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Shri Kamal Nath, Union Minister of Commerce & Industry, has said that export of drugs from India will not in any way be affected by the amendment to the Indian Patents Act. “The global market for generic drugs is currently estimated at US $ 40 billion and the impending expiry of patents on drugs worth US $ 60 billion during the next five years offers huge opportunity to India”, the Minister said while participating in the World Economic Forum (WEF) Session in Davos (Switzerland) on “India Meets Doha” which discussed the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPs) in the context of the healthcare industry and its implications for India’s research & development (R&D) and intellectual property rights. Shri Kamal Nath reiterated that the new patents regime would not affect domestic prices as 97% of the drugs in the Indian market were already off-patent, including 350 live-saving essential drugs. “The 12 ARVs (anti retro-viral drugs) most used for AIDS and manufactured in India, cannot be patented, as they are pre-1995 inventions. India will continue to manufacture, use and export them without hindrance”, Shri Kamal Nath stated.
Underlining the possibility of India taking centre stage in drug development in the near future, Shri Kamal Nath stressed that India had a 10 billion dollar pharmaceutical industry, which was the 4th largest in terms of volume and the 13th largest in terms of value. There were 300 pharma companies in India of large and moderate size and 5500 small pharma companies, while the largest number of units approved by the US-FDA outside America were in India. Although at present less than 0.25% global spending in Pharma R&D was being done in India, Shri Kamal Nath said that “with higher patent protection, it is expected that more medical research would take place in India, given the cost advantage and large pool of technical and scientific talents in India”.
Stressing the emergence of India as a low cost centre for medical research, Shri Kamal Nath said: “India will – in fact, is already emerging – as a low cost centre for medical research. Many multinational companies from Europe and America have tied-up with local ‘Indian Multinationals’ (such as Nicolas Piramal, CIPLA, Dr. Reddy, Ranbaxy, Wockhardt) to carry out research for new molecules. India has world-class talent with requisite training. Our manufacturing and R&D Labs are well equipped. There is synergy between fields of IT, biotechnology and medicine. The cost of Basic Research and Drug Discovery in India is much lower as compared to the Western counterparts. For a new drug to come in to the market, the average cost is 810 million dollars and takes 10-15 years in the Western countries. The global Pharma industry, therefore, desperately needs strategies to bring down the cost. Therefore, outsourcing in India has become an option. While outsourcing in India provides cost-benefit to the giant pharma companies, it is also a huge opportunity for smaller international companies which do not have well developed drug discovery programmes, to get a toehold, making it a win-win strategy. The first steps into Drug Discovery have already been taken by many pharma companies in India through in-house research as well as partnership with global players. The Patent Law in India, complying as it does with international norms for intellectual property, establishes India’s credibility and enormous strength in basic research and drug discovery is not a far-fetched dream”.
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