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 dollarsin the same month of the previous fiscal, according to PharmaceuticalsExports Promotion Council (PHARMEXCIL) – separate governingbody 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.

In rupee terms, shipments stood at Rs 4,934 crore inDecember, while during April-December 2008 it wasRs 36,877 crore, according to Jasti.Continued

“In the current economic slowdown, the 21 per centgrowth in dollar terms in nine months of fiscal 2008-09 was a good growth,” said DG Shah, secretarygeneral of Indian Pharmaceutical Alliance – theconglomerate of leading Indian pharma companies.

Indian pharma companies export their produces tomore than 150 countries across the world includingthe US, Europe, South Africa, Brazil and Canada

GMP helps boost pharmaceutical export opportunities

Most countries will only accept import and sale ofmedicines that have been manufactured tointernationally recognized GMP.

Governments seeking to promote their countriesexport of pharmaceuticals can do so by makingGMP mandatory for all pharmaceutical productionand by training their inspectors in GMPrequirements.

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 finechemicals for the year 2008-09 stood at Rs.39,538 crore, registering agrowth of about 29 per cent over the last year. This message from himclearly predicts the flourishing future of Pharmaceutical sector and sofor 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 oneof the major contributors to Indian exports with export earnings risingfrom a negligible amount in early 1990s to Rs.29,139.57 crore by

2007-08. The exports of drugs, pharmaceuticals and fine chemicals ofIndia have grown at a compounded annual growth rate of 17.8 percent during the five-year period 2003-04 to 2007-08."

The above facts and figures shown or put forward by Mr.Sharma clearly indicate bright future of Pharmacompanies. He in his speech added that in genericmedicines sector that is tablets and capsules,injectables and infusion, oral solutions, ointments andcreams, Indian companies have established strongfoundation in most of the markets including Africa.

Sharma also conveyed the message that several benefitshave been extended in Foreign Trade Policy to facilitatemore and more growth in Pharmaceutical exports,while recognizing the contribution of IndianPharmaceutical Industry in exports

Potential Market for Exports

Growth in Pharma exports is due to increased ANDA (Abbreviated New Drug Applications) approval inU.S. markets and contribution from relatively lessregulated markets in Latin America,Australia(growthis 20%-25%) and emerging markets in Middle Eastand Africa region.

The export potential of these markets is significantbecause of lower competition and less entrybarriers.

Stepwise Procedure for export of pharmaceutical products

Before the pharmaceutical company starts actualexport of their products to any country,it is veryimportant 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 themarkets and the countries targeted for the export.Themarkets are thoroughly studied on various aspects likepolitical stability,socioeconomicconditions,Government policies,businessenvironment,investment incentives,status of judiciaryetc.

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 thesame. 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 pharmaceuticalsthere are number of prior requirement to becompleted,including the most the most importantone i.e,preparation and submission of registrationDossiers for the products to be exported to thatcountry.The registrationformats/requirements,costs & period to completethe 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 thefollowing. 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 Herba

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

11. Philippines DirectorateGeneral 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 Medicineand 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 ofdrugs and pharmaceuticals. We have pointed out that the various data sources on drugsand pharmaceuticals trade have not adopted a uniform definition of the term ‘drugs andpharmaceuticals’, thus resulting in diverging conclusions on the performance of theindustry on the trade–front. This paper made an attempt to rectify several errors thathave crept in the estimates on drugs and pharmaceuticals trade provided by the officialagencies and the industry associations alike. The exercise attempted here would, in ourview, help in a better understanding of the impact of the change in the policy regime in

thepharmaceuti cal sector. Our estimates show that there has been a decline in thegrowth rate of exports of intermediates & bulk drugs and formulations, which accountfor 90.8% of theexpo rt of drugs and pharmaceuticals from India in 2006-07, in thepost 1999-00 period, the period during which the monopoly rights of the inventor gotprotected in India. Bulk drugs and other drugs andpharmace uti cal products, on theother hand, have shown an increase in the growth of exports under the new patentregime; but they constitute only one-tenth of total drugs and pharmaceuticals exportedfrom India. The trends in the growth of imports are more alarming. The growth rates ofimport of almost the entire drugs and pharmaceuticals (intermediates & bulk drugs, bulkdrugs and formulations accounting for 97.3% of imports) have increased in the post1999-00 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 ofgrowth show a declining trend in the exports front and an increasing trend in theimports 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 paperconfirm the apprehension that changes in the patent regime would adversely affectIndia’s trade in drugs and pharmaceuticals – exports will decline and imports willincrease.