclofenac sodium 50mg.
The firm was advised to provide CoPP from country of origin i.e. France but the firm
M/s. Novartis informed that above mentioned drugs are not registered for free sale in its country
of origin i.e France. The Board discussed matter of non-availability of finished drug in country
of origin in its 242nd meeting. It was deliberated that finished drug should be permitted for
198
import only if it is for free sale in country of origin. Thus the Board decided to call firms
representatives for presentation of their case in next meeting.
Decision: Dr. Ahson Siddiqi along with his team appeared before the Board and
informed that the product is not on free sale in country of origin due to commercial reasons
but the product manufactured from the same facility i.e. M/s. Delpharm Huningue S.A.S,
26, rue de la Chapelle, Huningue, France is approved by TGA Australia which is a
reference agency for registration in Pakistan.
Keeping in view earlier decision for such cases, the Board approved request of the firm.
However, firm will submit legalized CoPP of Voltral 12.5mg Suppositories and Voltral
50mg Suppositories, manufactured by M/s. Delpharm Huningue S.A.S, 26, rue de la
Chapelle, Huningue, France and authorized its Chairman for issuance of letter.
Registration-II
Case No.11. Grant of Registration for Export Purpose - Contract Manufacturing
Following firms have requested for registration of drug for export purpose only, on
basis of contract manufacturing.
Contract giver Contract Name of Drug(s) & Composition Date of application,

manufacturer Diary No. & Form
M/s Genix Pharma, M/s Surge Labs, X-TER IV Injection 250mg 15-05-2014
Karachi Sheikhupura Each vial contains:- 695
Ceftriaxone Sodium USP eq. to Form-5
Ceftriaxone .250mg Rs.20,000/-
+ Water for Injection 5ml
-do- -do- X-TER IV Injection 500mg 15-05-2014
Each vial contains:- 694
Ceftriaxone .500mg Rs.20,000/-
-do- -do- X-TER IV Injection 1gm 15-05-2014
Each vial contains:- 693
Ceftriaxone .1gm Rs.20,000/-
-do- M/s Nabiqasim Xime Dry Suspension 100mg/5ml 15-05-2014
Industries, Karachi Each 5ml contains:- 691
Cefixime USP .100mg Form-5
Rs.20,000/-
-do- -do- Xime Dry Suspension 200mg/5ml 15-05-2014
199
Each 5ml contains:- 692
Rs.20,000/-
-do- -do- Xime Capsule 400mg 15-05-2014

Each capsule contains:- 692
Rs.20,000/-
M/s Martin Dow Ltd, M/s Seatle (Pvt.) Martin Dow Cefpodoxime 26-05-2014
Karachi Ltd, Lahore Suspension 696
Each 5ml contains:- Form-5
Cefpodoxime as Proxetil .40mg Rs.20,000/-
Decision: Registration Board granted registrations of above products on contract

manufacturing basis for export purpose only.
Case No.12 Extension in permission for Bulk import of Arthrotec 50mg Tablets (Reg.
No.023362) of M/s Pfizer Labs, Karachi
Registration Board in 242nd meeting permitted M/s Pfizer Labs, Karachi for import of
Arthrotec 50mg Tablets from M/s NPIL Pharma Ltd, U.K in blister form and then further secondary
repacking and final quality control release in M/s Pfizer Labs, Karachi. Permission was for 05 years time.
The firm provided legalized COPP of the product for further processing of case. But it was noted that
mnufacturer of Arthrotec 50mg Tablets is M/s Primal Healthcare UK Limited, Whalton Road, Morpeth,
Northumberland, NE61 3YA, United Kingdom instead of M/s NPIL Pharma Ltd, U.K. Chairman,
Registration Board corrected the minutes and submitted for consideration of Registration Board.
Decision: Registration Board ratified the correction in name and address of manufacturing
site for Arthrotec 50mg Tablets, Reg. No.023362.
Case No.13 Personal hearing cases:
a. M/s PharmEvo (Pvt.) Ltd, Karachi
M/s PharmEvo (Pvt.) Ltd, Karachi has informed that they have been granted registration of Xcept
10mg Tablet, Reg. No.076157 by the Registration Board in 239th meeting but due to typographical error
of applied price they have submitted subsequent corrected price. Firm has submitted that they were
granted registration letter with MRP below than Price Advisory Committee approved price, so they
cannot be rational for their commercial activity. Details are as under:-
S. Existing Name, Composition, pack Reg. No. Requested Name, Composition, pack
200
No. size & MRP size & MRP
I II III IV
(i) Xcept 10mg Tablet 076157 Xcept 10mg Tablet
Each tablet contains:- Each tablet contains:-
Rivaroxaban 10mg Rivaroxaban 10mg
(Manufacturers Specification) (Manufacturers Specification)
Pack Size : 10s Pack Size : 10s

MRP : Rs.1714.00 MRP : Rs. 5023.00
Pack Size : 30s Pack Size : 30s

MRP : Rs.5142.00 MRP : Rs.13864.00
Firm has requested that they may be granted MRP as fixed by the DAC. Case was deferred by
for personal hearing / presentation by the firm in Registration Board meeting.
Decision: Dr.Mazhur ul Islam Director Technical PhatmEvo along with his team
appeared before the Board and submitted that initially firm applied for registration of
Xcept 10mg Tablet with less MRP (as mentioned in column II) but submitted revised MRP before
consideration of registration application by Registration Board and fixation of MRP by Drug
Pricing Committee. Firm also presented photocopy of documents for revised request submitted in
DRAP.
Registration Board discussed the case and decided to get opinion from Cost & Price
Division whether MRP submitted with registration application can be revised by the applicant
before consideration of registration application by the Board or otherwise. Opinion of this Division
will be considered by Regiostration Board.
b. Notification of intent to withdraw license for oral formulations of Nizoral

(Ketoconazole) tablets (Regn. No.006799).
M/s Johnson & Johnson Pakistan (Pvt.) Ltd, Karachi has informed that to delist and will
stop the manufacturing and distribution of Nizoral (Ketoconazole) Tablets, Reg. No. 00679, once
product has expired from the market. The decision does not impact other topical formulations i.e
Nizoral Cream, which will continue to be made available.
Nizoral (Ketoconazole) Tablets, Reg. No. 006799 has a positive benefit - risk profile for
the restricted indications when used appropriately with a risk mitigation strategy in place, as no
201
new safety signals have been identified. However, based on feedback received from health
authorities, there are very limited interests in the indications that the company is proposing.
Registration Board in its 240th meeting had deferred request of firm for confirmation of
international regulatory status including USFDA, EMA, Japan and Australia. Accordingly, M/s
Johnson & Johnson Pakistan (Pvt.) Ltd, Karachi has submitted that regulatory status in USFDA, EMA,
Australia TGA & Regulatory body of Japan.
Regulatory status in the EU is that the Marketing Authorization of Nizoral Tablets have been
withdrawn, with the below status for Spain and France.
In Spain the MA is Withdrawal of MA submitted to HA on 16 October 2013. HA has posponed the

withdrawal authorisation until the current stock in warehouse is exhaused. The HA has postponed the
authorisation of the withdrawal until the current stock has been exhaused in Spain and this stock will be
used under compassionate use authorised by HA for hospitals only. The HA have requested the compnay
to submit the temporal Marketing suspension of the product. This was submitted on 06 th November, 2013
and temporally suspended as of 07th November, 2013. Once the current stock has been exhaused the HA
will approve the withdrawal.
France the status issuspended since July, 2011 and MA withdrawal has been submitted to HA 18 th
December, 2013, pending approval.
Australia: the MA of Nizoral Tablets is withdrawan
US No Janssen product in market since 2006. Notification of intent to delist submitted to FDA 01st
May, 2008. NDA withdrawal process is ongoing. Generic Ketoconazol tablets remain in the US market.
Japan Nizoral Tablets has never ben marketed by Janseen in Japan.
Registration Board in 241st meeting decided to call firm for personal hearing.
Decision: Dr. Laila Mughal Director Regulatory Affiars along with her team appeared
before the Board and submitted that oral Ketoconazol is hepatotoxic and thus company has
decided to with draw Nizoral tablets, Regn. No.006799 from market and requeste d for de-
registration of product.
202
Registratio Board discussed the case in light of risk- benefit ratio of oral
ketoconazole and availability of alternate therapy acceded request of M/s Johnson &
Johnson Pakistan for de-registration of Nizoral tablets, Regn. No.006799. Moreover, the
Board also decided to issue show cause notices to other registered oral ketoconazole
products for de-registration of product due to safety concerns.
C: Change of bulk import source Telfast D Tablets M/s Sanofi Aventis Pakistan Ltd,
Karachi
Registration Board in 239th meeting permitted M/s Sanofi Aventis, Karachi for import of
Telfast-D tablet from M/s Sanofi Aventis, Kansas, USA in tablet form and then further
processing to finished form in M/s Sanofi-Aventis, Karachi for 02 years time. However, the
Board advised firm to provide legalized COPP of the source and authorized its chairman to
accord approval for issuance of regsirtation letter. The Board further advised the firm to apprise
them about future strategy for transfer of technology to Pakistan in 02 months time.
During meeting Mr.Muhammad Idress incharge QA and Mr.Jaffar Zaidi, Regulatory
Officer, SITE appeared before the Board and presented that they have tried to make
arrangements for local manufacturing of the product but their principal did not agree to the
proposal as M/s Sanofi Aventis, Arkansas, USA is the only site of M/s Sanofi Aventis for
providing Telfast-D tablets across the globe.
Now M/s Sanofi Aventis Pakistan Ltd, Karachi has requested for change of bulk import source
for their already registered drug Telfast - D Tablet, Reg. No. 023617. Existing and proposed bulk import
sources are as under:-
Existing Bulk import source Proposed Bulk import source
M/s Sanofi Aventis U.S LLC, 10236 Marion Parke Sanofi Winthrop Industries, 56 route de choisy-au-
Drive, Missouri, Kansas City 64134-0708, USA Bac Compiegne 60205, France
Firm has submitted following documents to support their request.
i) Form-5
ii) Copy of registration letters along with renewal status
iii) Original legalized Certificate of Pharmaceutical Product from Australian TGA.
iv) Original leglalizd GMP Certificate
v) Fee Rs.100,000/- for the purpose
203
Scrutiny of documents revealed that COPP of the product is from Australin TGA and firm
confirmed that product of new site is not available in country of manufacture i.e. France.
Registration Board discussed in detail matter of non-availability of drug of the manufacturer in

France and decided to call firm,s representatives for presentation of their case.
Decision: Dr. Shuja ud Din Shaikh Director Regulatory Affairs along with his team
appeared and informed that Sanofi Winthrop Industries, 56 route de choisy-au-Bac Compiegne
60205, France is new manufacturing site for Telfast D Tablets but the product is not on free
sale in country of origin but the product manufactured from same manufacturing site is
approved by Australian TGA and firm has provided legalized CoPP as well.
Keeping in view earlier decision for such cases, the Board approved new
manufacturing site for Telfast D tablets, Registration no. 023617 as Sanofi Winthrop
Industries, 56 route de choisy-au-Bac Compiegne 60205, France.
Case No.14 Registration of Drugs for export purpose-Not me too Drugs.

a. M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi:
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has informed that they have granted
registration of following drugs for export purpose which are not me too but registered for export
purpose only with different brand name. Now they intend to export these formulations to
Combodia & Afghanistan with different brand name. Details are as under:-
S. Existing brand name for Proposed Brand name and

No. export purpose & Reg. No. formulation
1. Fludol DM Syrup Reltus DM Syrup
Each 5ml contains:- Each 5ml contains:-
Dextromethorphan HBr 10mg Dextromethorphan HBr 10mg
Phenylephrine HCl BP.5mg Phenylephrine HCl BP..5mg
Chlorpheniramine Maleate 2mg Chlorpheniramine Maleate. 2mg
Reg. No.004019-EX
2. Fludol P + Syrup Reltus C&F Syrup

Each 5ml contains:- Each 5ml contains:-
Paracetamol120mg Paracetamol ..120mg
Phenylephrine HCl 5mg Phenylephrine HCl BP..5mg
Chlorpheniramine Maleate 1mg Chlorpheniramine Maleate. 1mg
204
Reg. No.004099-EX
The Registration Board in its 243rd meeting held on 8th& 9th May, 2014 had considered above
mentioned case and decided to advise the firm to provide original import order.Now the firm has
furnished the original import orders from Combodia and Afghanistan.
Decision: Keeping in view import order, Registration Board approved above

formulations for registration for export purpose only.
b. M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi:
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi have requested for registration of
following drugs for export purpose only which are not me-too. Details are as under:-
S. Name of Name of product(s) Date of application,

No. Company Diary No. & Form
1. M/s Ferromate 322mg Tablet 07-05-2014
Pharmatec Each tablet contains:- 681
Pakistan, Ferrous Fumarate 322mg Form-5
Karachi Rs.20,000/-
2. -do- Ferromate Suspension 07-05-2014

Each 5ml contains:- 680
Ferrous Fumarate 140mg Form-5
Rs.20,000/-
Firm has furnished following documents to support their request:-
a. NOC for CRF clearance.

b. Copy of approved section from CLB.
c. Copy of last inspection report.
d. An undertaking that applied registration is exclusively for export purpose and will not
be sold in Pakistan.
e. Original import order from importing country i.e U.K
Decision: Keeping in view import order, Registration Board approved above

formulations for registration for export purpose only.
205
c. M/s Ophth Phama (Pvt.) Ltd, Karachi:
M/s Ophth Pharma (Pvt.) Ltd, Karachi have requested for registration of
following drugs for export purpose only which are not me-too. Details are as under:-
S. Name of Name of product(s) Date of application,

No. Company Diary No. & Form
1. M/s Limus Eye Ointment 27-11-2013
Ophth Each gram contains:- 599
Pharma, Tacrolimus .1.0mg Form-5
Karachi Rs.20,000/-
Firm has furnished following documents to support their request:-
a. NOC for CRF clearance.

