Being on the threshold of a new patents regime in accordance with TRIPS mandate, India is busy preparing the final draft of the amendments to its Patent Law and to get it passed through a Special Ordinance in few days. Though the corporate India is still divided on the merits and demerits of TRIPS and its implications in the industrial and social economy, the Indian Drug Manufacturers Association (IDMA) that represents the country's great majority of pharma industry mainly the small and medium sector, is concerned much about a possible monopolistic situation in the healthcare business. Unless the government go cautiously on such situations while meeting the WTO commitments, the country's currently vibrant drug sector would perish and ultimately the public will suffer in an unaffordable healthcare scenario, says Yogin Majmudar, President, IDMA, cautions in an exclusive interview with CH Unnikrishnan of Chronicle Pharmabiz. Excerpts:

From the first day of January 2005, India is committed to TRIPS specific product patent regime in pharma industry. IDMA as the largest representative body of the country's pharma sector, how does the Association look at the industry scenario post 2005?

With the TRIPS provision in the Patent Act, the country is going to witness reversal of the Long standing Government Policy of last 35 years on Patents. It is fact that the Indian pharmaceutical industry could manufacture even the latest drugs at very competitive prices in the shortest possible time for both domestic and international markets. Apart from making a significant contribution towards keeping medicine prices lowest in the world for the Indian consumers, the country could take pride that with the supply of low priced APIs from India, international generic medicine prices have also managed to remain comparatively low.

However, adopting the product patent regime in the pharmaceutical sector, we are likely to loose this advantage to some extent, as the freedom to manufacture the latest blockbuster drugs will be drastically curtailed. In order to ensure that the impact is minimal for the needy patients and the domestic manufacturers, IDMA during the last year has had a series of interactions with powers-to-be at all levels of the Government. We had a number of meetings with Ministers and Secretaries of various concerned Ministries and many other Government officials to put across IDMA point of view that the TRIPS regime should not lead to monopoly in the industry and it should not create panic among the public.

What are the suggestions IDMA has put forward to the government for an ideal situation in the new patent regime?

We have been advocating a balanced patent regime, which would on one hand reward genuine innovators and at the same time, minimizes public damage from monopolies. This is possible by way of adequate legal remedies viz., pre and post grant opposition to ensure that only NCEs are granted Product Patent, definition of Patentability being very precise and unambiguous to ensure that 'me-too' drugs do not get Patent protection etc. etc.

Similarly unrestricted use of Compulsory License provisions as advocated by Doha Declaration, particularly for export to 49 LDCs and other developing countries will also go a long way in ensuring continued availability of low cost medicines to our people as also to those needy across the world. Only last month the Brazilian Government of World AIDS Day announced that, to prevent the financial collapse of its successful public health programme of providing free antiretroviral drugs to HIV/AIDS infected persons would break the patent of several medications. As the Brazilian law permits the government to disregard patents in case of health emergencies such as the HIV/AIDS epidemic, antiretroviral drugs will no longer enjoy patent.

Recently, 42 NGOs from across the world have sent communication to our Prime Minister with copies to union commerce minister and health minister, expressing their concern and strongly urging to make full use of our rights under the TRIPS Agreement. Do the concerns expressed in these communications echoes IDMA's?

Yes very much. As reaffirmed by the Doha Declaration, in order to prioritize public health and access to medicines for all-over excessive monopoly rights for pharmaceutical companies, there were similar communications reached the prime minister from many international organizations including OXFAM. Our concern on this vital issue, which is likely to have far reaching consequences for the Indian pharma industry, is not limited to the progress of the industry but on the public welfare as well. We must not forget the fact that India has two levels of development in the society - one mostly urban, which is almost on par with the developed countries and the other comprising of impoverished masses. In order to enhance the country's image internationally by projecting only the brighter side and the R&D capabilities of a handful of our front-line progressive companies, we just cannot wish away the reality. It is the duty of our government to frame national policies so that they protect interests of all sections of the society.

Considering the number of patent applications in the mailbox mainly by the multinational companies, it is imperative that many of the newer molecules already launched in India but supposed to be within the patent fold, may have to be withdrawn by local companies. What would be your suggestion to get away with this heavy loss and embarrassment?

Referring to the fate of products for which patents have been granted internationally between 1995 and 2005, it is our considered opinion that in view of the transition period of 10 years granted to India up to 2005, Product Patents should be considered in India only for those applications, which are filed after 1.1.2005. Thus, none of the products patented internationally up to 1.1.2005 should qualify for product patent in India.