Pharmaceutical Exports:Procedure & Practice

Pharmaceutical Exports: Current Senario

 The pharmaceutical exports from India for the first nine months of the
fiscal 2008-09 have peaked upto $1.2 billion, despite a slowdown in
overseas trade across all industries owing to recessional fears.
 Total exports in pharmaceutical products from India in December
2008 surged by 46.3 per cent to 1.01 billion dollars from 609 million
dollars in the same month of the previous fiscal, according to
Pharmaceuticals Exports Promotion Council (PHARMEXCIL) –
separate governing body to oversee pharma exports under the Ministry
of Commerce & Industry.
 The overseas sales in the first nine months of 2008-09 went up by 21
per cent to 8.44 billion dollars against 6.97 billion dollars in 2007-08.
 “Indian pharmaceutical sector has performed satisfactorily during
April-December 2008-09 by registering a growth rate of 28.1 per cent
in rupee terms and 21 per cent in dollar terms over the corresponding
period of the previous year,” PHARMEXCIL Chairman Venkat Jasti
stated in a press report.
 Continued

 In rupee terms, shipments stood at Rs 4,934 crore in

December, while during April-December 2008 it was
Rs 36,877 crore, according to Jasti.
 “In the current economic slowdown, the 21 per cent
growth in dollar terms in nine months of fiscal 2008-
09 was a good growth,” said DG Shah, secretary
general of Indian Pharmaceutical Alliance – the
conglomerate of leading Indian pharma companies.
 Indian pharma companies export their produces to
more than 150 countries across the world including the
US, Europe, South Africa, Brazil and Canada
 GMP helps boost pharmaceutical export
opportunities

 Most countries will only accept import and sale of

medicines that have been manufactured to
internationally recognized GMP.

 Governments seeking to promote their countries

export of pharmaceuticals can do so by making
GMP mandatory for all pharmaceutical production
and by training their inspectors in GMP
requirements.
 Pharma Exports-Great Time Ahead

 In recent news our Union Minister of Commerce and Industry Anand

Sharma said that the exports of drugs, pharmaceuticals and fine
chemicals for the year 2008-09 stood at Rs.39,538 crore, registering a
growth of about 29 per cent over the last year. This message from him
clearly predicts the flourishing future of Pharmaceutical sector and so
for the Pharma students opting pharma career.

 While addressing the Indo-Africa Pharma Business meet, Sharma said

"In recent times, the Indian pharmaceutical sector has emerged as one
of the major contributors to Indian exports with export earnings rising
from a negligible amount in early 1990s to Rs.29,139.57 crore by 2007-
08. The exports of drugs, pharmaceuticals and fine chemicals of India
have grown at a compounded annual growth rate of 17.8 per cent
during the five-year period 2003-04 to 2007-08."
 Continued

 The above facts and figures shown or put forward by Mr.

Sharma clearly indicate bright future of Pharma
companies. He in his speech added that in generic
medicines sector that is tablets and capsules, injectables
and infusion, oral solutions, ointments and creams,
Indian companies have established strong foundation in
most of the markets including Africa.
 Sharma also conveyed the message that several benefits
have been extended in Foreign Trade Policy to facilitate
more and more growth in Pharmaceutical exports, while
recognizing the contribution of Indian Pharmaceutical
Industry in exports
 Potential Market for Exports

 Growth in Pharma exports is due to increased ANDA

(Abbreviated New Drug Applications) approval in
U.S. markets and contribution from relatively less
regulated markets in Latin America,Australia(growth
is 20%-25%) and emerging markets in Middle East
and Africa region.

 The export potential of these markets is significant

because of lower competition and less entry barriers.
 North America

North
America
 Stepwise Procedure for export of
pharmaceutical products

Before the pharmaceutical company starts actual

export of their products to any country,it is very
important to understand the pre-requisites like:-

 Registration of the products with the respective

statatutory authority.
 Appointment of agent/representative in that
country.
 Selection of the markets for export

It is necessary to do a proper groundwork about the

markets and the countries targeted for the
export.The markets are thoroughly studied on
various aspects like political stability,socioeconomic
conditions,Government policies,business
environment,investment incentives,status of
judiciary etc.
 Continued …………

Following are some of the parameters to be

studied about the targeted market:-

 Market potential for the products to be exported.

 Registration requirements,cost of registration & period
to complete registration of each product.
 Labelling & packaging requirements(Pack
size,Language).
 Local regulatory guidelines(including those related to
IPR ) & standards practiced.
 Market distance(by sea/by air).
 Marketing costs.
 Distribution network.
 Sequence of activities in Pharmaceutical export

Following is the sequence of activities in

pharmaceutical exports:-

 Receive orders from overseas agent.