b. Copy of last inspection report.
c. An undertaking that applied registration is exclusively for export purpose and will not be
sold in Pakistan.
Original import order from importing country i.e Afghanistan
Decision: Registration Board was informed that applied formulation is in eye drops
and it is mentioned as eye ointment mistakenly and same is mentioned in import order.
Thus Registration Board approved 0.2% formulation (Tacrolimus) in eye drops for
registration for export purpose only.
Registration IV
Case No.15 Correction in decision of 243rd meeting Registration Board.
Registration Board in its 243rd meeting held on 8-9/5/2014 approved the following drugs
in favor of new Drug Manufacturing License.
Wimits 1.Metrofena As per 1. Form 5 1. Approved
Pharmaceuticals 2. suspension SRO/ 2.Dependal-M
Plot # 129 Oral Suspension 60ml 2.Normal (GSK)
Sundar 3. Each 5ml Contains: 3. 1365 .23- 3.Firm is new
Industrial Furazolidone BP..25mg 12-2013 licence as per
Estate, Raiwind Metronidazole as 4. penal inspection
Road Lhr Benzoate .. 75mg Rs.20,000/- dated
Pakistan. 4. Anti-Amoebic 26.11.2013
5. Manufacturers Specs
206
M/s Wisdom Moradil Suspension 60ml/A 1. Form5 2. Dependal-M Approved
harmaceuticals Each 5ml contains:- s 2. 10-9-2013 (Glaxosmithklin with change
Industry, Metronidazole Benzoate perSRO Dy.No.2905 e) of name
78-A, Industrial eq. to Metronidazole 3. 10-9-2013 [Metronidazole:
Estate (B.P)40mg (Rs.20000/-) 75mg/5ml,Fura
Hayatabad, Furazolidone zolidone:25mg/
Peshawar. (B.P)..25mg 5ml] susp
(Capsule (Amoebicide)
Cephalosporin (Manufacturers) 3.Grant of DML
Section) recommended
No. F.3-5/2004- (25-04-13)
Lic(M-232)
dated 12-09-13
The above mentioned formulation is already deferred and referred to review committee.
Decision: As above formulations are under review by review committee thus the Board
deferred above formuations till recommendations of review committee and decision of the
Board.
Registration V
Case No. 16. Violation of SRO 1103 (I) 2006 by M/s Sarco Chemical Industries, Multan
Personal hearing there of.
Case of M/s Sarco Chemical Industries, Multan was discussed in 243 rd meeting of
Registration Board with reference to the notice of honorable Supreme Court of Pakistan in the
human rights case no. 4740/2013 and subsequent decision of drug pricing committee regarding
de-registration of Y-Zee Injection 1 g (Ceftriaxone Sodium USP) manufactured my M/s Florence
Pharmaceutics, Islamabad for M/s Sarco Chemical Industries, Multan. The instant case was
related to violation of SRO 1103 (I) 2006 which was discussed in the 7thmeeting of drug pricing
committee held on 21-08-2013wherein case was referred to the Pharmaceutical Evaluation &
Registration Division for de-registration of the drug for violating Section 5 of aforementioned
SRO, which is reproduced as under:
De-registration of the Drug: The Drug, the price of which is not fixed in accordance
with these rules shall de-registered after giving an opportunity of being heard to the
concerned company or firm, as the case may be.
207
After through deliberations the Registration Board in 243 rd meeting decided to provide
the opportunity of personal hearing to both M/s. Sarco Chemical Industries, Multan & M/s.
Florence Pharmaceuticals, Islamabad in next meeting. Accordingly both the firms have been
called for personal hearing.
Decision: Representatives of both firms appeared before the Board and presented their
view point. After having heard both parties, the Board decided to direct DDG (E&M),
Islamabad and Area FID Islamabad to investigate the matter and submit a comprehensive
report in a month for further necessary action.
Item No.VII Biological Drugs
Case No. 01 Applications for the registration of local manufactured biological drugs.
The following cases were discussed in the 243rd Meeting of Registration Board. The minutes were
recorded as under: -
i. M/s Getz, Karachi: the panel observed in detail their entire GMP system during 2
days of inspection, respective dossier of under registered products are already been
evaluated for clinical and non-clinical aspects by the ECBD and Board itself. The
panel inspected their facility and documents to ascertain their manufacturing and
testing capabilities for biotech products and overall GMP compliance level. Based on
the above observations and contents of the attached report the Panel is of the opinion
that their GMP system supports to manufacture all their under reference biotech
products locally including Unipeg injection in vials and PFS 20kDa and 40kDa
which is locally pegylated and manufacturing of PEG-Interferon alfa 2a.
ii. The recommendation of PSI committee for Unipeg also discussed and the board
approved as criteria as indicated in clause (i) above.
The Registration Board Decisions are shown in column 6:
Applicant Product Recommendation Decision of Decision of Decision of

Specifications s of the PSI Panel DRB the Board in the Board in
Subcommittee its 242nd its 243rd
Meeting. Meeting.
208
1. Getz Eptifib Solution Recommended Recommende Product Decision
Pharma, for Infusion Pack size d Approved, recorded in
Karachi 75mg/100ml 100ml in vial in however, 242nd
API in Each ml contains: unit carton. cGMP / Meeting
LDPE bags Eptifibatide.0.7 COPP is upheld.
further 5 mg required of Further, all
packed in (Anti-thrombotic the finished firms will
Al.foil agent) Drug submit Bio-
packs (Drug (Local manufacture comparabilit
substance) manufacture) d using this y data
(in particular followed by
lyophilized drug regular
powder substance in Pharmaco-
form) will the country vigilance
be imported of origin. report.
from M/s Biosimilarity
Hybio data of
Pharmaceuti locally
cal Co. Ltd, manufacture
No.37, Keji d drug needs
C. Str. 2nd, to be
Shenzhen disclosed by
Hi-Tech the local
Industrial manufacturer
Park China .
for local
formulation.
209
2. Getz Eptifib Solution for Recommended Recommended Product Decision recorded
Pharma, Injection 20mg/10ml Pack size Approved, in 242nd Meeting
Karachi Each ml contains: 10ml in vial in however, upheld. Further, all
API in Eptifibatide.2mg/ml unit carton.
cGMP / COPP firms will submit
LDPE bags (Anti-thrombotic
further agent) is required of Bio-comparability
packed in (Local manufacture) the finished data followed by
Al.foil Drug regular Pharmaco-
packs (Drug manufactured vigilance report.
substance) using this
(in particular drug
lyophilized
substance in
powder
form) will the country of
be imported origin.
from M/s Biosimilarity
Hybio data of locally
Pharmaceuti manufactured
cal Co. Ltd, drug needs to
No.37, Keji
be disclosed by
C. Str. 2nd,
Shenzhen the local
Hi-Tech manufacturer.
Industrial
Park China
for local
formulation.
210
3. Getz EnoxaInjection Recommended Recommended Product Decision recorded
Pharma, 20mg/0.2ml Injection Pack Size approved, in 242nd Meeting
Karachi Each Pre-filled 2-Prefilled however, upheld. Further, all
API in syringe contains:- syringes in unit
cGMP / COPP firms will submit
LDPE bags Enoxaparin carton.
further sodium..20 is required of Bio-comparability
packed in mg/0.2ml USP the finished data followed by
Al.foil (Antithrombotic Drug regular Pharmaco-
packs (Drug agent) manufactured vigilance report.
substance) (Local manufacture) using this
(in powder particular drug
form) will
substance in
be imported
from M/s the country of
Hebei origin.
Changshan Biosimilarity
Biochemical data of locally
cal Co.,
drug needs to
Ltd.,
Shijiazhuan be disclosed by
g China for the local
local manufacturer.
formulation.
4. Getz Enoxa 40mg/0.4ml Recommended Recommended Product Decision recorded
Pharma, Injection Pack Size approved, in 242nd Meeting
Karachi Each Pre-filled 2-Prefilled however,cGM upheld. Further, all
API in syringe contains:- syringes in P / COPP is firms will submit
LDPE bags Enoxaparin unit carton.
further sodium..40mg/ required of the Bio-comparability
packed in 0.4ml USP finished Drug data followed by
Al.foil (Antithrombotic manufactured regular Pharmaco-
packs (Drug agent) using this vigilance report.
substance) (Local manufacture) particular drug
(in powder substance in
form) will
the country of
be imported
from M/s origin.
Hebei Biosimilarity
Changshan data of locally
Biochemical manufactured
Pharmaceuti drug needs to
cal Co., be disclosed by
Ltd.,
Shijiazhuan the local
g China for manufacturer.
local
formulation.
Biosimilar
of Clexane
of Sanofi.
211
5. Getz Enoxa Recommended Recommended Product Decision recorded
API (in syringe contains:- syringes in cGMP / COPP firms will submit
powder Enoxaparin unit carton.
form) will sodium..60 mg/ is required of Bio-comparability
be imported 0.6ml USP the finished data followed by
fr API in (Local manufacture) Drug regular Pharmaco-
LDPE bags manufactured vigilance report.
further using this
packed in particular drug
Al.foil
substance in
packs (Drug
substance) the country of
(in powder origin.
form) will Biosimilarity
be imported data of locally
from M/s manufactured
Hebei
drug needs to
Changshan
Biochemical be disclosed by
Pharmaceuti the local
cal Co., manufacturer.
Ltd.,
Shijiazhuan
g China for
local
formulation.
Biosimilar
of Clexane
of Sanofi.
212
6. Getz Enoxa Recommended Recommended Product Decision recorded
API in syringe contains:- syringes in cGMP / COPP firms will submit
LDPE bags Enoxaparin unit carton.
further sodium....80mg/ 0.8ml is required of Bio-comparability
packed in (Local manufacture) the finished data followed by
Al.foil Drug regular Pharmaco-
packs (Drug manufactured vigilance report.
substance) using this
(in powder particular drug
form) will
substance in
be imported
from M/s the country of
Hebei origin.
Changshan Biosimilarity
Biochemical data of locally
cal Co.,
drug needs to
Ltd.,
Shijiazhuan be disclosed by
g China for the local
local manufacturer.
formulation.
Biosimilar
of Clexane
of Sanofi.
213
7. Getz Pharma, Gilia solution for Recommended Recommende Approved, Decision
Karachi injection Pack Size d however, recorded in
API in LDPE Glatiramer acetate 1ml pre-filled cGMP / COPP 242nd
bags further 20mg/ml syringe in is required of Meeting
packed in Each ml contains: Pack of 1x1 and
Al.foil packs Glatiramer acetate the finished upheld.
1x3 cartridges
(Drug 20mg Drug Further, all
in unit pack.
substance) (in (Local Manufacture) manufactured firms will
lyophilized using this submit Bio-
powder form) particular drug comparabilit
will be substance in y data
imported from
the country of followed by
M/s Hybio
Pharmaceutical origin. regular
Co. Ltd, Biosimilarity Pharmaco-
No.37, Keji C. data of locally vigilance
Str. 2nd, manufactured report.
Shenzhen Hi- drug needs to
Tech Industrial be disclosed
Park China for
by the local
local
formulation. manufacturer.
8. Getz Pharma, Lira Solution for Recommended Recommende Approved, Decision

Karachi injection Pack Size d however, recorded in
API in LDPE 6mg/ml Solution for 3ml pre-filled cGMP / COPP 242nd
bags further Injection in Cartridge syringe in
is required of Meeting
packed in Each 1ml contains:- Pack of 1x1 and
Al.foil packs Liraglutide (free-base 1x3 cartridges the finished upheld.
(Drug anhydrous)...6mg in unit pack. Drug Further, all
substance) (in (Anti Diabetic) manufactured firms will
lyophilized (Local manufacture) using this submit Bio-
powder form) particular drug comparabilit
will be substance in y data
imported from
M/s Hybio
Pharmaceutical origin. regular
Co. Ltd, Biosimilarity Pharmaco-
No.37, Keji C. data of locally vigilance
Str. 2nd, manufactured report.
Shenzhen Hi- drug needs to
Tech Industrial
be disclosed
Park for local
by the local
formulation.
manufacturer.
214
9. Getz Menocon Recommended Recommende Product Decision
Pharma, Lyophilized Powders Pack size d approved, recorded in
Karachi for Injection 1000 IU 2ml in vial along however, 242nd
Naked filled USP with 2ml of
cGMP / COPP Meeting
glass vials Each vial contains:- 0.9%
containing Human Chorionic is required of upheld.
Sod.Chloride
lyophilized Gonadotropin injection(diluent
the finished Further, all
powder for USP..........1000 IU ) packed in Drug firms will
injection will (Bulk import local 1x1s unit manufactured submit Bio-
be imported repack) carton using this comparabilit
from M/s 1x5s unit particular drug y data
Shanghai carton substance in followed by
Livzon 1x10s unit
Pharmaceutica the country of regular
carton origin. Pharmaco-
l Co. Ltd,
No.1150, Biosimilarity vigilance
Guiqiao Road, data of locally report.
Jinqiao Export manufactured
Processing
drug needs to
Zone, Pudong,
Shanghai, be disclosed
China and will by the local
be repacked manufacturer.
locally.
10. Getz Menocon Recommended Recommende Product Decision
Pharma, Lyophilized Powders Pack size d approved, recorded in
Karachi for Injection 5000 IU 2ml in vial along however, 242nd
Naked filled USP with 2ml of cGMP / COPP Meeting
glass vials Each vial contains:- 0.9%
containing Human Chorionic is required of upheld.
Sod.Chloride
lyophilized Gonadotropin injection(diluent
powder for USP..........5000 IU ) packed in Drug firms will
injection will (Gonadotropins and 1x1s unit manufactured submit Bio-
be imported ovulation stimulants) carton using this comparabilit
from M/s (Bulk import local 1x5s unit particular drug y data
Shanghai repack) carton substance in followed by
Livzon 1x10s unit
carton origin. Pharmaco-
l Co. Ltd,
Processing drug needs to
Zone, Pudong,
locally.
215
11. Getz Menoget Recommended Recommende Product Decision
Pharma, Menotropins 75IU Pack size d approved, recorded in
Karachi /2ml vial 2ml in vial along however, 242nd
Naked filled Each vial contains: with 2ml of 0.9%
cGMP / COPP Meeting
glass vials Menotropins USP Sod. Chloride
containing 75IU (Human is required of upheld.
injection(diluents
lyophilized menopausal ) packed in
powder for gonadotrophin) 1x1s unit carton Drug firms will
injection will (Gonadotropins and 1x5s unit carton manufactured submit Bio-
be imported Ovulation stimulants) 1x10s unit using this comparabilit
from M/s (Bulk import local particular drug y data
carton
Shanghai repack)
substance in followed by
Livzon
l Co. Ltd, origin. Pharmaco-
Processing
drug needs to
Zone, Pudong,
locally.
12. Getz Menoget Recommended Recommende Product Decision
Pharma, Menotropins 150IU / Pack size d approved, recorded in
Karachi 2ml vial 2ml in vial along cGMP / COPP 242nd
Naked filled Each vial contains: with 2ml of 0.9% is required of Meeting
glass vials Menotropins USP Sod. Chloride
containing 150IU (Human the finished upheld.
injection(diluents
lyophilized menopausal ) packed in
Drug Further, all
powder for gonadotrophin) 1x1s unit carton manufactured firms will
injection will (Gonadotropins and 1x5s unit carton using this submit Bio-
be imported Ovulation stimulants) 1x10s unit particular drug comparabilit
from M/s (Bulk import local substance in y data
carton
Shanghai repack)
Livzon
Pharmaceutica origin. regular
l Co. Ltd, Biosimilarity Pharmaco-
No.1150, data of locally vigilance
Guiqiao Road, manufactured report.
Jinqiao Export drug needs to
Processing be disclosed
Zone, Pudong,
Shanghai, by the local
China and will manufacturer.
be repacked
locally.
216
13. Getz Pharma, Neupeginjection Recommended Recommende Product Decision
Karachi Pack size d approved, recorded in
Pegylated Each Pre-Filled syringe 6mg/0.6ml in however, 242nd
filgrastim will contains:- prefilled syringe
cGMP / COPP Meeting
be imported in Pegfilgrastim..6m 1x1s in unit
liquid form(as g/ 0.6ml (GCSF) is required of upheld.
carton.
bulk processed (Local manufacture) the finished Further, all
intermediate) Drug firms will
(in plastic manufactured submit Bio-
bottle made of using this comparabilit
PETG particular drug y data
material) from
M/s Beijing
Kawin the country of regular
Technology origin. Pharmaco-
Share-Holding Biosimilarity vigilance
Co., Ltd, No.6 data of locally report.
Rongjing East manufactured
Street, BDA,
drug needs to
Beijing, China
for further be disclosed
formulation by the local
locally. manufacturer.
14. Getz Pharma, Getiferon Recommended Recommende Product Decision

