‘ign | Dr. B. S.

KUCHEKAR

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 ie,
TEXT BOOK OF

PHARMACEUTICAL
JURISPRUDENCE
SECOND YEAR DIPLOMA IN PHARMACY

(As Per E.R. 1991)

DR. B. S. KUCHEKAR
M. Pharm., Ph.D., F.I.C., LL.B.
Principal and Professor of Pharmaceutical Chemistry
Maharashtra Institute of Pharmacy
M.1.T. Campus, Paud Road, Kothrud.
PUNE 411 038.

Price ~ 120.00

NIR
PRAK
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ASHA N
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Pharmaceutical Jurisprudence ISBN 978-81-48579-02-2
Twenty Eighth Edition : July 2017
1© : Author <a
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 SYLLABUS

Origin and Nature of Pharmaceutical Legislation in India, its Scope and Objectives.
Evolution of the "Concept of Pharmacy" as an integral part of the Health care system.
Principles and significance of Professional Ethics, Critical study of the Code of
Pharmaceutical Ethics drafted by Pharmacy Council of India.
Pharmacy Act, 1948 : The General study of the Pharmacy Act with special reference to
Education Regulation, working of State and Central Councils, Constitution of these
councils and functions. Registration procedures under the Act.

The Drugs and Cosmetics Act, 1940 — General study of the Drugs and Cosmetics Act
and the Rules thereunder. Definitions and salient features related to Retail and _
Wholesale Distribution of Drugs. The powers of Inspectors, the sampling procedures
and the procedure and formalities in obtaining licences under the rule. Facilities to be
provided for running a Pharmacy effectively. General study of the schedules with
special reference to schedules C, CI, F, G, J, H, P and X and salient features of labelling
and storage conditions of drugs.
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 — General
study of the Act, Objectives, special reference to be laid on Advertisements, Magic
remedies and objectionable and permitted advertisements — diseases which cannot be
claimed to be cured.
Narcotic Drugs and Psychotropic Substances Act, 1985 — A brief study of the act with
special reference to its objectives, offences and punishments.
Brief introduction to the study of the following acts.
(i) Latest Drugs (Price Control) Order in force.
(ii) Poisons Act 1919 (as amended to date).

(iti) Medicinal and Toilet Preparations (Excise Duties) Act, 1955 (as ammended to
date).
(iv) Medical Termination of Pregnancy Act, 1971. (As amended to date).
KK

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 Chapter 1

ema
PHARMACEUTICAL LEGISLATION IN INDIA
PHARMACEUTICAL LEGISLATION
Law intends to regulate and control various aspects of social life. The aspects may be
classified as social, economical and political legislation. The Pharmaceutical Legislation is
such a mixed legislation, which overlappingly covers both social and economic aspects of the
society.
The purpose of Pharmaceutical Legislation is to ensure that the patients receive
drugs of
required quality, tested and evaluated for safety as well as efficacy for their
intended use. It
means that Pharmaceutical Legislation is associated with the health of the society.
ORIGIN
For the first time in India, a chemists; shop was opened in about 1811 by Mr. Bathgate
,
who came to India with East India Company in Calcutta. After one hundred years
(i.e. in 1910), this firm started manufacture of tinctures and spirits.
Another firm Smith Stanistreet and Co. started apothecary shop in 1821 and commen
ced
the manufacturing in 1918. Bengal Chemical and Pharmaceutical works, a small
factory was
started in Calcutta in 1901, by Acharya Prafulla Chandra Ray. In 1903, under the
leadership
of Prof. T. K. Gajjar, a small factory at Parel was started, which led to the develop
ment of
other pharmaceutical units, the Alembic Chemical Works Ltd. at Baroda.
These units were not sufficient to fulfil the requirements of Indian public. In those days
most of the medicines were being imported from abroad mainly from U.K, France and
Germany.
Then the situation was changed with the First World War. Cheaper drugs were imported
from abroad. There were also increasing demands for indigenous drugs. The Indian and
Foreign concerns entered in competition with imported medicines producing cheaper drugs.
As a result, unhealthy competition grew up and the Indian market got flooded with inferior,
substandard and even harmful drugs.
With this issue, the public made the Government to take notice of such situation of drug
trade and industry and to think of introducing effective legislation to control the import,
manufacture, distribution and sale of drugs.