 Communicate order to the factory.
 Factory selects relevant batch and complies to special
requirements.
 Documents are passed to CHA(Custom House Agent)
 CHA prepares shipping bill and does other documentation.
 CHA books air space or shipping space & communicates the
same.
 Goods are released from foctory with relevant excise.
 Goods are handed over to CHA to airlift or to send by ship.
 List of documents to be passed on to the
CHA(Custom House Agent)

1. Invoice.
2. Packing list.
3. GR form.
4. Contract(if required).
5. Letter of credit.
6. DEPB pass book(Duty Entitlement Passbook).
7. Certificate of origin(If required).
8. Instruction for shipping bill.
 Technical Documentation

 To start with actual exports of the pharmaceuticals

there are number of prior requirement to be
completed,including the most the most important
one i.e,preparation and submission of registration
Dossiers for the products to be exported to that
country.The registration formats/requirements,costs
& period to complete the registration differ from
country to country.
 However,the following documents/certificate(s) are
required to comply with registration requirement:-
1. FDA license copy.
2. Free sale certificate.
3. WHO-GMP certificate.
4. Details of manufacturing facilities.
5. Details of Quality Control Systems.
6. Technical details about the prroduct mentioning
the following.
7. Samples of sales pack with Q.C test report.
 Export Registration Authorities in some
Countries
COUNTRY APPROVING AUTHORITY

1. Abu-Dhabi Abu-Dhabi centre for Herbal Medicine

Care.
2. Bangladesh Ministry of Health and Planning.

3. Czech and Slovak State Institute OF Drug control.

4. Burma/Myanmar Myanamar Drug Committee.

5. Eritrea Pharmacy Dept. of Ministry of Health.

6. Ethiopia Pharmacy Dept. of Ministry of Health.

7. Ghana The Registrar Pharmacy Board.

8. Kenya Pharmacy and Poisons Board.

9. Kuwait Drug Control and Registration Board.

10. Malaysia Drug Control Authority.

 COUNTRY APPROVING AUTHORITY
11. Philippines Directorate General of Pharmacy Affairs
and Drug Control.

12. South Africa Bureau of Food and Drugs.

13. Srilanka Cosmetics Devices and Drug Authority.
14. Sudan BADAR Drugs and Chemicals Co. Ltd.
15. Singapore Republic of Singapore,Ministry of Health
16. Thailand Drug Controller Division Regulatory
Authority,FDA.
17. United Kingdom Medicine and Healthcare Regulatory
Agency.
18. USA Food and Drug Administration(FDA)
19. Vietnam Ministry of Health.

20. Zambia Pharmaceutical Registration Department

 Worldwide Pharmaceutical Regulatory Agencies

1.Argentina 15.France 29.Korea

2.Australia 16.Germany 30.Latvia
3.Azerbaijan 17.Guam 31.Malaysia
4.Belgium 18.Guyana 32.Mexico
5.Brazil 19.Honkong 33.Newzeland
6.Bulgaria 20.Hungary 34.Philippines
7.Canada 21.Iceland 35.Russia
8.Chile 22.India 36.Singapore
9.China 23.Indonesia 37.South Africa
10.Costarica 24.Israel 38.Thailand
11. Denmark 25.Italy 39.UAE
12.Egypt 26.Japan 40.USA
13.Fiji 27.Jordan 41.Vietnam
14.Finland 28.Kenya 42.Zimbabwe
 Conclusion

 Recent studies on trade in drugs and pharmaceuticals have generally reported that the
Indian pharmaceutical industry is performing extremely well on the exports front.
These studies are, however, based on data which do not include all the categories of drugs
and pharmaceuticals. We have pointed out that the various data sources on drugs and
pharmaceuticals trade have not adopted a uniform definition of the term „drugs and
pharmaceuticals‟, thus resulting in diverging conclusions on the performance of the
industry on the trade–front. This paper made an attempt to rectify several errors that
have crept in the estimates on drugs and pharmaceuticals trade provided by the official
agencies and the industry associations alike. The exercise attempted here would, in our
view, help in a better understanding of the impact of the change in the policy regime in
the pharmaceutical sector. Our estimates show that there has been a decline in the
growth rate of exports of intermediates & bulk drugs and formulations, which account for
90.8% of the export of drugs and pharmaceuticals from India in 2006-07, in the post
1999-00 period, the period during which the monopoly rights of the inventor got
protected in India. Bulk drugs and other drugs and pharmaceutical products, on the
other hand, have shown an increase in the growth of exports under the new patent
regime; but they constitute only one-tenth of total drugs and pharmaceuticals exported
from India. The trends in the growth of imports are more alarming. The growth rates of
import of almost the entire drugs and pharmaceuticals (intermediates & bulk drugs, bulk
drugs and formulations accounting for 97.3% of imports) have increased in the post
1999-00 period. Formulations being the category showing highest growth in imports,
exhibit an increase in the growth of imports by 21.2 percentage points. The rates of
growth show a declining trend in the exports front and an increasing trend in the imports
front have long term adverse implications for the balance of trade in drugs and
pharmaceuticals which is already running into deficits. Thus the findings of this paper
confirm the apprehension that changes in the patent regime would adversely affect
India‟s trade in drugs and pharmaceuticals – exports will decline and imports will