Karachi Solution for Pack size d approved, recorded in
API (in Injection 3MIU/ 1ml vial however,cGM 242nd
concentrated 3 MIU in Vials 1x1sin unit
P / COPP is Meeting
solution form) Each vial contains:- carton
required of the upheld.
will be Recombinant Human 1x5s in unit
imported (in Interferon Alfa 2a carton
finished Drug Further, all
plastic bottle .3x106 IU EP. manufactured firms will
made of PETG (Local manufacture) using this submit Bio-
material) from particular drug comparabilit
M/s Beijing substance in y data
Kawin
Technology
Share-Holding origin. regular
Co., Ltd, No.6 Biosimilarity Pharmaco-
Rongjing East data of locally vigilance
Street, BDA, manufactured report.
Beijing, China drug needs to
for local be disclosed
formulation.
by the local
manufacturer.
217
Karachi Solution for Injection Pack size d approved, recorded in
API (in 5MIU in Vials Each 5MIU/ 1ml vial however, 242nd
concentrated vial contains:- 1x1sin unit
cGMP / COPP Meeting
solution form) Recombinant Human carton
will be Interferon Alfa 2a 1x5s in unit is required of upheld.
imported (in 6
5x10 IU EP carton
plastic bottle (Local manufacture) Drug firms will
made of PETG manufactured submit Bio-
material) from using this comparabilit
M/s Beijing particular drug y data
Kawin
Technology
Share-Holding the country of regular
Co., Ltd, No.6 origin. Pharmaco-
Rongjing East Biosimilarity vigilance
Street, BDA, data of locally report.
Beijing, China manufactured
for local
drug needs to
formulation.
be disclosed
by the local
manufacturer.

API (in Injection 3MIU/ 1ml in however,cGM 242nd
concentrated 3 MIU in Pre-Filled pre-filled syringe
P / COPP is Meeting
solution form) Syringes Each Pre- in
required of the upheld.
will be Filled Syringe 1x1sin unit
imported (in contains:- carton
finished Drug Further, all
plastic bottle Recombinant Human 1x5s in unit manufactured firms will
made of PETG Interferon Alfa 2a carton using this submit Bio-
material) from .3x106 IU EP particular drug comparabilit
M/s Beijing (Local manufacture) substance in y data
Kawin
Technology
for local be disclosed
formulation.
by the local
manufacturer.
218
API (in Injection 5 MIU/ 1ml in however, 242nd
concentrated 5 MIU in Pre-Filled pre-filled syringe
cGMP / COPP Meeting
solution form) Syringes Each Pre- in
will be Filled Syringe is required of upheld.
1x1sin unit
imported (in contains:- carton
plastic bottle Recombinant Human 1x5s in unit Drug firms will
made of PETG Interferon Alfa 2a carton manufactured submit Bio-
material) from .5x106 IU EP using this comparabilit
M/s Beijing (Local manufacture) particular drug y data
Kawin
Technology
for local
drug needs to
formulation.
be disclosed
by the local
manufacturer.
18. Getz Pharma, Uniferon Solution Recommended Recommende Product Decision

Karachi for Injection Pack size d approved, recorded in
API (in 3 MIU in Vials Each vial of however, 242nd
concentrated Each vial contains:- 3MIU/ ml
cGMP / COPP Meeting
solution form) Recombinant Human 1x1s in unit
will be Interferon Alfa is required of upheld.
carton
imported (in 2b.3x106 IU EP 1x5s in unit
plastic bottle (Local Manufacture) carton Drug firms will
made of PETG manufactured submit Bio-
material) from using this comparabilit
Kawin
Technology
for local drug needs to
formulation.
be disclosed
by the local
manufacturer.
219
19. Getz Pharma, Uniferon Solution Recommended Recommende Approved, Decision
Karachi for Injection Pack size d however, recorded in
API (in 5 MIU in Vials Each vial of cGMP / COPP 242nd
concentrated Each vial contains:- 5MIU/ ml
is required of Meeting
solution form) Recombinant Human 1x1s in unit
will be Interferon Alfa the finished upheld.
carton
imported (in 2b.5x106 IU EP 1x5s in unit
Drug Further, all
plastic bottle Local manufacture carton manufactured firms will
made of PETG using this submit Bio-
material) from particular drug comparabilit
Kawin
Technology
for local
be disclosed
formulation.
by the local
manufacturer.
20. Getz Pharma, Uniferon Solution Recommended Recommende Product Decision

Karachi for Injection Pack size d approved, recorded in
API (in 3MIU in Pre-Filled Each prefilled however, 242nd
concentrated Syringe syringe of
cGMP / COPP Meeting
solution form) Each Pre-Filled 3MIU/ ml
will be Syringe contains:- is required of upheld.
1x1s in unit
imported (in Recombinant Human carton the finished Further, all
plastic bottle Interferon Alfa 2b Drug firms will
made of PETG ..3x106 IU manufactured submit Bio-
material) from (Local manufacture) using this comparabilit
Kawin
Technology
for local drug needs to
formulation.
be disclosed
by the local
manufacturer.
220
21. Getz Pharma, Uniferon Solution for Recommended Recommende Product Decision
Karachi Injection Pack size d approved, recorded in
API (in 5MIU in Pre-Filled Each prefilled however,cGM 242nd
concentrated Syringes Each Pre- syringe of
P / COPP is Meeting
solution form) Filled Syringe 5MIU/ ml
will be contains:- required of the upheld.
1x1s in unit
imported (in Recombinant Human carton finished Drug Further, all
plastic bottle Interferon Alfa 2b manufactured firms will
made of PETG .5x106 IU using this submit Bio-
material) from (Local manufacture) particular drug comparabilit
Kawin
Technology
for local
be disclosed
formulation.
by the local
manufacturer.
Case No.02
M/s Macter, Karachi: Keeping in view the facilities and quality control of the above listed products,
the panel recommends the registration of these products to the firm. The panel also recommends the
registration of Prance (imported labeled vials) under the condition that the firm will establish their own
facilities for biological activity test of the same product within six months period.
221
Applicant Product Specifications Recommendations Decision of Decision of Decision of
of the PSI Panel DRB the Board in the Board in
Subcommittee its 242nd its 243rd
Meeting Meeting
22. Macter Heberon 2a Injection Recommended Recommended Approved, Decision

International 3MIU/0.3ml. Pack Size however, recorded in
Limited, (Liquid Solution) Each 1x1s vial cGMP / COPP 242nd Meeting
Karachi vial contains:- is required of upheld.
(API Import in rh-Interferon alpha 2a
concentrated bulk ...3MIU/ 0.3ml the finished Further, all
from M/s Beijing (Local manufacture) Drug firms will
Shuanglu manufactured submit Bio-
Pharmaceutical using this comparability
Company Ltd, particular drug data followed
China and local substance in by regular
formulation at
the country of Pharmaco-
M/s Macter
International, F- origin. vigilance
216, SITE, Biosimilarity report.
Karachi) data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
23. Macter Heberon 2a Injection Recommended Recommended Approved, Decision

International 5MIU/0.5ml. Pack Size however,cGMP recorded in
Limited, Karachi (Liquid Solution) Each 1x1s vial / COPP is 242nd Meeting
(API Import in vial contains:- required of the upheld.
concentrated bulk rh-Interferon alpha 2a
from M/s Beijing .5MIU/ 0.5ml finished Drug Further, all
Shuanglu (Local manufacture) manufactured firms will
Pharmaceutical using this submit Bio-
Company Ltd, particular drug comparability
China and local substance in data followed
formulation at the country of by regular
M/s Macter
origin. Pharmaco-
International, F-
216, SITE, Biosimilarity vigilance
Karachi) data of locally report.
manufactured
drug needs to
be disclosed by
the local
manufacturer.
222
24. Macter Heberon 2a Injection Recommended Recommended Product Decision
International 3MIU/ml Pack Size approved, recorded in
Limited, Karachi (Lyophilized Powder) 1x1s vial however, 242nd Meeting
(API Import in Each vial contains:-
cGMP / COPP upheld.
from M/s Beijing .3MIU/ ml is required of Further, all
Shuanglu (Local manufacture) the finished firms will
Pharmaceutical Drug submit Bio-
Company Ltd, manufactured comparability
China and local using this data followed
formulation and particular drug by regular
freeze-drying at
substance in Pharmaco-
M/s Macter
International, F- the country of vigilance
216, SITE, origin. report.
Karachi) Biosimilarity
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
25. Macter Heberon 2a Injection Recommended Recommended Product Decision

International 5MIU/ml Pack Size approved, recorded in
Limited, Karachi (Lyophilized Powder) 1x1s vial however, 242nd Meeting
cGMP / COPP upheld.
from M/s Beijing 5MIU/ml is required of Further, all
Shuanglu (Local manufacture) the finished firms will
Pharmaceutical Drug submit Bio-
Company Ltd, manufactured comparability
China and local using this data followed
formulation and particular drug by regular
freeze-drying at
substance in Pharmaco-
M/s Macter
International, F- the country of vigilance
216, SITE, origin. report.
Karachi) Biosimilarity
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
223
26. Macter Peg-In Injection Recommended Recommended Product Decision
International 50mcg /0.5ml Pack Size approved, recorded in
Limited, (Lyophilized Powder) 1x1s vial however cGMP 242nd Meeting
Karachi Each vial contains:-
/ COPP is upheld.
(API Import in Pegylated rh-Interferon
concentrated bulk alfa 2b.50mcg) required of the Further, all
from M/s Intas finished Drug firms will
Pharmaceuticals (Local manufacture) manufactured submit Bio-
Ltd, India and using this comparability
local formulation particular drug data followed
and freeze-drying substance in by regular
at M/s Macter
International,
F-216, SITE, origin. vigilance
Karachi) Biosimilarity report.
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.

Limited, Karachi Each vial contains:- 1x1s vial however cGMP 242nd Meeting
(API Import in Pegylated rh-Interferon
/ COPP is upheld.
concentrated bulk Alfa 2b..80mcg
from M/s Intas (Lyophilized powder required of the Further, all
Pharmaceuticals for injection) finished Drug firms will
Ltd, India and (Local manufacture) manufactured submit Bio-
local formulation using this comparability
and freeze-drying particular drug data followed
at M/s Macter substance in by regular
International,
F-216, SITE,
Karachi) origin. vigilance
Biosimilarity report.
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
224
Limited, Karachi (Lyophilized Powder) 1x1s vial however cGMP 242nd Meeting
/ COPP is upheld.
concentrated bulk Pegylated rh-Interferon
from M/s Intas alfa required of the Further, all
Pharmaceuticals 2b..100mcg/0.5ml finished Drug firms will
International,
F-216, SITE,
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.