In those days Opium Act, 1878, Poisons Act, 1919, and Dangerous Drugs Act, 1930 were
in existence. But these acts were not comprehensive enough to control
the prevailing chaotic
and regret table condition.
Thus, as such there was no legal control on Pharmacy profes
sion at the beginning of this
century. With rapid expansion in pharmaceutical industries and market more compr ehensive
legislation was required. Hence, to have a comprehensive legislation, the Indian Government
(1.1)

Danses en 2

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S.Y, Diploma Pharmaceutical Jurisprudence +2 Pharmaceutical Legislation in India

appointed a ‘Drug Enquiry Committee' ; u nder the Ch i ;

1931 (D. E. C. or Chopra Committee), priser taseneh see
oe a. was asked to make enquiries in the said matter and then to make
reco! mendations for smooth control of manufacture, import, distribution and sale of drugs in
the interest of public health.
Recommendations of Drug Enquiry Committee :
The committee submitted a comprehensive report with about 90 recommendations.
The main recommendations are as follows :
(1) The committee recommended the formation of Central Pharmacy Council and the
n and
Provincial (state) Pharmacy Councils which would look after the educatio
ng the
training of professionals. These councils would maintain the register containi
names and addresses of the Registered Pharmacists.
suggested the creation of
(2) In the recommendations, the Drugs Enquiry Committee
branches in all the states.
drug control machinery (Departments) at the centre with
of a well-equipped Central
(3) The committee also recommended the establishment
experts for an efficient and speedy
Drug Laboratory (CDL) with competent Staff and small
sted that the
of Drug Control Department. It was also sugge
working
laboratories w ould work under the guida
nce of Central Drug Laboratory.
there was de lay in introduction of legislation
as per
Due to Second World War in 1939, by
Committee, which was considered as an urgent
the recommendations of Drugs Enquiry
Indian Government.
of DEC, the
the Gove rnme nt, reluc tant to implement the recommendations
Finding the said recommendations.
pressure from the publi c was increased to implement to
in 1937 in Legislative Assembly,
demand and
Bill was introduced
Ultimately, an Import of Drugs Committee. The
of drugs. The Gove rnme nt preferred to refer the Bill to Select sale of
control import and the question of manufacture and
impo rt of drugs
Bill was limited only to the Comm itte e pressed for comprehensive
legislation
Hence, the Selec t
drugs was left untouched. to control and regulate manufacture,
sale and
impo rts but also
not only to control
country.
distribution of drugs in the vf “
SCOPE AND OBJECTIVES
194 0 in the Legisl ative Assembly. Aftér considering the
The Drug Bill was intr
oduced in
into force as Drug Act 1940
l 1940 was passed. It came
e, Drug Bil
report of Select Committe Dr ug Act has bee n ammended many times an
d
7. Since the n the
after seven years i.e. in 194 ate d to Drugs, Cosmetics,
Ayurvedic, —
the pro vision s rel
at present the Act covers ug s and Cosmeticsics Act is an improve
icines. The pre sen t Dr
nani l thic i medici Act is to regulate the import,
ma ini obj ect
j of thi s
eversioi n g i
ove na
r athe Drug Act, 1940. The ic s. The Central Government
has
Dr ug s and Co sm et
ion and sale of of drugs and cosmetics 1n
manufacture, distribut e, distribution and sale
for the manufactur d
made a number of Rules Rules 1945'. These act and rules are ammende
Cosmetics
India entitled "The Drugs and
from time to time.

