SECRETARY, DEPARTMENT OF PHARMA,GOVT. OF INDIA INDO AFRICA BUSINESS SUMMIT AT HYDERABAD

Size: px

Start display at page:

Download "SECRETARY, DEPARTMENT OF PHARMA,GOVT. OF INDIA INDO AFRICA BUSINESS SUMMIT AT HYDERABAD"

Aubrie Small
6 years ago
Views:

1 *ADDRESS BY SHRI ASHOK KUMAR, IAS, SECRETARY, DEPARTMENT OF PHARMA,GOVT. OF INDIA INDO AFRICA BUSINESS SUMMIT AT HYDERABAD Shri Anand Sharmaji, Hon ble Minister of Commerce & Industry, Govt. of India, Prof. Mr. Peter A Nyongo, Hon ble Minister for Medical Services, Govt. of Kenya, Mr. Venkat Jasti, Chairman, Pharmexcil, Director Generals of FDA from all countries, Foreign dignitaries, my colleagues from the Commerce Department and Department of Pharmaceuticals, Government of India, ladies and gentlemen. Indian Pharmaceutical industry has performed extremely well during the period with exports of around Rs crores (approx. US$9.00 bln.). This is a year on year (YoY) growth of 21.98% (21.33% in US$ terms) compared with 8.34% during when exports are valued at Rs. 30, crores (revised) (US$7.64bn.). During last year, the sector contributed 6.1% of the country s total merchandise exports, up from 4.69% during the year of The sector ranked 5 th (for 5 years from to excepting for when it ranked 4 th ) among the 92 principal commodities only behind Petroleum & crude products, Gems & Jewellery, Transport Equipment and 1

2 Machinery & Instruments. The Indian pharmaceutical Market size of industry (excluding exports and public procurement) at retail value, as per ORG-IMS reports stood at Rs.55,454 crores. (approx. US$12.2bn.) against Rs.50,410 crores in (US$11.08bn.) growing by a healthy 10% year on year. The industry achieved this feat in the face of global financial recession and slow down in India s GDP. It may be noted that as per the revised estimates of Ministry of Statistics & Program Implementation (MOSPI), India s GDP at constant prices (at factor cost) grew at 6.7% during (compared with 9% during previous year) when manufacturing industry grew by a meager 2.4% compared with previous year s growth rate of 8.2%. During the period Apr to Feb for which data is available from DGCI&S, India continues to exports predominantly formulations (58%), followed by Bulk Drugs (40%) and Herbals. United States of America is the top export destination with a share of 18% in India s pharmaceutical exports valued at US$1.55bn. followed by Russia valued at US$0.33bn. with a share of 3.84%, Germany (US$.31bn. and 3.65%), Austria (US$0.31bn. and 3.58%) and UK (US$0.27bn. and 3.12%). 2

3 India s success in global markets and strengths in R&D capabilities can best be gauged by the number of product & API approvals received from various regulatory authorities. India, as at the end of 2008, accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 & 2008, ranks first in total Type II active Drug Master Files (DMFs) with U.S. FDA and it also received 31% of all tentative approvals. Over 30% of DMFs, ANDAs, Tentative Approvals in USA are from India. The country Ranks first in total Type II active Drug Master Files (DMFs) with U.S. FDA and received 31% of all tentative approvals. India has filed DMFs for a total of 462 molecules of the total 1,117 molecules filed with US FDA. These DMFs have been filed from a total of 169 facilities by a total 136 Indian companies. India has 793 WHO cgmp approved pharmaceutical plants, 153 EDQM (for 195 molecules out of the total 693 molecules) approved pharmaceutical manufacturing facilities among which 49 sites have CEP approvals. It has the highest number of Certificate of Suitability (CEPs) is granted to India (461 CEPs (19.78%) of the total 2,330 granted by EDQM) as at the end of

4 India has several opportunities for Indian Pharmaceutical Industry. An estimated US$103 billion of generic products are at risk of losing patents by Even at a conservative estimate of 15% opportunity this translates into US$18.4 billion opportunity for India. With around 200 companies, India's biotechnology sector is growing fast and is in the early stages of development with initial emphasis on vaccines and bio-services. IMS estimates that biotechnology products accounted for over 10 percent of global pharmaceutical sales, 20 Patents on the first generation of blockbuster biopharmaceuticals are beginning to expire. Sales of bio-generics are flourishing in the unregulated markets. Firms based in India and China could be among the successful firms to bring bio-generics to the regulated markets very soon. The global market for contract manufacturing of prescription drugs is estimated to increase from a value of $26.2 billion to $43.9 billion. India and China could potentially account for 35 percent to 40 percent of the outsourced market share for active pharmaceutical ingredients, finished dosage formulations and intermediates. India has very high skills in Phase II & Phase II Clinical trials, and has good to high skills in Preclinical trials and Phase I clinical trials. 4