/ COPP is upheld.
Pharmaceuticals 2b....120mcg/0.5ml finished Drug firms will
International,
F-216, SITE,
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
225
/ COPP is upheld.
Pharmaceuticals 2b150mcg/0.5ml finished Drug firms will
International,
F-216, SITE,
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
31. Macter Neupeg Recommended Recommended Product Decision

International 6mg/ml Injection Each Pack Size approved, recorded in
Limited, Karachi vial contains:- 1x1s vial however cGMP 242nd Meeting
(API Import in Pegfilgrastim
/ COPP is upheld.
concentrated bulk ..6mg/0.5ml
from M/s Intas (Local manufacture) required of the Further, all
Pharmaceuticals finished Drug firms will
Ltd, India and manufactured submit Bio-
at M/s Macter particular drug data followed
International, F- substance in by regular
216, SITE,
Karachi)
origin. vigilance
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
226
32. Macter PranceInjection Recommended Recommended Product Decision
International, Each vial contains: Pack Size approved, recorded in
Karachi. Recombinant Human 1x1s vial however cGMP 242nd Meeting
Labeled Vials Basic Fibroblast
/ COPP is upheld.
imported from Growth
M/s. Beijing Factor35000IU required of the Further, all
Shuanglu (Growth Factor). finished Drug firms will
Pharmaceutical manufactured submit Bio-
Co., China and using this comparability
local re- particular drug data followed
packing at substance in by regular
M/s. Macter
International,
Karachi. origin. vigilance
(Import of Biosimilarity report.
labelled vials data of locally
and local manufactured
repacking) drug needs to
be disclosed by
the local
manufacturer.
33. Macter MacgrastimInjection Recommended Recommended Product Decision

International, Pre-filled Syringe Pack Size approved, recorded in
Karachi. Each ml contains:- 1x1s vial however cGMP 242nd Meeting
Import of Filgrastim (rhG-
/ COPP is upheld.
labeled PFS CSF).300ug
from M/s. (Immunomodulator). required of the Further, all
Beijing finished Drug firms will
Shuanglu manufactured submit Bio-
pharmaceutical using this comparability
Co., China and particular drug data followed
local re- substance in by regular
packing at
M/s. Macter
International, origin. vigilance
Karachi. Biosimilarity report.
data of locally
manufactured
drug needs to
be disclosed by
the local
manufacturer.
227
Case No. 03
M/s Hilton, Karachi: Based on the above observations the Panel recommends the grant of
registration of Injection Filgrastim only. For the rest of the products the firm is asking for more time till
the installation of freeze drying facilities.
Applicant Product Recommendations Decision of Decision of Decision of the

specifications of the PSI Panel DRB the Board in Board in its
Subcommittee its 242nd 243rd Meeting
Meeting
34. Hilton Lameo Injection 3 Deferred for Deferred for Deferred. Decision
Pharma MIU lyophilizer lyophilizer cGMP / COPP recorded in
(Pvt)Ltd., Each vial contains:- installation and installation is required of 242nd Meeting
Karachi. Interferon alfa- verification. and the finished upheld.
Concentrate 2b3 MIU verification.
Drug
import from: (Lyophilized).
M/s Nanogen manufactured
Pharmaceutical (Local using this
Biotechnology manufacture) particular drug
Co., Ltd. substance in
Vietnam and the country of
local
origin.
formulation
and filling at Biosimilarity
Hilton Pharma data of locally
(Pvt) Ltd., manufactured
Karachi. drug needs to
be disclosed
by the local
manufacturer.
228
35. Hilton Lameo Injection 5 Deferred for Deferred for Deferred. Decision
Pharma (Pvt) MIU lyophilizer lyophilizer cGMP / COPP recorded in
Ltd., Karachi. Each vial contains:- installation and installation is required of 242nd Meeting
Concentrate Interferon alfa- verification. and upheld.
the finished
import from: 2b5 MIU verification.
M/s Nanogen (Lyophilized). Drug
Pharmaceutical (Local manufactured
Biotechnology manufacture) using this
Co., Ltd. particular drug
Vietnam and substance in
local the country of
formulation
origin.
and filling at
Hilton Pharma Biosimilarity
(Pvt) Ltd., data of locally
Karachi. manufactured
drug needs to
be disclosed
by the local
manufacturer.
36. Hilton Xiro Injection Recommended Recommended Approved, Decision

Pharma (Pvt) Each ml contains:- however, recorded in
Ltd., Karachi. Filgrastim cGMP / 242nd Meeting
Concentrate ...300ug COPP is upheld.
import from: required of Further, all
M/s Biocon, (Local the finished firms will
Banglore. manufacture) Drug submit Bio-
India manufactured comparability
formulation using this data followed
and filling at particular by regular
Hilton Pharma drug Pharmaco-
(Pvt) Ltd., substance in vigilance
Karachi. the country report.
of origin.
Biosimilarity
data of
locally
manufactured
drug needs to
be disclosed
by the local
manufacturer.
Decision in 242nd Meeting: The Board after through discussion on the import and use of raw material for
the drug substance noted with concern that only those raw material should be imported and used that are
also in use for the manufacture of finished drug in the country of origin; this is mandatory in order to safe
guard the health of the patients and to avoid experimentation on local population. Further it was agreed
229
that the existing products already in the market also need to be evaluated on similar pattern by the
Committee constituted earlier i.e.,
1. Gen Gen (R) Karamat A Karamat Member Registration Board

2. Brig (R) Muzammil H Najmi Member Registration Board
3. Dr. Muhammad Arshad Member Registration Board
4. Mr. A.Q. Javid Iqbal Director QA, DRAP, Islamabad.
5. Mr.Sheikh Ansar Ahmed Director, DBER, DRAP, Islamabad.
*Area FID will co-ordinate the inspection.
Decision in 243rd Meeting: Decision recorded in 242nd Meeting upheld.
Case No. 04: New license for local manufacture by M/s Nextar Pharma (Pvt) Limited,
Karachi:
M/s Nexter Pharma (Pvt) Limited, Karachi has communicated to this Division on Feb 01, 2014 that
they have received the DML No. 000777 on 15th March 2013 for the local manufacture of Biological
Drugs by way of formulation. The firm has acquired the technology from the United Nations
International Centre for Genetic Engineering and Biotechnology (Italy).
Applicant Product Present Decision of the Decision of the

specifications registration Board in its 242nd Board in its 243rd
status Meeting Meeting.
37. M/s Nextar Nexfil 150 NIL Approved, however, Decision recorded in
Pharma Injection cGMP / COPP is 242nd Meeting
(Pvt) Ltd., Each Prefilled required of the upheld. Further, all
arachi syringe finished Drug firms will submit
Concentrate contains: manufactured using Bio-comparability
import from: Filgrastim 150 this particular drug data followed by
M/s Pooyesh mcg (B.P.)/ml substance in the regular Pharmaco-
Darou, Co., country of origin. vigilance report.
Ltd., Tehran Shelf life 2 Bio-similarity data of
Iran and years locally manufactured
local filling Storage +2 to drug needs to be
and packing. +8 C disclosed by the local
Pack size 1x1 manufacturer.
PFS
Recombinant
Human
Granulocyte
Colony
Stimulating
Factor
230
38. M/s Nextar Nexfil 300 Reg No. Approved, Decision recorded in
Pharma (Pvt) Injection 041123 for however,cGMP / 242nd Meeting
Ltd., Karachi Each Prefilled import in COPP is required of upheld. Further, all
Concentrate syringe finished the finished Drug firms will submit
import from: contains: form manufactured using Bio-comparability
M/s Pooyesh Filgrastim 300 this particular drug data followed by
Darou, Co., mcg (B.P.)/ml substance in the regular Pharmaco-
Ltd., Tehran Pack size 1x1 country of origin. vigilance report.
Iran and PFS Biosimilarity data of
local filling Shelf life 2 locally manufactured
and packing. years drug needs to be
Storage +2 to disclosed by the local
+8 C manufacturer.
Recombinant
Human
Granulocyte
Colony
Stimulating
Factor
39. M/s Nextar Pegaron Reg No. Approved, Decision recorded in
Pharma (Pvt) Injection 059281 for however,cGMP / 242nd Meeting
Ltd., Karachi Each prefilled import in COPP is required of upheld. Further, all
Concentrate syringe finished firms will submit
the finished Drug
d pegylated contains: form Bio-comparability
interferon Pegylated manufactured using data followed by
alpha 2a will Interferon alpha this particular drug regular Pharmaco-
be imported 2a- 180mcg/ml substance in the vigilance report.
from: Pack size 1x1 country of origin.
M/s Pooyesh PFS Biosimilarity data of
Darou, Co., Shelf life 2 locally manufactured
Ltd., Tehran years
drug needs to be
Iran and Storage +2 to
local filling +8 C disclosed by the local
and packing. manufacturer.
Antiviral agent
231
40. M/s Nextar NP-POETIN Reg No. Approved, Decision recorded in
Pharma (Pvt) 2000 047557 for however,cGMP / 242nd Meeting
Ltd., Karachi INJECTION import in COPP is required of upheld. Further, all
Concentrate Each prefilled finished the finished Drug firms will submit
import from: syringe form manufactured using Bio-comparability
M/s Pooyesh contains: this particular drug data followed by
Darou, Co., Erythropoietin substance in the regular Pharmaco-
Ltd., Tehran 2000IU country of origin. vigilance report.
Iran and (B.P.)/ml Biosimilarity data of
local filling Pack size 1x1 locally manufactured
and packing. PFS drug needs to be
Shelf life 2 disclosed by the local
years manufacturer.
Storage +2 to
+8 C
Hamatopoietic
agent
41. M/s Nextar NP-POETIN Reg No. Approved, Decision recorded in
Pharma (Pvt) 4000 047558 for however,cGMP / 242nd Meeting
Ltd., Karachi INJECTION import in COPP is required of upheld. Further, all
Concentrate Each prefilled finished the finished Drug firms will submit
import from: syringe form manufactured using Bio-comparability
M/s Pooyesh contains: this particular drug data followed by
Darou, Co., Erythropoietin substance in the regular Pharmaco-
Ltd., Tehran 4000IU country of origin. vigilance report.
Iran and (B.P.)/ml Biosimilarity data of
local filling Pack size 1x1 locally manufactured
and packing. PFS drug needs to be
Shelf life 2 disclosed by the local
years manufacturer.
Storage +2 to
+8 C
Hamatopoietic
agent
Past Decision in 242nd Meeting: The Board relied upon the inspection report of the license panel that had
confirmed the presence of the technology and expertise along with GMP compliance of the facility for the
above mentioned product and allowed the registration. It was also noted that this firm had no other
products except the ones mentioned above for manufacture in the newly licensed facility.
Past Decision in 243rd Meeting: Decision recorded in 242nd Meeting upheld
Two honourable members of the Registration Board has forwarded their comments which are as under: -
A. Dr. Amanullah Khan (Director, DTL, Quetta)
232
a. The matter regarding biological products of the inspected firms have been discussed in length and
the entire board is of the opinion to first safe guard the health of our patients and then encourages
our pharmaceutical industry for the transfer of biological technology to manufacture safe and
quality biological products for the country. However nobody is allowed to use the lives of our
country man for experimental basis, therefore all the biological drugs manufactured in the country
should be safe and effective to treat the ailment of our people. As all we know that scientifically
we have capable and well equipped pharmaceutical companies in the country which are in a
position to carry out manufacture of safe and quality biological products in the country.
b. The Draft minutes of 243 DRB to my understanding is to submit COPP/GMP and bio comparable
data and I also understand that bio-comparability refers to in-vitro-comparison which is
acceptable. But it is beyond my understanding that why it is written that the 242 nd DRB decision
is upheld and it needs clarification because the decision of 242nd minutes in biological products
was not approved by majority of the board members. Therefore, changes should be made and
decision of 243RB should supersede the decision made in 242 nd RB for biological products.
B. Mr. Abdul Razzaq (Director, DTL, Karachi).
c. Please remove the decision made in 242nd Registration Board meeting for biological as it was
quarantined, uphold only decision made in 243rd Registration Board meeting. Decision made for
biological products only those raw material should be imported and used that are also in use for
the manufacture of finished drug in the country of origin should be suspended, since there are
number of products which are developed by companies for export purpose only and they are
marketing these products internationally. Similarly we have given privilege to manufacturer in
Pakistan that for meeting export requirements of a local manufacturer or a foreign pharmaceutical
company, drug can be contract manufactured but such drugs shall not be sold in Pakistan.
Considering the sensitivity of the matter the cases is placed before the Registration Board for
scientific discussion, consensus and precise decision so that the above mentioned applications for
registration are dealt accordingly.
Decision (Case No.1-4):
Decision: Registration Board discussed above cases 1-4 and decided as under:
a) Biosimilarity is the principal requirement for the registration of biological drugs, as it is

part of requirements of DRAP Act, 2012 mainly focusing on patient safety and also to
promote biological production and availability of biological products.
b) All those manufacturing units which have been approved by Central Licensing Board for
manufacturing of biological drug and also had qualified product specific inspection by
panel of Registration Board, are allowed registrations of applied biological drugs for local
manufacturing on case to case basis. Items for which product specific inspection is required,
then it will be conducted by already constituted panel of Registration Board.
233
c) Local manufacturer will provide legalized documents from concerned regulatory body
confirming the status of licensed manufacturer of concentrate / bulk source in its country of
origin. Moreover manufacturer will provide legalized documents for confirmation that
finished product is also available in market from the same biological material. Case will be
processed for issuance of registration letter and the Board authorized its Chairman for
permission to issue registration letter after fulfillment of above mentioned requirements,
with following conditions:
i. Registrations is exclusively for trial manufacturing of the drug and manufacturer

shall not be allowed in any way to sale / utilize these trial manufactured drugs.
Manufacturer will perform biosimilarity studies as per WHO guidelines confirming
the biosimilarity of applied product to original innovator product.
ii. Manufacturer will submit actual result of conducted biosimilarity studies to the
Biological Division for its scientific evaluation through Expert Committee on
Biological Drugs (ECBD). Moreover manufacturer will also provide sufficient
quantity of these trial manufactured drugs to Biological Division for testing by
National Control Laboratory for Biological (NCLB) as per WHO guidelines.
iii. Recommendation of ECBD and report of NCLB will be submitted to Registration

Board for permission of commercial manufacturing of the product or otherwise.
d) This decision supersedes all the already taken decisions so far in the earlier meetings of
Registration Board on the subject cases.
Case No.05
M/s Amson Vaccine and Pharma, Rawalpindi applied for issuance of Registration letter
for their product namely DTwp-rHepB-Hib pentavalent vaccine approved in 240th Meeting of the
Registration Board without mentioning the price for EPI/Government supply only.
Perusal of minutes of 240th Meeting of DRB, the following anomalies are observed.
i) The volume of injection of single dose is 1 ml at one place (Column-iii, Annex-I) and
01(one) ml and 0.5ml in Column-iv, whereas in CoPP and Form-5 the volume is 0.5ml
for each dose.
ii) As per CoPP provided the product is shown in the Column where the product is in the
market of India, and on Form 5-A, it is written that the product is yet to be marketed (The
firm has clarified that the product is on market in India).
The case is presented before the Drug Registration Board for approval of changes in composition
and issuance of registration letter.
Decision: Typographic correction approved as per COPP and legal documents of the dossier.
234
Case No.06
M/s Novo Nardisk has applied for the change of source of their registered product namely
Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the Registration Board in
its 242nd meeting is as follows: -
S.No. Product & API Existing Proposed