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 S.Y. Diploma Pharmaceutical Jurisprudence 1.3 —____________Pharmaceutical Legislation in nei
—

With the achievement of Independence in 1947, the rest of the required enactments we
®

also passed following the recommendati i

ons of DEC.
)

The Pharmacy Act, 1948 was passed with the object to regulate the profession of

|
Pharmacy in India.

Ia 1954, 'The Drugs and Magic Remedies (Objectionable Advertisements) Act' was passed
with the main aim to control certain types of advertisements related to drugs and to prohibit
certain kinds of advertisements related to magic remedies.
The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 was passed providing for
the levy and collection of duties of excise on medicinal and toilet preparations containing
alcohol, opium, Indian hemp or other narcotic drugs and narcotics. The Central Government
has framed certain Rules under the provisions of this Act, called as ‘The Medicinal and Toilet
Preparations (Excise Duty) Rules 1956’.
Under the essential commodities Act, 1955, and in supersession of the Drugs (Prices
Control) Order 1979, the Central Government made the Drugs (Prices Control) Order 1987.
In 1985, the ‘Narcotic Drugs and Psychotropic Substances Act, was passed along with the
Rules repealing the Dangerous Drugs Act, 1930 and Opium Act, 1878. The main object of this
act is to consolidate and amend the law relating to Narcotic Drugs and to make stringent
provisions for the control and regulations of operations relating to Narcotic Drugs and
Psychotropic Substances and for the matters connected therewith. The Prevention of Illicit
Traffic in Narcotic Drugs and Psychotropic Substances, Ordinance, 1988 is supplemented to
this act.
There are also some other enactments,which are directly or indirectly related to
manufacture, distribution and sale of Drugs and Pharmaceuticals in India. These are :
(1) Prevention of Food Adulteration Act, 1954 and Rules
(2) The Industries (Development and Regulations) Act, 1951
(3) The Industrial Employment (Standing Order) Act, 1946 and rules
(4) Industrial Dispute Act, 1947
(5) Factory Act, 1948
(6) The Indian Patent and Design Act 1970
(7) The Trade and Merchandise Mark Act, 1958
(8) The Epidemic Diseases Act, 1897
(9) Shops and Esteblishments Acis of respective states
* kK *

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 Chapter 2

PHARMACY AND HEALTH CARE SYSTEM

The interdependence between Pharmacy and Medicine runs back through countless ages.
During Vedic times, medical treatment was associated with religious services in India. Hindu
Medicines (Ayurvedic medicines), begin with the 'Atharva Veda' which contains a list of
diseases with their symptoms in the form of incantation. Ayurveda, the science of longevity is
appended to Atharva Veda. In Rig - Veda many medicinal herbs are described and water is
prescribed as the best cure of most diseases. In Vedic times, the physicians and surgeons
lived in Garden Houses and cultivated the required medicinal plants.
There were no separate professions of Medicine and Pharmacy. A Physician prepared his
own medicines. Sometimes the family members of patients also were asked to prepare the
remedies from medicinal plants.
Sushruta and Charaka are the two great names in Ayurveda. Charaka composed a book
of information on Ayurvedic medicines called as 'Charaka Samhita‘ which is still used in
India.
When Muslim came and ruled India, they brought their Unani system of medicine. With
the change in the pattern of society, both the systems, Ayurvedic and Unani showed
considerable changes.
During the 18th century the systems of medicines were advanced with the time and came
into existence the organization of Hospital. Since, then the hospital organization is working
with the aim of attaining, maintaining and promoting the health of the nation, where the
services of different health professionals are utilised. The health professionals such as
clinical practitioner, nurses, technicians, medical social workers, dieticians and pharmacists
etc. are together referred as Health Care Team.
The, Allopathic system of medicine was introduced by the British when they ruled India.
In those days pharmacy education was started in India to train the professionals. Some
pharmaceutical associations were also formed. The tendency to specialization has affected
the separation of Pharmacy from Medicine with little overlapping of jurisdiction and practice.
Then the function of physician is to diagnose disease and to recommend the treatment
through prescription, while pharmacist has to dispense the medicines according to the
prescriptions.
During the last 5 to 6 decades, complex and potent organic compounds are introduced as
medicines. Being potent, these are to be administered with great care and in standardized
dosage forms like tablets, capsules and injections etc. Such complex and potent dosage forms
can not be dispensed or prepared in very small scale maintaining their strength and stability
each time. They are to be manufactured in pharmaceutical industries with subsequent
quality control.