5 Contract research in generic pharmaceuticals is also a significant opportunity. Established generic companies would like to outsource or buy services in formulation development, bioequivalence testing, stability studies centers, etc. Various surveys indicate that India has quite a number of resourceful firms in the field of Chemistry providing high quality output in timely schedules, allowing more leads to pursue. India is significantly ahead in chemistry services such as analog preparation, analytical chemistry, focus library, combinatorial chemistry, structural chemistry, structural drug design, computer aided drug design, high throughput screening and assay development. There are opportunities such as Licensing deals with MNCs for New Chemical Entities and new drug delivery systems, marketing alliances for MNC products in domestic and international markets, Contract manufacturing arrangements with MNCs, Potential for developing India as a centre for international clinical trials. The country has the potential to become a niche player in global pharmaceutical R&D and possibilities for expansion of Biotechnology generics (also known as bio-similars) and Biopharmaceuticals. 5

6 It is in this context, the role of India is poised to become manufacturing hub for global pharmaceutical industry and as a supplier of affordable quality pharmaceuticals especially to third world countries. The country is increasingly becoming an important source of generic medicine in view of its rich vendor base. Indian Pharmaceutical Sector has come a long way, being almost non-existing during 1970 to a prominent provider of health care products; meeting almost 95% of country s Pharmaceutical needs. The Indian Pharma industry has been consistently charting high growth rate in the 1990s and 2000s. India is a member/signatory to TRIPS (1995), Paris Convention (1998), Convention on Bio-diversity (1994) and many others. India fulfilled the WTO commitment and our Patent s (Amendment) Act 2005 has become TRIPS compliant since 1 st January India thus joined the countries having industrialized free market economies and started with Product Patent Regime. Ladies and Gentlemen, let me inform you that the trend of patent filing in India has increased tremendously and it is understood that a total of more than 35,000, out of which more than

7 patent applications have been received from foreign applicants during the last fiscal. Ladies and gentlemen, while this is trend is reflection of a good sign for development, but I would like to inform you that we are also aware of the importance of taking steps to safeguard the sanctity of our Patent system and prevent filing and grant of frivolous unpatentable subject matters. Let me also alert all our friends from African continent that IP related issues are being used against India to create trade barriers & keep us out of race in the competition. Let me alert my friends here about the efforts made by certain vested interests in blocking the affordable Indian Generics from reaching the poorest of the poor. Examples of cross border seizures of essential drugs in the European Union especially when the drugs / APIs exported from India do have patents filed or grant either in the originating country (i.e. India) or the importing country. In one of the seizures the anti-aids drugs were being imported Clinton Foundation from India and meant for Nigeria were detained in Netherlands on the grounds of alleged patent violation. 7

8 Ladies and Gentlemen: let me elucidate with an example I have personally witnessed during our participation at CPhI exhibition at Germany. We were witness to the barge of legal practitioners literally visiting each and every Indian stall & informing them that they had displayed products that were infringing the rights of the patent holders. It was explained to them that the products displayed in the exhibition were not for sale in the country and was meant for the visitors from other countries visiting the exhibition where they were not patented. Despite the pleas from our Indian Participants the legal practitioners persisted in threatening the Indian participants in the Exhibition with penal action, arrests, legal action etc and also coercing them to compound the offence by seeking huge amount as compounding fees for them not resorting to legal action. Therefore, ladies & gentlemen, the Department of Pharmaceuticals, Government of India decided to assist the Indian participants through PHARMEXCIL in future exhibitions in providing legal assistance at all such exhibitions to legally deal with cases on the spot and support the MSME sector financially also. 8

9 Ladies & gentlemen, I am glad to inform you that Department of Pharma, Government of India by funding through Pharmexcil has also initiated IP awareness programmes to educate the MSME Sector and a series of such programme are being conducted in major cities. Being aware of the likely problems to be faced by the Pharma Industry on IP related problems especially the MSME Sector, my department through Pharmexcil started IPR cell at their Head Office at Hyderabad and one more is likely to be commissioned shortly at NIPER, Mohali at Chandigarh. Lastly, I would like to stress that the Government of India will assist the Pharmaceutical Industry in all possible manner in making India a Global player and achieve the goal of Health for all and reaching the poorest of the poor around the world. With these few words, I would not like to take much of your time and I wish you all the best in your deliberations for the next two days. Jai Hind *Shri Ashok Kumar could not attend the inaugural function/event due to flight delay and a copy is reproduced. 9

4. Pharmaceuticals Sector and Opportunity Ahead

4. Pharmaceuticals Sector and Opportunity Ahead In general, there are several reasons which justify focusing on pharmaceutical exports. The most important of these reasons is the size of the industry,