The non-governmental-organisations and public interest groups of the country have decided to protest against the chemicals and fertilizers ministry's move to push amendments in the Drugs and Cosmetics Act to introduce data exclusivity for drugs. The activists accused the government of succumbing to US pressures and thereby attempting to introduce TRIPS Plus provisions.

The activists have found allies in the Left parties and hope that any amendment to the Act that can jeopardize the capabilities of Indian generic industry to supply low cost medicines to poor will be questioned in the Parliament. The turn of events which led to the dilution of the original proposals in the Patent Amendment Act early last year can happen again, they feel.

Speaking to Pharmabiz, B K Keyla, convener, National Working Group on Patent Laws said that the whole talk about data exclusivity is unnecessary as it is not required under the TRIPS agreement. "If you are planning to give data exclusivity, it only means that you are introducing a TRIPS plus provision. Succumbing to external pressures to recommend such a piece of legislation is very dangerous, as it can extend towards other areas as well. Once you grant data exclusivity, compulsory licensing will also suffer," Keyla warns.

According to him, the actual intention behind seeking data exclusivity is market exclusivity. Once market approval is denied for a particular drug, no company would be in a position to manufacture it even if the country issues a compulsory license. He felt that government should not talk about data exclusivity but should just provide "data protection". He also wanted a provision to offer fair compensation to the innovator if the data generated by that company is used for marketing approval purposes by another generic company. "If you are preventing the generic manufacturer from using the data generated by the innovator, the company would not be able to manufacture the drug even if you issue compulsory license. Further, it is just wastage of funds to duplicate the data that has already been generated," he opined.

Sharing similar views, Dr Amit Sen Gupta, Drugs Action Forum, said that the government should have taken a clear stand to avoid the situation. "The TRIPS agreement does not seek data exclusivity. We have no valid reason to offer data exclusivity or amendment Drugs and Cosmetics Act," he said.

Medecins Sans Frontieres (MSF), a leading international aid agency, has also expressed its protest against the government move. In a plea to the Prime Minister, MSF (India) has said that if India provides exclusive rights over test data, generic competition from Indian pharmaceutical companies will be delayed even in cases where there is no patent protection for medicines. MSF also pointed to the recent recommendation of the World Health Organisation's Commission of Intellectual Property Rights, Innovation and Public Health which had specifically ruled out the necessity of data exclusivity in medicines. MSF wanted the generic competition to be kept alive for continuing the supply of low cost drugs to the entire developing world.