(2.1)

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 2.2 Pharmacy and Health Care System
' Diploma Pharmaceutical Jurisprudence
technology, as well as in the potent of
With the developing trend in the science and rmation to the
the info
athetic drugs, pharmacists responsibility is increased to give
ts etc. of such drugs in the interest of
escriber and the patients regarding the use, side effec
ty of the products which
e public health. Pharmacist is legally held responsible for the quali on activity
res that the distributi
distributes. Because of such responsibility the Law requi
all drugs be restricted to the pharmacist.
Conference in 1963 a pharmacist is
As per the discussions held at British Pharmaceutical osis and
garded as an expert on drugs while a medical practioner is concerned with diagn
whole range of drugs. Accordingly, the
A pharmacist has to deal with the
eatment.
knowledge about the drugs.
,armacy education is so framed that he gets all
as a dispenser or compounder. The
Now-a-days pharmacist is no longer regarded are
in clinical pharmacy. So, many changes
spensing pharmacy is gradually emerging t
macy. Pharmacist has to play an importan
quired to be made in the concept of Phar t
be responsible for planning and establishmen
nsultative and management role. He should
‘proper pharmacy services.
the changes such as economical, political and
Health care system is highly influenced by to
in the practice of pharmacy will continue
chnological changes. Evolutionary changes
ave an impact on changing health care system.
ional
are outlined in the report of the Internat
Some important aspects of health care ‘Health
in Sept. 1978 at Alma Ata to achieve the goal
onference on primary health care held
r all by 2000 A D. They are : g,
he alth problems and the methods of identifyin
(1) Education concerning prevailing
preventing and controlling them.
proper nutrition.
(2) Promotion of food supply and
locally epidemic diseases.
(3) Prevention and control of
(4) Provision of essential drugs.
diseases.
(5) Appropriate treatment of common
infections and diseases.
(6) Immunisation against the major
professionals.
(7) Availability of health
Policy.
(8) National Health Care lemented
as the basic requirement to be supp
Moreover, this report was regarded its public.
ng to the economic and soc ial values of the nation and
scordi
A.D.", necessary supporting pharmaceutical
To achieve the goal, "Health for all by 2000
d, which is possible only when pharmacy
wvices are required to be extended and organise of health care
an important member
‘timately and the pharmacist has been accepted as
sam.
presently consists of :
The profession of pharmacy in our country
(1) Academic Pharmacists
(2) Industrial Pharmacist
(3) Hospital Pharmacist
(4) Community Pharmacists