Regn.No. Manufacture secondary secondary
Site packaged packaged
import site import site
1 Insulatard Penfill Novo Novo Nordisk Novo Nordisk
Nordisk A/S A/S Production S.A.S.
100 IU/ml 5x3 ml Novo Alle Novo Alle 5 bis, rue Edmond
(R.No. 010341) DK-2880 DK-2880 Poillot
Bagsvaerd Bagsvaerd 28000 Chartres
Denmark Denmark France
Past Decision: The Board approved the new EMA approved site mentioned above for import of the
above mentioned products subject to COPP from new site.
Accordingly the change of source letter was issued to the firm on 7 th April, 2014 clearly mentioning that
the previous source of import stands cancelled. The Assistant Drugs Controller, Karachi has informed that
M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M (Reg NO. 010341) from Denmark
on 20th May, 2014 which is the earlier source of import. The ADC, Karachi was requested to submit
complete case along with his recommendations. The ADC Karachi has stated that he is of the opinion to
revoke the orders of sales restrictions as the safety, quality and economic value of drug in question. The
officer has also stated that sale of the drug may be allowed in the public interest so required.
It is submitted that the source of import was cancelled by the Drug Registration Board vide letter No. 2-
1/2014-DDC (BD)(M-242), dated 7th April, 2014. Under section 23 subsection 1(a) (vii) no person shall
himself or by any other person on his behalf export, import or manufacture for sale or sell any drug
which is not registered or is not in accordance with the conditions of registration. The firm has violated
the Drugs Act, 1976.
Decision: Registration Board approved request of the firm. However the Board advised firm to
provide / submit copy of L/C (original or duly certified) for establishing the fact that the import
order was placed well before the date of grant of change of manufacture site by DRAP and
authorized its Chairman for permission to issue the letter for sale of drug.
235
Case No. 07 M/s Macter International (Pvt) Ltd., Karachi - Case of import of Interferon
from Cuba instead of China:
The firm was originally given registration of Heberon Alfa R 2-b Registration No.
047675 manufactured by M/s Heber Biotec, Havana, Cuba, latter on the firm requested the
changed of its source to M/s Changchun Heber Biological Technology Co., Ltd, China on
21.03.2011. Recently the firm has imported two lots of Interferon from Cuba instead of China
hence its lot release was stopped, the firm was directed to remove all stocks from market.
It is suggested that since the change of source or any other correction on the registration
letters are issued as separate letter it is almost impossible for NCLB to know what deviation
have been allowed. Therefore all such modifications are to be printed on the revised
Registration Letter with original information as well as revised information for complete record,
the original Registration Letter shall be considered cancelled however the original registration
number and the date of registration shall remain the same.
Case was reported for further guidance by the Board: i)in terms the penalty to the
firm, ii) the fate of the lots imported, and iii) the suggestion given above on how to handle the
modification in the registration letters for all firms to avoid confusion or benefit claimed by the
firms by fooling the import offices.
Decision: Registration Board decided that DDG(E&M), DRAP Karachi will investigate the
and will submit the report matter within 15 days for consideration of Registration Board.
The DDG (E&M), Karachi has submitted the investigation report vide letter dated 28 th March,
2014. The report is as under: -
1) The initial registration of Bulk import and local packing for Heberon Alpha 3 MIU
(Interferon Alpha R 2-B 3MIU) (Registration no. 047675) was granted vide letter
No.F.3-1/2008-Reg-I (M-212), dated 04.08.2008 to M/s Macter International (Pvt)
Limited, Source: Heber biotec, S.A. La Havana, Cuba.
2) M/s Macter International (Pvt) Ltd, applied for the transfer of manufacturing site
from M/s Heber Biotec, S.A. La Havana, Cuba to M/s Changchun Heber Biological
Technology Co., Ltd., China which was granted vide leter No. F.1-49/2-10-Reg-I,
dated 21.03.2010.
3) M/s Macter International (Pvt) Limited also submitted renewal of registration from
the source: Heber biotec, S.A. Havana, Cuba which was received to concern
department (DDC, RRR, DRAP, Islamabad) on dated 18.07.2013 of said product
236
before 5 year of initial registration as per Drug Act, 1976 and the rules made
thereunder.
4) B#L33031/0 invoice no. 20136146 dated 22.03.2013 Mfg. dated July, 2013 and Exp.
Date July, 2015 was released by Cuban Regulatory Authority (CECMED) dated
09.072013 M/s Macter International (Pvt) Limited applied for the clearance of lot to
ADC, DRAP, Karachi and on the basis of documents provided the clearance was
provided on 01.08.2013.
5) National Control Laboratory for Biologicals (NCLB), DRAP, Islamabad issue the lot
release certificate (F.3-34/2007-NCL-2013/475). After receiving the lot release M/s
Macter International (Pvt) limited started marketing of this lot. NCLB issue a letter
No. F.3-34/2007-NCLB, dated 24.10.2013 to M/s. Macter International (Pvt) Ltd
subject to Batch recall and Cancellation of Lot release of Heberon Alpha 2-B on
the basis of transfer of registration granted to Macter from Cuba manufacturing site
to China manufacturing site. This letter was also copied to DDG (E&M), DRAP,
Karachi with instruction to confiscate all the stock and seal it till the decisi on of
competent authority. On the basis of which M/s Macter International (Pvt) Limited
recalled the remaining stock from the market.
6) I had visited M/s Macter International (Pvt) Limited dated 28.10.2013 and sealed the
balanced stock on Form I as per Drug Act 1976, section 18(i) & the rules made
there under at M/s Macter International (Pvt) Limited, in cold storage ware house
(Heberon Alfa R 3MIU liquid injection, Reg. no. 047675, B# L33031/0 Qty. 20836
vials, manufactured by M/s Herber Biotec Havana, Cuba. The stock could not be
confiscated due to the technical reason as the product require cold storage
system/condition (2o to 8oC) which is not maintainable in the office of undersigned.
7) M/s. Macter International (Pvt) Limited also requested Chairman, Quality Control
Board via letter No.NIL to consider their case sympathetically and de-sealed and
allow them to market the stock.
Findings
During the course of investigation following questions/issues have been arose/assessed
by the undersigned, under WHO, ICH guidelines and the prevailing Drug Act and the rules
framed thereon: -
1. Whether any safety issue? No.
2. Whether any Efficacy issue? No.
3. Whether any Quality issue? No.
4. Whether any Price issue? No.
5. Whether Government Analyst can withdraw his batch release certificate? No.
6. Whether registration of the drug in question is valid or otherwise? Valid under
Rule 27 of the Drug (Registration, Licensing & Advertising Rules, 1976.
7. Whether the action of the Director (Biologicals for confiscation was lawful? No.
8. Whether the quality Assurance authorities name and address of marketing
authorization holder are same? Yes.
9. Whether till today any order are passed by the concerned section on renewal
application under the rule 26 and 27 of Drug( Registration, Licensing &
Advertising) Rules, 1976?No.
10. Whether the change of manufacturing site and source became a question mark
now? Yes.
237
After careful investigation of the case as per advice of registration board I hereby submit my
conclusion that M/s Changchun Heber Biological Technology Co., Ltd., China is the sister
concern of M/s Heber Biotech, S.a. La Havana, Cuba the basis approved site and the product
release authority of both the sources Cuba and Chinais same. Hence, there is no product Safety,
Quality, Efficacy and Economic value related issue found. As the lot was released by NCLB,
Islamabad also and the importer (M/s Macter International (Pvt) Limited applied for the renewal
of the said product on form 5-B of the rule 26 of the Drug renewal for registration on
18.07.2013 and also deposited the required fee under SRO 1117(I)/2012 which is pending with
RRR section, DRAP. Therefore there is no harm to allow them to market the aforesaid lot in
favour of the importer in public interest so required as protected under rule 27 of the Drugs (Lic.
Reg. and Adv.) Rules, 1976. Furthermore, it is noticed that other conditions as laid down in the
original registration certificate are also found enacted.
CONCLUSION: -
A) Keeping in view the foregoing fact the benefit of doubt to the Importer, who could now
only retain the original source as per certificate of registration and administrative order
vide letter NO.F.1-49/2011-Reg-I, dated 21st March, 2011 become automatically void,
after the implementation of rules 27 of the Drugs (Lic. Reg. and Adv.).
B) The action taken by Director (NCLB) DRAP vide his letter No.F. 3034/2007-NCLB may
be withdrawn and furthermore order made by the undersigned in concurrence with the
foregoing instruction may also made void by the honorable board as it became time
barred ultimately under the Drug Act, 1976 and DRAP Act, 2012.
C) Allow the importer to consume the remaining stock of aforesaid lot available in their
cold chain system, with the warning to refrain such practices in future.
D) The suggestions made by the then Director (Biologicals) may be further assessed by a
committee of the experts previously engaged in the registration issue; who can easily
make it easy for any amendment, correction, change or any other relevant update in
revised registration certificate issued time to time. Several changes, correction or
amendment made under administrative letters will become unlawful in the eyes of law.
The case along with investigation report is placed before the Drug Registration Board for considering
the legal aspects, provisions of section 23 1(a) (vii) of Drugs Acts, 1976 and rules frame thereunder and
decision please.
Decision: Registration Board discussed the matter in detail and advised investigation officer to
further clarify following points:
a) On which documents the firm obtained clearance of Heberon Alfa R 2-b Registration No.
047675 from DRAP, Karachi along with dates of invoice, airway bill/ BL, LC date and
other relevant information.
b) After grant of approval of change of source, what is legal status of renewal application
submitted by the firm from previous source?
238
c) What is the status of recall of stocks, the legal course of holding/ restricting the stocks from
sale was followed or otherwise, after not to dispose of order on Form-1 dated 28.10.2013?
Case No. 08. M/s Eli Lilly Pakistan (Pvt) Limited, Karachi has submitted following application
regarding change of source from Egypt to Indianapolis, USA
M/s Eli Lilly Pakistan (Pvt) Ltd., Karachi had submitted the following application on Form 5-A, along
with Fee Rs. 50,000/- per product and CoPP from new source. The details are as under: -
S.# Product & Existing Manufacturing Site New Manufacturing

Registration and Source of Supply Site and Source of
No. Supply
1. Humulin N M/s Eli Lilly Egypt, 6th October Eli Lily and Company
100IU vial Reg City 2nd Industrial Zone, Plot Indianapolis, IN 46285,
No. 008300 No.1, Cairo, Egypt USA.
2. Humulin R M/s Eli Lilly Egypt, 6th October Eli Lily and Company
100IU vial Reg City 2nd Industrial Zone, Plot Indianapolis, IN 46285,
3. Humulin 70/30 M/s Eli Lilly Egypt, 6th October Eli Lily and Company
100iu vial Reg City 2nd Industrial Zone, Plot Indianapolis, IN 46285,
Decision: Registration Board approved the change of source as per CoPP provided by the firm.
Case No. 09. M/s Ali Gohar (Pvt) Limited, Karachi has submitted application regarding change
of source from Germany to Spain.
M/s Ali Gohar (Pvt) Ltd., Karachi had submitted the following application on Form 5-A, along with Fee
Rs. 50,000/- and CoPP from new source. The detail is as under: -
S.# Product & Existing Packaging Site and New Packaging Site
Registration Source of Supply and Source of Supply
No.
1. Humalog 10 Lilly Pharma, Fertigung and Lilly S.A.
IU/ml vial Distribution GmbH & Co. KG Adva. De la Industria
35387 Giessen, Germany. 30, 28108 Alcobendas,
Madrid, Spain.
Manufacturing site will remain the same as Eli Lilly & Company, Indianapolis, IN 46285, USA.
Decision: Registration Board approved the change of packaging site as per CoPP provided by the
firm.
239
Case No. 10.
M/s Excel Health Care, Karachi has applied for registration of their following products.
The company have deposited an amount of Rs 100,000/- against each product: -
Sl. No. Applicant Product Specifications

1 Excel Health Care Laboratories MENSTROL
(Pvt) Ltd, Karachi (Levonorgestrel: 05
Estradiol 2mg)
2 Excel Health Care Laboratories FEMININ
(Pvt) Ltd, Karachi (Cyproterone Acetate 2mg &
ethinyloestradiol 35mcg)
3 Excel Health Care Laboratories MENOCARE
(Pvt) Ltd, Karachi (Estradiol valerate and
cyproterone acetate)
4 Excel Health Care Laboratories ANDROL
(Pvt) Ltd, Karachi (Cyproterone Acetate 50mg)
5 Excel Health Care Laboratories GESTON INJ
(Pvt) Ltd, Karachi (Natural Progesterone)
6 Excel Health Care Laboratories GONACOR INJ 2000IU
(Pvt) Ltd, Karachi (Human Chorionic
Gonadotropin)
7 Excel Health Care Laboratories GONACOR
(Pvt) Ltd, Karachi (Human Chorionic Gonadotropin
5000IU)
8 Excel Health Care Laboratories HMG MASSONE
(Pvt) Ltd, Karachi (Human Menopausal
Gonadotropin 75IU)
9 Excel Health Care Laboratories HMG MASSONE
(Pvt) Ltd, Karachi (Human Menopausal
Gonadotropin 150IU)
10 Excel Health Care Laboratories MENORIN 0.3mg
(Pvt) Ltd, Karachi (Conjugated Estrogen)
Excel Health Care Laboratories ENDRALIN
(Pvt) Ltd, Karachi (Alarelin 150ug-Gnrh)
11 Excel Health Care Laboratories LUTRONE INJ 100UG
(Pvt) Ltd, Karachi (Gonadorelin 10s)
The applications were considered in 237 th meeting of Drug Registration Board for non SRA
countries. The case is also considered 4 th ECBD meeting, in which agenda was deferred for non
SRA country. Meanwhile inspection was conducted for GMP compliance. The panel has
confirm the GMP compliance of the firm
The products related to human biological originating from countries that do not have
stringent regulatory authorities.
240
Decision: The Registration Board decided to defer the subject, being incomplete. Moreover case
will be re-considered by Registration Board after recommendation of ECBD.
Case No.11 Miscellaneous Agenda
a. Suite No. 871 of 2014 in the honorable High Court of Sindh at Karachi.
M/s Ghazi Brother, Karachi has filed a suit against IZO SPA, Italy and Drug Regulatory
Authority of Pakistan, the Secretary Registration Board, The Drug Controller and The Director
Biological Drugs. M/s IZO SPA, Italy has terminated the sole company agreement with Ghazi
Brother, Karachi and has incorporated their local branch at Lahore. M/s Ghazi Brother has
challenge the termination letter currently 40 products are registered in the name of M/s Ghazi
Brother Karachi and 08 products are under process of registration. Primarily the case is a
business deal between two companies. However, parawise comments on behalf of Drug
Regulatory Authority of Pakistan, The Secretary Registration Board and Director Biological has
been prepared and shall be responded with due course of time through Law and Justice Division.
Decision: Registration Board advised to proceed as per procedure.
b. In the High Court of Sindh Karachi Constitution petition no. D-2190/2014
Constitution petition No. D-2190/2014 is filed by Mr. Javed Iqbal, Son of Mohammed Din,
Muslim, adult, resident of 14/10, 4A, Nazimabad and Syed Sarwer Javed Son of Syed Nadeem
Bumi, Muslim, adult, resident of R-75, Gulshan e Shamim, Yasinabad, F.B. Area, Karachi
against
1. Federation of Pakistan, 2 The Drug Regulatory Agency of Pakistan,