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 Chapter 3

PHARMACEUTICAL ETHICS

ETHICS AND LAW

efully
ence of moral duty. A code of ethics is a car
Ethics means moral principles. It is a sci r group of
of practice for the guidance of a particula
formulated system of principles or rules e of Eth ics is an
individuals, such as the members of a profession. The development of Cod
moral consciousness.
indication of the evolution and growth of
Law is defined as ‘Rules of human conduct
There is a difference between Law and Ethics. h a
While Ethics is defined as ‘Rules by whic
hinding all persons in a state or nation'.
all its members.
profession regulates actions and sets standards for
the method of enforcing compliance with the
The major difference between the two is in
cted to punishment, a fine or imprisonment
rules. If a law is broken, a violator may be subje
derable monetary penalties in a civil action.
or both or the violator may be subjected to consi
n, the professional body may subject the
If rules of ethics (professional conduct) are broke
professional ethics often set standards of
violator to loss of professional previleges. Codes of
éonduct which differ from the standards of law.
er, but it can't force him to help his
Law may prevent one from causing injury to anoth
is the function of ethics.
neighbour in hours of need. Helping the neighbour
a pharmacist from selling drugs of
_ Drugs and Cosmetic Act and Rules prevent
g the drugs at a cheaper rate than that of
substandard qualities but can't prevent from sellin
l. Such unhealthy tendancies which are
his fellow pharmacist in his area which is not ethica
ethics. Ethically, a pharmacist can't
not within the purview of Law can be settled with code of ethics is an
said that a man without
be incharge of a medical store when he is drunk. It is
uncivilised man in a civilised situation.
PHARMACEUTICAL CODE OF ETHICS
competent in their profession. So he
Students in professional education must become
. Every professional practitioner
must be able to place his skills within the context of society
sional competence and ethical
needs social understanding to do his work well, Profes
Professions would be lost without
behaviour are necessary for practice of any profession.
their ethical codes.
acy field to be sure that the
Therefore, it is the duty of all those involved in pharm
conduct (code of ethics) and
pharmacist in training knows the standards of professional
ain the status of pharmacy
understands that deviation from those standards can not maint
profession. Pharmacy being a profession, requires knowledge, skill and integrity on the part
sion in the responsible
of those engaged in it. This profession is associated with medical profes
nsing the useful and some
duties of preserving the public health. Also, it deals with dispe
times useful and dangerous agents to cure the disease. Therefore, the members of pharmacy
(3.1) —

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 3.2 Pharmaceutical Ethics
S.¥. Diploma Pharmaceutical Jurisprudence
i d el in their several
ession i shoul
pane on id unite on some general principles to be observed
aa em other, to medical profession and public. Professional ethics for
to the |
service. |
P y cessary in the public interest to ensure an efficient pharmaceutical
Pharmacy Council of India has formulated the code of ethics for the guidance of |
pharmacists. Such code of ethics covers the rules or the principles to be observed by the |
pharmacist while dealing himself with his job, his patrons and the public, his fellow
pharmacists and the member of medical and other health profession.
PROFESSIONAL CONDUCT
in the public
Standards of professional conduct for pharmacy profession are necessary
interest 3 ensure an efficient pharmaceutical service. In addition to give such service, the
pharmacist should also avoid any objectionable acts or omissions. The pharmacist should
maintain good social career and have an attitude of service and sacrifice in the interests of
the suffering humanity.
poisons
In handling, selling, distributing and dispensing of medical substances, including
is responsible
and potent drugs, a pharmacist along with the members of medical profession
for safeguarding the health of the public.
s with information or
The pharmacist should at all times be ready to assist colleague
advice.
fulfil professional obligations
The pharmacist should recognise their responsibilities and
honourably and with due regard for the welfare of the society.
PHARMACIST IN RELATION TO HIS JOB
Pharmaceutical Services : e
A pharmacist sho uld provide an efficient and reasonably comprehensiv
1.
cal store or pharmacy.
pharmaceutical services through the medi
required medicines without undue delay
2. Such services include supply of commonly
at all times.
and furnishing the emergency supply
Pharmacy/Drug Store : st to have
In ever y pha rma cy/ dru g store, there should be a qualified pharmaci
3. onsible
arily resp
cy. The pharmacist shall be prim
personal control over the pharma with it.
for the observance of properstandards of conduct in connection
no accidental
rma cy sho uld be pla nne d in such a way that there is
4. A pha nes.
tio n in the pre par ati on, dispensing and supply of medici
contam ina of
character
of the preé mises should reflect the professional
5. The appearance rmacy 1s the main
and ind ica te to the public that the practice of pha
pharmacy
ment.
purpose of the establish
¢
Prescriptions : or
be discussed with patients
should not
Prescriptions presented for dispensing
6. iciency.
demerits of their therapeutic eff
others regarding the merits and ression
g the pres crip tion s, a pha rma cis t should not even show any exp
7. After receivin ers.
faith in the physicians or prescrib
on his face so that the patients will los e their

—————

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 3.3 Pharmaceutical Ethics
SY. Diploma Pharmaceutical Jurisprudence _
iption should be
8. No addition, omission, or substitution of ingredients in a prescr
made without the consent of prescriber or physician whenever possible except in an
emergency.
the
9. In case of any obvious error in the prescription, it should be referred back to
prescriber for necessary correction or approval of the change suggested.
10. If at all the change in the prescription is necessary in the interest of the health of
the patient, it should not affect the reputation of the physician or the prescriber.
11. A pharmacist should not recommend any particular prescriber, unless he is specially
asked to do so.
Drugs/Ingredients :
12. While dispensing the prescription, the ingredients or drugs must be weighed or
measured correctly as the case may be by scales or measures.
13. Pharmacist should always use drugs and medicinal preparations of standard
quality.
14. Drugs or medicine likely to cause addiction or other form of abuse should not be
supplied when there is reason to suppose that it is required for such purpose.
Practical Training :
15.While imparting practical training the incharge pharmacist should see that the
trainees acquire sufficient technique and skill.
16. No certificate should be granted to the trainee pharmacist before completion of
prescribed period for training or without undergoing practical training or unless the
trainee acquires sufficient knowledge.
PHARMACIST IN RELATION TO HIS TRADE
Price structure :
Prices of drugs and medicinal preparations charged from the customers should be
1.
fair and including dispensing and compounding charges without unduly taxing the
purchaser.
Fair Trade Practice :
2. A pharmacist should not make any attempt to capture the business of fellow
pharmacist by unhealthy competition or cut-throat competitions, that is by offering
reduced price, gifts, prizes, etc.
3. Trade marks, labels, symbols or any other signs of other pharmacists should not be
copied or imitated.
4. Drugs or other ingredients required, should always be purchased from reputable
_ sources.
Hawking of drugs and other :
5. Hawking of drugs and medicines should not be practised and any attempt should not
be made to collect the orders from door to door.
6. Self servicing method in the pharmacy or drug stores should not be allowed as it
would encourage self medication which is undesirable and dangerous.

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SY. Diploma Pharmaceutical Jurisprudence 3.4 Pharmaceutical Ethics
Advertisement and Display :
=
ay.
There should not be any display or advertisement on the premises, in the news
paper or elsewhere regarding the abilities and services provided by the pharmacy.
The pharmacist should not make such advertisements which contain :
(i) Misleading or exaggerated statements or claims.
(ii) A guarantee of therapeutic efficacy.
(iii) An offer to refund money paid.
(iv) An appeal to fear.
(v) The word 'cure' in reference to an ailment or symptoms of ill-health.
PHARMACIST IN RELATION TO MEDICAL PROFESSION
a A pharmacist, under no circumstances, should practice medicine, that is diagnosing
diseases and prescribing medicines. However, in case of accidents or emergencies, he
may render first aid services. ;
A pharmacist should not recommend any particular medical practitioner, unless
specially asked for.
Pharmacist should never enter into any secrete agreements with the medical
profession, physicians, dentist, veterinary surgeons to offer them commission or gifts
by recommending his dispensary or drug store.
Pharmacist should not have any clandestine or underhand arrangement with
any physician.
Pharmacist is a link between medical profession and public. He should be constantly
in touch with modern development in pharmacy and allied fields. He should be
expert in the field of pharmacy so that he may advice the physicians on
pharmaceutical matters. By enlarging his store of knowledge he may be able to
educate the public to maintain their health.
with customers nor
5. Pharmacists should neither discuss physician's prescriptions
disclose to them the composition of prescriptions.
ON
PHARMACIST IN RELATION TO HIS PROFESSI
iples to maintain the standard
1. A pharmacist should observe the law and ethical princ
of the profession.
to his fellow pharmacist in an
2. A pharmacist should extend the help and co-operation
emergency and legitimate n ;
conduct of
ble corrupt or dishonest
A pharmacist should try to weed out the undesira
status in society.
the member of his profession maintaining its
e of laws of the state and nation
A pharmacist should have a fair knowledg :
ation, health ete.
pertaining to food, drug, pharmacy educ
knowledge of professional matters. “He
A pharmacist should have an upto date nizations, the aims and
pharmaceutical orga
should associate himself with various | .
this code of ethics.
objects of which are compa tible with discredit to his
acts which will bring
A pharmacist should not perform such
profession or to himself.
2K kK XK