Through the Secretary, Body Corporate established
Ministry of National Regulations and under Section 3 of the
Services LG & RD Complex, 2nd Floor, Drug Regulatory Agency of Pakistan,
Behind State Bank of Pakistan, G/5-2, Ordinance, 2012, having its offices at
Islamabad Block C, 2nd Floor, Pak Secretariat,
Islamabad.
3. The Registration, 4. Roche Pakistan Limited (Importer),
A Statutory body established A company incorporated
For the Registration of drug, under the Company Ordinance,1984,
Under Section 7 of the Drug Act, 1976, having its registered office at 37-C,
Through its Chairman, having its office Block-6, PECHS, Karachi.
241
at Pakistan Secretariat, Islamabad.
The patitationer has challenged the grant of registration for Ropegra on the ground that the same
product cannot be registered from the same manufacturer under different brand name and
different prices. The case is also highlighted in the print media.
Decision: The matter was discussed in detail under Item No. II of instant agenda and the same
decision is applicable.
Item No.VIII Quality Control cases
Case No.01: New Cases
Sr. Name of Firm CDL Report Appellate Testing Detail / Decision

No Drugs
1. Famocide M/s Mediways, Sub-Standard with Sub-Standard with The Board was apprised
Suspension, International, regard to:- regard to background of the case as
under:-
Batch No. Lahore i. Assay for
Famotidine 61.46% Samples drawn from
818 i. Assay for manufacturers premises
Famotidine Limit 90% to 110% on 19-06-2013 by FID
(F.No.03- 78.23% Faisalabad at Lahore.
45/2013-QC) Limit 90% to 110% Does not comply Declared substandard vide
with USP 32 test report No.
Does not comply
LIP.549/2013 dated 22-08-
2013.
The firm requested for
ii. pH appellate testing.
ii. pH
Determined 4.36 Declared substandard by
Determined 5.44
appellate lab vide test
Limit 6.5 to 7.5 report No. 021-
Limit 6.5 to 7.5
MNHRS/2013 dated 21-
Does not comply 11-2013.
Does not comply
Show Cause Notice dated
with USP 32
18th April 2014 issued, to
the firm and to the
following accused, for
violation of Section 23
(1)(a)(v) of D.A 1976:
i. Mr. Jamil Ahmed
(Chief (Executive and
242
production Incahrge)
ii. Ruksana Anjum
(Quality Control
Incharge)
As per responsibility fixed

by the FID, show cause
notices dated 18th April
2014 were issued to the
firm. Accused as identified
by FID Lahore were also
called for personal hearing
accordingly.
Decision:-
The Board in view of personal

hearing of Mr. Jamil Ahmed
(Chief (Executive and
production Incahrge) and
available record/facts of the
case decided as under:-
i. To Suspend the
registration of Famocide
Suspension (Registration No.
041874) of the firm for a
period of six months.
Moreover firm will recall all
stocks of substandard drug
from distribution / sale
outlets / institutional supply
(if any) and area FID shall
take report from firm and
submit compliance for
Board.
ii. The Board further

decided to inspect the
premises of the firm for
technical evaluation and a
panel comprising of Director
DTL Lahore, Director DTL
Quetta and Area FID was
constituted.
243
2. Gention Violet M/s Lahore Sub-Standard with Sub-Standard with The Board was apprised
B.P.C Pharma Lahore regards to: regard to: background of the case as
under:-
Batch No. 409 Light absorption test Assay of Gention
& 410 Violate 25.34% Samples drawn from
Determined 0.13 manufacturers premises
(F.No.03- Limits 90% to 110% on 1-04-2013 by ADC
34/2013-QC) Limits Not less than Lahore
0.32 Does not comply Declared substandard
with manufacturers vide test report No.
Does not comply specifications EXP.16/2013 dated 16-
with BPC 73 05-2013.
The firm requested for
appellate testing
Declared substandard by
appellate lab vide test
report No. 010-
MNRS/2013 dated 23rd -
07-2013.
The following
accused, for violation of
Section 23 (1)(a)(v) of
D.A 1976:
Muhammad Saeed,
Managing Partner,
M/s. Lahore Pharma
As per responsibility
fixed by the ADC, show
cause notices dated 21-
04-2014 & 16th May 2014
were issued to the firm.
Accused as identified by
ADC Lahore were also
called for personal
hearing accordingly.
Decision:-
i. The accused of the firm

were called for personal
hearing, but they could not
appear before the Board.
The Board decided to defer
the case and a final
opportunity of personal
244
hearing shall be given in
next meeting of the Board.
3. Furacare M/s Well Care Sub-Standard with Challenged but after The Board was apprised
Suspension Pharmaceutical regard to pH lapse of stipulated background of the case as
Batch No.021 Pvt Ltd period, which is not under:-
Sargodha Determined 4.71
tenable under
F.N0 3- Section 22(4) of The samples of Furacare
02/2014-QC Limits 6.0 to 8.5s Suspension Batch No. 021,
Drug Act 1976.
Does not comply Manufactured by M/s Well
Care Pharmaceuticals,
Sargodha drawn by FID
Lahore from manufacture
premises on 04-09-2013, was
declared Substandard vide
Test Report No.LIP.719/2013
dated 08-10-2013 by Federal
Government Analyst. The firm
has made request for appellate
testing but as per FIDs
comments the request was
time barred. The FID has
identified following persons
responsible in the case.
i. Malik Saeed Akhter,

(Management Director)
ii. Memoona
Anwar,Quality Control
Manager)
iii. Rai Muhammad
Sarfaraz, (Production
Manager)

by the FID Lahore, show
cause notice dated 06th May
2014 were issued to the firm,
and accused as identified by
FID Lahore were also called
for personal hearing
accordingly.
Decision:-

245
appear before the Board. The
Board decided to defer the
case and a final opportunity
of personal hearing shall be
given in next meeting of the
Board.
4. Stearox 1ml M/s Gyton Sub-Standard Not Challenged The Board was apprised
Pharmaceutical background of the case as
Injection Batch Lahore With regards to:- under:-
No. H110112
i. pH
The samples of Stearox
(F.No.03- Injection Batch No.
25/2013 QC) Determined 5.94
H110112, Manufactured by
Limit 7.0 to 8.5 M/s Guyton Pharmaceutical
Lahore drawn by FID
Does not comply Karachi from Central
Pharmacy of JPMC, Karachi
with USP 34
on 26-02-2013, was declared
Substandard vide test report
ii. Assay for
No.261/2013 dated 03-04-
Dexamethasone 2013 by Federal
Government Analyst. The
Phosphate 14.59%
FID has identified following
persons responsible in the
Limit 90% to 115%
case.
i. Mr. Talat Ahmad
Does not comply
with USP 34 Anjum (Q.C In-
charge)
ii.Muhammad Imran
Khalil
(Production In-charge)
As per procedure show

cause notices was issued to
the firm 20th February 2014
and above accused, offering
hearing before the Drug
Registration Board. They
were also called for
personal hearing
accordingly.
Decision:-

246
hearing shall be given in
next meeting of the Board.
5. Nitronil 34% M/s Manhattan Substandard with Not Challenged The Board was apprised
Injection, Pharma Karachi regards to:- background of the case as
Batch No. under:-
NT1011 i. pH
Determined 8.54 The samples of Nitronil
(F. No. 3- Injection Batch No. NT1011,
Limit 5.0 to 7.0 Manufactured by M/s
03/2014-QC
Does not comply Manhattan Pharma Karachi
drawn by FID Karachi-III
ii. Assay for from manufacturing
Nitoxynil 50.96% premises on 05-12-2013,
was declared Substandard
limit: 95.0% to vide test report No.992/2013
105.0% dated 28-01-2014 by Federal
Government Analyst. On
Does not comply FID explanation letter the
firm claimed to have
investigated and rectified the
problem. The FID has
concluded that the firm has
violated section 23 of Drugs
Act, 1976 and identified
following persons
responsible in the case.
i. Syed Ibnul Hasan
Hashmi, (Director of
the firm)
ii.Aga Nisar Ahmed,

(Q.C Analyst)
iii. Ailiya Mehdi,

(Production
Incharge)
iv. Naeema Khatoon,

(Production Icharge)
As per responsibility fixed by

the FID, show cause notices
247
dated 17-04-2014 were issued
to the firm and the accused
persons of the firm. They were
also called for personal
Decision:-

hearing of Mr Syed Ibnul
Hassan (Managing Partner &
QC Incharge) and available
record/facts of the case
decided as under:-
i. To suspend the
registration of Nitronil 34%
Injection, (Reg. No. 052366)
of the firm for a period of six
months. Moreover firm will
recall all stocks of
substandard drug from
distribution / sale outlets /
institutional supply (if any)
and area FID shall take
report from firm and submit
compliance for
consideration of
Registration Board.
ii. A panel comprising of

following member for
technical evaluation and
product specific inspection
of the firm was constituted
Director DTL, Karachi

Director DTL, Quetta
Area FID.
6. Kohsar DS M/s Kohs Substandard with Firm challenged the The Board was apprised
Tablets Pharmaceuticals regard to :- report after 30 days background of the case as
(Pvt) Ltd as per record under:-
Batch No.001 Assay for provided by FID so
Artemether: the request was not The Sample of Kohsar DS
248
Hyderabad. 80.256% valid for re testing Tablets Batch No. 001
by the Appellate manufacture by M/s Kohs
(F. No. 03- Limit: 90% to Lab NIH Islamabad Pharmaceuticals (Pvt) Ltd
63/2013) 110% Hyderabad, drawn on 10-10-
under section 22(5)
2013 from manufacturers
Does not comply of Drugs Act 1976 premises by FID Hyderabad,
was declared substandard by
Federal Government Analyst
CDL, Karachi vide Test
report No. 852/2013 dated
10-12-2013. The firm did
not respond FIDs
explanation letter dated 17-
12-2013 so reminder letters
dated 06-01-2014 and 30-01-
2014 were issued by the
FID. The firm vide its
response dated 11-02-2014
disagreed and challenged the
CDL report. As per record
provided by the FID the
report was conveyed to the
firm by the FID vide letter
dated 17th December 2013,
while the firm challenged the
report vide its letter dated
11th February 2014. The FID
nominated following as
responsible persons.
i. Owner of the firm, M/s
Kohs Pharmaceuticals
(Pvt) Ltd.,
ii. Quality Control Incharge
M/s Kohs
Pharmaceuticals (Pvt)
Ltd
iii. Mirza Saleemullah,

Production Manager, M/s
(Pvt) Ltd
The FID has not given any

recommendations nor made
any comments regarding
validity of the act of
challenging the CDL report
by the firm. However, as
per record provided by the
FID, it appears that firm
249
has challenged the report
after the 30 days period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.

notices dated 05-05-2014
were issued to the firm and
the accused persons of the
firm. They were also called
accordingly.
Decision:-

hearing shall be given in next
meeting of the Board.
7. Dozabitol M/s Kohs Sub-Standard:- Firm challenged the The Board was apprised
Syrup Pharmaceuticals report after 30 days background of the case as
(Pvt) Ltd With regard to assay as per record under:-
Batch No. DB for Paracetamol provided by FID so
110 Hyderabad
the request was not The Samples of Dozabitol
82.2984% Syrup, Batch No. DB110
valid for re testing
(F.No. 03- manufacture by M/s Kohs
12/2014)-QC Limit:- 90% to 110% by the Appellate
Pharmaceuticals (Pvt) Ltd
Lab, NIH Islamabad Hyderabad, drawn on 10-10-
Does not comply under section 22(5) 2013 from manufacturers
of Drugs Act 1976 premises by FID Hyderabad,
were declared substandard
by Federal Government
Analyst CDL Karachi vide
Test report No. 848/2013
dated 27-11-2013. . In
response to FIDs
explanation letter, the firm
disagreed and challenged the
CDL report. As per record
250
provided by the FID the
report was conveyed to the
firm by the FID vide letter
dated 03rd December 2013
and reminder was issued
vide letter dated 30-01-2014
for firms response in the
matter. The firm challenged
the report vide its letter
received in DRAP Karachi
office on 13-02-2014. so the
request for retesting was not
valid as the same was
received by FID office after
30 days The FID has
nominated following as
responsible persons.
(Pvt) Ltd.,
ii. Quality Control