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 >,
Chapter 4

PHARMACY ACT, 1948

INTRODUCTION AND OBJECT

Before Independence, there were no regulations for the profession and practice of
Pharmacy. Drug Enquiry Committee recommended that the persons practicing Pharmacy i.e.
the persons responsible for compounding and dispensing of medicines should have a proper
educational background. Health Survey and Development Committee also made similar type
of recommendations, consequently the Pharmacy Act came into force in March 1948.
The Pharmacy Act, 1948 is passed with the main object to regulate the profession and
practice of Pharmacy and to raise the status of profession of pharmacy in India. To achieve
this object, the Act provides for the constitution of Pharmacy Council of India, (Centra
Council) which is responsible for evolving educational standards and regulations for the
Diploma Course in Pharmacy through Education Regulations. The Act, in addition to Centra
Council, provides for the constitution of State Pharmacy Councils for the registration o
Pharmacists and for regulating their professional activities.

DEFINITIONS
1. Central Council : The Pharmacy Council of India.
2. Central Register : Register of pharmacists maintained by the Central Council.
3. Medical Practioner : Means —
(a) A person holding a qualification granted by an authority specified or notifieg
under sec. 3 of Indian Medical Degrees Act 1916, Or specified in the schedule
of the Indian Medical Council Act 1956, Or,
(b) A person registered or eligible for registration in a medical register of a stata
meant for the registration of a person practising modern scientific system o
medicine. Or,
(c) A person registered in a medical register of a state who although not fallin;
within subclause (a) or (b) is declared by a general or special order made by
state Government in this behalf as a person practicing the modern scientifi
system of medicine for the purpose of this Act, or
(d) A person who is engaged in the practice of veterinary medicine and wh
possesses qualification approved by State Government.
4. Registered Pharmacist : A person whose name for the time being is entered in the
register of pharmacists of the state, in which he is for the time being residing or
carrying on his profession or business of pharmacy.
5. Displaced Person:
(a) A person who on account of the setting up of the Dominions of India and
Pakistan or on account of the civil disturbances or the fear of such disturbances
(4.1)

A
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SY. Diploma Pharmaceutical Jurisprudence 42 Pharmacy Act, 1948
in area now forming part of Pakistan has on or after the first day of March
ne left or been displaced from his place of residence in such area and
who
as since then been residing in India,
(b) a enanais, who on account of civil disturbances or the fear of such
- hees in any area now forming part of Bangladesh, has after the
14™ day of April 1957 but before the 25th day of March 1971, left or has been
displaced from his place of residence in such area and who has since then been
residing in India.
6. Repatriate : Any person of Indian origin who on account of civil disturbances in any
area now forming part of Burma, Sri Lanka or Uganda, or any other country has
after the 148 day of April 1957, left or has been displaced from his place of
residence in such area and who has since then been residing in India.
7. University Grants Commission : It means the University Grants Commission
established under section 4 of the University Grants Commission Act, 1956.
8. Indian University : It means a University within the meaning of section 3 of the
University Grants Commission Act, 1956 and includes such other institutions, being
institutions established by or under a Central Act, as the Central Government may,
by notification in the Official Gazette’ specify in this behalf.
PHARMACY COUNCIL OF INDIA
Pharmacy Act, 1948 provides for the constitution of a Central Council (Pharmacy Council
of India) under section 3 of the chapter 1 by the Central Government. The council consists of
following members.
(a) Six members, among whom there shall be at least one teacher of each of the subjects
of Pharmaceutical Chemistry, Pharmacy, Pharmacology and Pharmacognosy elected
by the University Grants Commission, from among persons on the teaching staff of
an Indian university or a college affiliated thereto which grants degree or diploma in
pharmacy.
(b) Six members nominated by the Central Government of whom at least four shall be
possessing degree or diploma in pharmacy and practicing pharmacy or
pharmaceutical chemistry. :
(c) One member elected by the members of Medical Council of India amongst
themselves. ;
(a) A representative of UGC and representative of the All India Council for Technical
Education.
gst
(e) One member from each state elected by the members of each State Council, amon
themselves shall be a registered pharmacist. (From pharmacy amendment Act 1976,
one member nominated by Government of each union territory, instead of electing,
who shall be eligible for registration under sec. 31).
(f) One member from each state, nominated by State Government, shall be a registered
pharmacist.
Following are the ex-officio members.
(g) Director General of Health Services
(h) Drug Controller of India.
(i) Director of the Central Drugs Laboratory.

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S.Y. Diploma Pharmaceutical Jurisprudence = 85

Pharmacy Act, 1948
FUNCTIONS OF PHARMACY COUNCILOF INDIA (PCI)
The main functions of Central Council are as follows
:
1. To prescribe the minimum standard of education required for quali
fication ag a
pharmacist. (This can be provided by making
the rules as education regulations
which prescribes minimum qualification for
admission, duration of the course
details of syllabus, practical training, and exami
nation, minimum facilities required
for the conduct of course, examination and practical training).
2. To regulate the minimum educational standard. (For
this purpose, Council appoints
Inspectors to inspect the institutions providing the mini
mum standards in education
in pharmacy and report on the facilities available and decides wheth
er the institutes
should be recognised or not.
3. To recognise qualifications granted outside the territories
to which Pharmacy Act
1948 extends for the purpose of qualifying for registration
under the said Act.
4. To compile and maintain a central register for pharmacist
containing names of all
persons for the time being entered in the state register.
5. Any other function that may be assigned to the Central Council in the
furtherance of
the objectives of the Pharmacy Act, 1948. ;
President and Vice President of Central Council :
The president and vice president of the council shall be elected by the members of the
council amongst themselves. President and Vice President holds a office for a term not
exceeding five years and not extending beyond the expiry of his term, as a member of council.
But, if his term as a member of Central Council expires before the expiry of the full term for
which he is elected as President or Vice President; and if he is re-elected or re-
nominated as a member of Central Council, he can continue to hold office as President or
Vice President for the full term for which he is elected. .
Term of Office and Casual Vacancies: _
(a) Nominated or elected member shall hold office for a term of five years from the date
of nomination or election.
(b) A nominated or elected member may resign his membership at any time by writing
to president. Seat of such member thereupon remains vacant.
(c) A nominated or elected member should have to vacate his seat if he is absent
without excuse, sufficient in the opinion of the Central Council for three consecutive
meetings of the council.
(d) Causal vacancies as in above cases can be filled by, fresh nomination or election as
the case may be. The person so elected or nominated can hold office only for a
remainder of the term for which the member whose place he takes.
(e) Members of Central Council can be eligible for re-nomination or re-election.
Staff Remuneration and Allowance :
The Central Council may :
1. Appoint a registrar who may act as a secretary, and if deemed expedient, act as a
Treasurer of the council.
;
2. Appoint such other officers and servants as considered necessary 2 enable itit to

carry out its function.

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