Incharge, M/s Kohs
Ltd
iii. Mirza Saleemullah,

Production Manager,
M/s Kohs
Ltd
The FID has not given any

recommendations nor made
any comments regarding
validity of the act of
challenging the CDL report
by the firm. However, as
per record provided by the
FID, it appears that firm
has challenged the report
after the 30 days period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.
by the FID, show case
251
accordingly.
Decision:-

appear before the Board. The
Board decided to defer the
case and a final opportunity
of personal hearing shall be
given in next meeting of the
Board
8. Dozabitol M/s Kohs Sub-Standard with Sub-Standard The Board was apprised about
Syrup Pharmaceuticals regard to:- the background of the case
(Pvt) Ltd With regard to:- as under:-
Batch No. DB Assay for i. Assay for
DB 089 Hyderabad Paracetamol:- The Sample of Dozabitol
88.62% paracetamol:- Syrup Batch No. DB089
(F.No. 03- manufacture by M/s Kohs
31/2013)-QC 85.52% Pharmaceuticals (Pvt) Ltd
Hyderabad, drawn on 21-03-
Limit:- 95.0% to Does not comply 2013 from manufacturer
105% with BP 2011. premises by FID Hyderabad,
was declared substandard by
Does not comply ii. Description pink Federal Government
with BP 2011 colored syrup Analyst, CDL Karachi vide
having un dissolved Test report No. 535/2013
masses which do not dated 06-05-2013. On
disperse even on explanation letter issued by
shaking the FID, the firm requested
Appellate testing under
section 22(5) of Drugs Act
1976. The Appellate
Does not comply Laboratories also declared
the sample sub-standard vide
with BP 2011,
test report No.08-
which states that MNHRS/2013 dated 06th
suspension may August 2013. The repot of
show a Appellate Laboratories was
sedimentation which forwarded to the FID for
is readily dispersed sending complete case along
on shaking. with recommendation and
name of the responsible
252
persons. The FID in
response has nominated
following as responsible
person with request for
permission for prosecution
and cancellation of
registration.
(Pvt) Ltd., Hyderabad.
ii. Miss Rakhshanda Perveen

(Quality Control Manger).
iii. Production Manager of the

firm

accordingly.
Decision:-

hearing shall be given in next
meeting of the Board.
9. Benzirin-C M/s Adamjee Sub-Standard with Sub-Standard with The Board was apprised about
Mouth Wash Pharmaceuticals regard to:- regard to:- the background of the case
(Pvt) Ltd as under:-
Batch No. 70. Karachi. i. pH Assay for
Determined 4.76 Cetylpyridinium Sample of Benzirin-C Mouth
(F.No.03- Choloride 159.94% Wash Batch No 70,
04/2014-QC) Limits 5.0 to 7.0
manufactured by M/s Adamjee
Does not comply Limit:-90% to 110% Pharmaceutical (Pvt) Ltd
Karachi was taken by FID-III,
Does not comply
with manufacturers Karachi, on 23-12-2013 from
ii. Assay for manufacturers premises. It
253
Benzydamine HCL specifications. was declared substandard by
Federal Government Analyst,
84.666% CDL Karachi vide Test report
Limit:- 90.0% to No. 1013/2013, dated 28-01-
110% 2014. On explanation letter
issued by the FID, the firm
Does not comply challenged the CDL report and
requested for Appellate
Testing under Section 22(5) of
Drugs Act, 1976. The
Appellate Laboratory also
declared the sample as
Substandard vide their test
report 02-MNHRS/2013 dated
24-04-2014. The FID has
concluded that the
manufacturer is guilty of
manufacturing substandard
drug and has requested for
prosecution of the following
persons of the firm in Drug
Court along with cancellation
of the registration of the
product under reference.
i. M/s Adamjee
Pharmaceutical Pvt Ltd
Karachi
ii. Farooq Hamirani,
Managing Director,
iii. Shahid Ahmed Khan
Production Manager,
iv. Asim Kamal Ansari
QA Manger,
the FID, show cause notices
dated 11-06-2014 were issued
to the firm and the accused
persons of the firm. They were
also called for personal
Decision:-
254
hearing of Mr. Asim Kamal
Ansari QC Incharge of the
firm and available record/facts
of the case decided as under:-
i. To conduct product
specific inspection and
evaluation of firms Quality
Assurance system by the
following panel.
a. Director QA/LT,
b. Area FID
c. Director DTL
Karachi
The report of the panel shall
be presented before the
Board in its next meeting.
10. Polybion Z Merck Sub-Standard with Sub-Standard with The Board was apprised about
Capsules Pharmaceutical regards to:- regard to:- the background of the case
(Pvt) Ltd Disintegration Time as under:-
Batch No. 461 Disintegration Time
Karachi Does not comply The sample of Polybion Z
(F. No. 3- with manufacturers Determined 02 capsules, Batch No. 461,
26/2012) specifications Hours 45 minutes Manufactured by M/s Merck
(Pvt) Limited, Karachi for
Limit:- Not more Merck (Pvt) Ltd, Quetta
than 30 minutes drawn by ADC Quetta from
premises of M/s Merck Pvt
Does not comply Ltd., 7-Jail Road, Quetta for
with manufacturers Test/Analysis on 26-09-
specifications 2012, was declared
substandard vide test report
No. EXP.44/2012 dated 10-
12-2012 by Federal
Government Analyst. CDL
Karachi. On firms request,
the Boards portion of
samples was sent for
Appellate Testing. The
Appellate Lab also declared
the samples substandard vide
test report No. 016-
MNHSR/2013 dated 21-11-
2013. The ADC has
forwarded names of
following responsible
persons of the firm as
255
accused.
i. Mr. Abdul Nasir Khan,
Site Director C/o

Merck Pharmaceuticals
(Pvt) Ltd., S.I.T.E
Karachi.
ii. Mr. Syed Akhtar
Hussain, Qualified
Person /QA Manager
iii. Mr. Muhammad Bilal,
Store In-charge
iv. Mr. Ashraf Memon
QC Manager
v. Ms. Shehnila Mubeen
Qualified Person/
Production In-charge
the FID, show casue notice dated
20-02-2014 was issued to the
firm and the accused persons of
the firm. They were also called
for personal hearing accordingly.
Decision:-

hearing of Mr. Abdul Nasir
Site Director and Mr. Syed
Akhter Hussain (QA Manager)
of the firm and available
record/facts of the case
decided as under:-
i. To suspend the registration

of Polybion Z Capsules (Reg.
No. 039495) of the firm for a
period of 03 months.
Moreover firm will recall all
stocks of substandard drug
from distribution / sale
outlets / institutional supply
(if any) and area FID shall
take report from firm and
submit compliance for
256
Board.
ii. The Board constituted a

panel comprising of Director
QA/LT, Area FID and
Director DTL Karachi to
inspect the premises for
product specific inspection.
Case No.02: Manufacture and supply of sub-standard Hepaferon Injection by M/S Pharmedic,
Lahore to Govt of Khyber Pakhtun Khawa
BRIEF BACK GROUND: The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with
reference to the decision taken in also 243rd meeting of Registration Board which is reproduced as under.
i The Federal Inspector of Drugs Peshawar is advised to get the case completed covering
details of findings, conclusion fixation of responsibilities with his recommendations.
ii. The Board further decided to get update regarding Suo Moto notice taken by Hounrable
Peshawar High Court Peshawar and fate of case referred to NAB Khyber Pakhtoon
Khawa.
The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of
persons accused in manufacture and sale of substandard Hepaferon Injection Batch No 80-87. The FID
has also submitted the suo moto judgment a copy of Honorable High Court Peshawar but did not
submitted the report regarding investigation by NAB.
Name of accused persons.
i. Mr. Iftikhar Ahmed Shiekh Director/C.E.O

ii. Mr. Mazhar Hussain Production Incharge.
iii. Mr. Asim Mehmood Quality Control Inchage
Name of Co-accused persons.
Dr. Chuhan Director
Dr. Sharif, Director
Dr. Ghulam Subhani Director Hapatitis Program
Mubarik Shah, Store Keeper LRH Hapatitis Program
Dr. Nigar Ahmed, Ms DHQ Mardan.
Mr. Aurengzaib, Store Incharge, DHQ Mardan.
Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic
Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection
Hepaferon (3MIU) Interferon Alpha 2a to government of Khyber Pakhtoon Khawa.
Case No.03: Deaths of persons allegedly due to consumption of cough syrup manufactured by
M/S Ethical Laboratories Pvt Ltd and M/S Reko Pharmecal Laboratories
257
The case of M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore was apprised to the
Board regarding their request received on 21-07-2014 with reference to the decision of the Board taken
in 243rd meeting of Registration Board. The Board desired that a complete case may be presented before
the Board highlighting all the previous background of the subject case so that decision may be taken
accordingly.
Item No.IX. Medical Devices.
Case No.0I. Applications for registration of medical devices (import).
Registration Board considered the following applications of medical

devices for import and decided as mentioned against each. Approved applications have already
been recommended by Expert Committee on Medical Devices and are subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:-
A: CATHETERS:
S.No. Name of Importer and Name of Medical Price of Shelf Decision
Manufacturer/Exporter. Device. Medical Device life
(s)
1. M/s Johnson & Johnson Empira RX PTCA Decontrolled till 2 Approved.

Pakistan (Pvt) Limited, Dilatation Catheter policy decision years
Karachi. by the Policy
Balloon Dia (mm) :
Board/Federal
Legal Manufacturer:
1.50, 2.00, 2.25, Government
M/s Creganna Tactx 2.50, 2.75, 3.00,
Medical, Inc, 1353 Dell 3.25, 3.50,
Ave,Campbell, CA, USA. 3.75,4.00.
Assembler: Balloon Length:

(mm): 6, 10, 12, 15,
M/s Creganna Tactx 20, 25, 30.
Medical, Pte Ltd, 8
Admiralty Street # 7-10, Different product
Adamirax Singapore. codes available.
2. M/s Johnson & Johnson Empira NC RX Decontrolled till 2 Approved.

Pakistan (Pvt) Limited, PTCA Dilatation policy decision years
Karachi. Catheter by the Policy
Board/Federal
Legal Manufacturer:
Government
258
M/s Creganna Tactx Balloon Length
Medical, Inc, 1353 Dell Ave, (mm): 6, 10, 12, 15,
Campbell, CA, USA. 20, 25, 30.
Assembler: Balloon Dia (mm):

1.50, 2.00, 2.25,
M/s Creganna Tactx 2.50, 2.75, 3.00,
Medical, Pte Ltd, 8
3.25, 3.50, 3.75,
Admiralty Street # 7-10, 4.00.
Adamirax 757438,
Singapore. Different product
codes available.
3. M/s. B.Braun Pakistan (Pvt) SeQuent Neo Rapid Decontrolled till 02 Approved.
Ltd., Exchange Coronary policy decision years
(PTCA) Balloon by the Policy
The Forum, Suit 216, Catheter. Board/Federal
Khayaban-e-Jami, Clifton Government
Block-9, Karachi. Balloon Dia.(mm):
1.25. 1.5, 2.0, 2.25,
Legal Manufacturer:
2.5, 2.75, 3.0, 3.5,
M/s. B.Braun Melsungen 4.0.
AG, Carl-Braun-Strasse 1,
Balloon Length
34212 Melsungen, Germany. (cm): 10, 15, 20,
Manufacturing Site: 25, 30.
B. Braun Melsungen AG, Different product

Vascular Systems, codes available.
Sieversufer 8, 12359 Berlin,
Germany.
4. M/s. B.Braun Pakistan (Pvt) Coroflex ISAR Decontrolled till 2 Approved.

Ltd., policy decision years
(Sirolimus Eluting by the Policy
The Forum, Suit 216, Polymer-Free Board/Federal
Khayaban-e-Jami, Clifton Coronary Stent Government
Block-9, Karachi. System)
Legal Manufacturer:
M/s. M/s. B.Braun
259
Melsungen AG, Carl-Braun- Stent Dia (mm)
Str.1, 34212 Melsungen,
2.0, 2.25, 2.5, 2.75,
Germany.
3.0, 3.5, 4.0.
Manufacturing Site:
Stent Length (mm).
B. Braun Melsungen AG,
8,9,13,14,16,19,24,
Vascular Systems,
27,32.
Sieversufer 8, 12359 Berlin,
Germany. Different product
codes available.
5. M/s Ghazali Brothers, Hospital & Decontrolled till 05 Approved.

Homecare Silicon policy decision years
1st Floor Azzainab Court, Foley. by the Policy
Campbell Street, Karachi. Board/Federal
Silicon Foley
Manufactured by Government
Without Balloon
Hospital and Homecare for Children:
Medical Devices Co., Ltd. 6,8,10,12.
N0.1088,East Hongsheng Silicon Foley
area, Science and Without Balloon
Technology Zone XinBa
for Adult:
Town YangZhong City, 14,16,18,20,22,24.
China.
Silicon Foley with
Balloon for
Children 2 way:
6,8,10,12.
Silicon Foley with

Balloon for Adult 2
way:
14,16,18,20,22,24.
Silicon Foley with

Balloon for adult
3 way:
16,18,20,22,24.
260
6. M/S Zenith International, Perfect Fine Decontrolled 5 years Rejected as
Room No.104,Tahir Plaza, A- Disposable till policy the
20 Block 7 & 8, K.C.H.S.U, Silicone Foley decision by manufacturer
Karachi Manufactured by: Balloon Catheter the Policy has cancelled
(Type 2way) Board/Federal the sole
M/s Hospital & Homecare
Government agency
Medical Device Co. Ltd. (Urology agreement.
No.1088, East Hongsheng Catheter)
Area, Science and Technology
Sizes:
Zone, Xinba Town,
Yangzhong City, China (6FR, 8FR, 10FR,
12FR, 16FR,
18FR, 20FR,
22FR, 24FR,
26FR, 28FR,
30FR)
7. M/s Ghazali Brothers, Hospital & Decontrolled 5 years Approved.

Homecare Latex till policy
1st Floor Azzainab Court,
Foley Catheter decision by
Campbell Street, Karachi. the Policy
(1 way, 2way & 3 Board/Federal
Manufactured by: way) Government
M/s Yangzhong Jinxiang
(6G,8G,10G,12G,
Emulsion Products Co. Ltd, 14G, 16G,18G,
No.88 Daqiao Road, 20G,22G,
Yangzhong, Jiangsu, China. 24G,26G)
8. M/S Zenith International, Trucath Foley Decontrolled 5 years Approved

Room No. 104, Tahir Plaza, Balloon Catheter till policy subject to
A/20, Block 7 & 8, K.C.H.S.U, decision by prevailing
Karachi. Balloon Length the Policy import policy
(mm): 220, 360.
Board/Federal order
Manufactured by: Government regarding
Balloon Dia
M/s Sutures India Pvt.Ltd., (mm): 2.0, 2.7, import from
Plot No.13-16, KIADB 3.3, 4.0, 4.7, 5.3,
261
Industrial Area, 6.0, 6.7, 7.3, 8.0, India.
Kalanayakkanahalli, Kunigal 8.7, 9.3, 10.0.
Taluk, Tumkur District,
2way sizes:
Karnataka, India.
6FR, 8FR, 10FR,
12FR, 14FR,
16FR, 18FR,
20FR, 22FR,
24FR, 26FR,
28FR, 30FR
3 way sizes:
14FR, 16FR,
18FR, 20FR,
22FR, 24FR,
26FR
9. M/s. A. Feroz & Co., Pigeon Latex Decontrolled 3 years Approved.

Medicine Street No.1, Marriot Foley Balloon till policy
Road, Karachi. Catheter decision by
the Policy
Manufactured by 1way/2way/3way.
Board/Federal
M/s. Nantong Angel Medical (6Fr, 8Fr, 10Fr, Government
Instruments Co, Ltd, Fusheng 12Fr, 14Fr, 16Fr,
Road, Xiayuan Town, Rugao 18Fr, 20Fr, 22Fr,
City, Jiangso Province, China. 24Fr, 26Fr, 28Fr)
Exported by
M/s. Sinobright Import &

Export Co., Ltd., China
B. SYRINGES
S.No. Name of Importer and Name of Medical Price of Medical Shelf Decision
Manufacturer/Exporter. Device Device (s) life
262
1. M/s Tech Zone, Set Inject Decontrolled till 5 Approved
Disposable policy decision by years .
764, Street 24, Zarar Syringe the Policy
Shaheed Road, Askari IX Board/Federal
Lahore Cantt. 2 ml, 5 ml, 10 ml Government
Manufactured by: 20ml
M/s Set Medikal A.S, With 18G, 19G,

Istiklal Mah, Maresal 20G, 21G, 22G,
Fevzi Cakmak, Cad. 23G, 25G, 26G,
No.18 34522 Esenyurt- 27G Needle.
Istanbul, Turkey.
Case No.02. Registration applications of medical devices already registered with other
importing firms.
The following firms applied for registration of products mentioned against each.
These products have already been registered with other firms as mentioned below. Registration
Board considered the applications and rejected the applications due to reasons as mentioned
against each.
S.No. Name of Importer and Name of Medical Price of Shelf Decision

Manufacturer/Exporter Device Medical Device life
(s)
1. M/s Lab Link Safelet Cath Decontrolled till 5 Rejected as the

Enterprises, Intravenous Canula policy decision years same product
192-N, Block-II, PECHS, Pen Type by the Policy from same
Board/ Federal manufacturing
Karachi. Government site is already
Manufacturer & Sizes: registered with
Headquarter: M/s Lab Link
G- Enterprises,
Nipro Corporation, 3-9-3, 14,16,18,20,22,24. Karachi.
Honjo-Nishi, Kita-ku,
(50 per box)
263
Osaka 531-8510, Japan.
2. M/s Lab Link Nipro Disposable Decontrolled till 5 Rejected as the

Enterprises, Syringe policy decision years same product
192-N, Block-II, PECHS, by the Policy from same
Karachi. Government site is already
(1ml, 2ml, 3ml,
Manufactured by registered with
5ml, 10ml, 20ml) M/s Lab Link
M/s Nipro (Thailand) Enterprises,
Co., Ltd, 10/2 Moo 8, Karachi.
Bangnomko, Sena, Phra
Nakorn Si Ayuthaya
13110, Thailand.
3. M/s Lab Link Nipro Disposable Decontrolled till 5 Rejected as the

Enterprises, Syringe policy decision years same product
192-N, Block-II, PECHS, by the Policy from same
Karachi.
(30ml, 50ml, Government site is already
Manufactured and 60ml) registered with
Headquarter: M/s Lab Link
Enterprises,
Nipro Corporation, 3-9-3, Karachi.
Honjo-Nishi, Kita-ku,
Osaka 531-8510, Japan.
4. M/s. Leckman Health LMS TM Decontrolled till 02 Rejected as the

Care Pvt Ltd, Karachi. Disposable policy decision years product is already
Infusion Set by the Policy registered with
Manufactured by: Board/ Federal M/s Genome
M/s. Shandong Weigao Government Pharmaceuticals
Group Medical Polymer Hattar,
Co., Ltd. Shandong. incomplete
China. registration
application
dossier and
differential fee
not deposited.
264
5. M/s. Leckman Health LMS TM Decontrolled till 2 Rejected as the
Care Disposable policy decision years product is already
Syringe by the Policy registered with
Pvt Ltd, Karachi.
(1cc, 3cc, 5cc, Board/ Federal M/s Genome
Manufactured by 10cc Government Pharmaceuticals
Hattar,
M/s. Shandong Weigao 20cc) incomplete
Group Medical Polymer registration
Co., Ltd. Shandong. application
China. dossier and
differential fee
not deposited.
6. M/s Asia Link Asia Link Decontrolled till 05 Rejected as the

International Suit # 4, International policy decision years same product
Ground Floor , Dashtayar Syringes. by the Policy (1ml, 3ml, 5ml,
Pride, Block 13-D-I, Board/ Federal 10ml, 20ml) of
Gulshan-e-Iqbal Government same
Karachi.. (1ml, 3ml, 5ml, manufacturer is
10ml, 20ml, 50ml, already registered
Manufactured by:
60ml) with M/s Medico
M/s Huaian City International,
Hengchun Medical Karachi and
Product Co. Ltd.,No 8 differential fee
Yanhuang Street New not deposited.
Industrial Zone, Lianshui
County Jiangsu,
China.
7. M/s Hashir Surgical Auto Disable Decontrolled 5 Rejected as the

Services (Pvt) Ltd, Syringe (Revital) years Auto Disable
Syringe is
1st Floor, House No.16,
already registered
Street 1, Sector F-2,
(2ml, 3ml, 5ml) with M/s A.J.
Phase-6, Hayatabad, Mirza Pharma
Peshawar
(Pvt) Ltd,
265
Manufactured By: Karachi.
M/s Revital Healthcare

(EPZ) Ltd, Mombasa,
Kenya.
Case No.03. Withdrawal of registration applications of medical devices.
The following importing firms applied for withdrawal of their registration

applications of medical devices as mentioned against each.
S.No. Name of Importer and Name of Medical Device (s) Reasons/Remarks of

Manufacturer/Exporter importing firms.
1. M/s Intek Corporation, Rawalpindi. Genous Bioengineered R We are withdrawing the

Stent registration request of
Legal Manufacturer: product and further action
(Stent coated with a bio- on this product is no more
M/s. OrbusNeich Medical, Inc.5363 compatible matrix)
NW 35th Ave Fort Lauderdale, FL, required.
USA.
Manufacturing Location:
M/s. OrbusNeich Medical B.V. Drs,
W. Van Royenstraat, AN
Hoevelaken, The Netherlands.
2. -do- R Stent Evolution 2 -do-

Coronary Stent System
(Coronary Stent System)
3. -do- Genous Bioengineered R -do-

Stent
(Stent coated with a bio-

compatible matrix)
4. M/s Atco Pharma International (Pvt) Alviguide TM Cardiovascular Approved in 237th

Ltd, Karachi-75700. Guiding Catheter meeting of DRB. Now the
firm has stated that they
Manufactured by are not interested for
registration of this product
M/s Alvimedica Tibbi Urunler San.
because the manufacturer
Ve Dis. Tic. A.S. Istanbul, Turkey.
has stopped the
266
production of the said
product.
5. M/s Syah Impex, Karachi. Shifa Disposable Retractable We hereby withdraw our
Safety Syringe product. This is for your
Manufactured by: information & record.
M/s Jiangxi Sanxin Medtec Co. Ltd,
999 Fushan Road, Xiaolan Economic 0.5 ml
Development Zone, Nanchang
Jiangxi, China.
Decision: Registration Board considered the request of the firms for withdrawal of their
applications for registration of above mentioned medical devices and approved
the request.
Case No.04. Miscellaneous cases.
a) Shelf life of Medical Devices.
The Registration Board agreed to the recommendations of the ECMD that in case of
imported products, the applicants should provide duly attested registration certificate and
document mentioning shelf life of the product from the regulatory authority of the country of
origin (translated in English) in addition to the stability data required according to Form 5-A.
b) Change of Manufacturing Site from Germany to Vietnam.
M/s B. Braun Pakistan (Pvt) Ltd, Karachi requested for change of production site
of their following registered medical devices as tabulated below:-
S.# Regn. Name of Product Existing New Manufacturing Site

No. Manufacturing Site
1 073280 Intrafix Primeline B.Braun Melsungen AG B.Braun Veitnam Co., Ltd,

(IV Administration Carl-Braun-Strabe 1, Thanh Oai Industrial
Set by Gravity and 34212 Melsungen, Complex, Thanh Oai
Compatible Pump) Germany. District, 156800 Hanoi,
Vietnam.
267
2 073281 Intrafix Safeset -do- -do-
(IV Administration
Set by Gravity and
Compatible Pump)
M/s B. Braun Pakistan (Pvt) Ltd, Karachi intimated that the production site of
above mentioned products has been shifted from B. Braun, Germany to B.Braun Vietnam Co.
Ltd., and requested for approval of new source i.e. B.Braun Veitnam Co., Ltd, Thanh Oai
Industrial Complex, Thanh Oai District, 156800 Hanoi, Vietnam. The firm submitted the
following documents in respect of above mentioned products:-
(i) Application on Form 5-A for both products.

(ii) Fee of Rs.100,000/- for each product.
(iii) Free Sale Certificate (original) from the regulatory authority of Germany attested
by Embassy of Pakistan, Germany.
(iv) Free Sale Certificate (original) from the regulatory authority of Vietnam.
(v) Declaration by the manufacturer regarding change of production site.
(vi) Description of manufacturing site attested by Embassy of Pakistan, Vietnam,
(vii) Copy of Quality Management System certificate i.e. ISO.13485.
(viii) Original authorization letter.
(ix) Declaration of conformity for aforementioned products issued by the principal
manufacturer.
(x) Copy of Drug Sale License.
Decision: The Registration Board approved the transfer of manufacturing site of above
mentioned products from M/s B.Braun Melsungen AG Carl-Braun-Strabe 1,
34212 Melsungen, Germany to M/s B.Braun Veitnam Co., Ltd, Thanh Oai
Industrial Complex, Thanh Oai District, 156800 Hanoi, Vietnam subject to
inspection of manufacturer abroad as per prevailing inspection policy.
_________________________________________________________
X X
Secretary Chairman
Registration Board, DRAP Registration Board, DRAP
Digitally signed by Secretary
Secretary
DN: cn=Secretary, o=DRAP,
ou=PER,
email=obaiddr@yahoo.com, c=PK
268
Date: 2014.09.01 11:02:16 +05'00'

Minutes of 244th Meeting of Registration Board

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Minutes of 244th Meeting of Registration Board

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Minutes for 244th Meeting of Registration Board held on 22-

23rd July, 2014.

Item No.I Confirmation of minutes of 243rdmeeting Registration Board 04

Item No.VI Miscellaneous Cases 178-208

Item No.VII Biological Drugs 208- 242

Item No.VIII Quality Control cases 242-258

Item No.IX Medical Devices 258-268

1. Lt General (R) Karamat Ahmed Karamat. Member

A. Dr. Amanullah Khan (Director DTL, Quetta):

B. Mr. Abdul Razzaq (Director DTL, Karachi):

S. No. Name of Drug(s) with composition Pack Demanded Decision of the

2. Theramin-T 20s Rs. 90.00 -do-

3. Theramin- S 20s Rs. 130.00 -do-

4. Theramin Fort 30s Rs. 170.00 -do-

Potassium as (Sulphate)................ 5mg.

iii. The applications complete in all respect would be given consideration.

1.2 In general, the combination products of multivitamins and micronutrients will be

1.4 This policy on food supplements lays down provisions which:

3 Vitamin and mineral preparations can be divided into two categories

5 Vitamins could be classified in to:

Electrolytes and minerals

The board after discussion approved following policy.

PROPOSED RECOMMENDATIONS FOR MINISTRY OF HEALTH

3 Vitamin and mineral preparations will be divided into two categories

8 Combination of vitamins with analgesic or antibiotics will not be allowed except

Item No.IV: Approval of Clinical Trial effectiveness of Antibiotic prophylaxis during

The outcome of the trial will be:

S# Name of Experts Comments of Experts

Decision: Registration Board approved the above clinical trial.

Case No.01. Registration of Sofosbuvir containing medicines.

The registration applications for the drug (Sofosbuvir / Sovaldi) be processed

Accordingly, the registration applications of Sofosbuvir, received by the Pharmaceutical

a) Expert opinion by:

b. An undertaking to submit Patient information

Inspection of the firm was conducted on 11-

Inspection of the firm was conducted on 27-12-

f. Specifications of API are required.

Inspection of the firm was conducted on 27-02-14

15. M/s Genix Sofo Tablets Form 5D An undertaking regarding the

16. M/s Everest Sovir Tablets Form-5 a. Evidence of renewal of

m. Clinical data (along

n. You have submitted that

u. Last / latest inspection

v. CD of the dossier alongwith

w. Before marketing of the

18. -do- Liversof 400mg/90mg Form 5-D New application

b. SOPs / procedure to record

e. Details of Reference standard

f. List of specific equipments /

i. You have submitted that raw

g. You have submitted that raw

i. Complete dissolution testing

j. Assay method under finished

k. Patient information leaflet

l. Clinical data (along with data

m. Stability studies, process

n. Complete details of HVAC

o. Specifications of water used

p. Packaging material/ container

t. CD of the dossier alongwith

u. Before marketing of the

19. -do- Livbuvir400mg/60mg Form 5-D New application

b. SOPs / procedure to record

g. List of specific equipments /