The Hindu Business Line : Panel report on data exclusivity for drugs today

According to sources in the Industry and Ministry of Chemicals and Fertilisers, the Chairperson, Ms Satwant Reddy, who retires as Secretary, Dept of Chemicals and Petrochemicals on Thursday, will submit the report to the Commerce Secretary, G K Pillai.

The committee was to consider allowing for protection of undisclosed data against unfair commercial use under Article 39.3 of the TRIPS (Trade Related aspects of Intellectual Property Rights) agreement.

Introducing `data exclusivity' clauses into the Indian Drugs Cosmetics Act, 1940, will allow successful applicants five years protection, like it is done in the US.

Both multinationals such as Pfizer, and Indian companies such as Nicholas Piramal believe that it is time India adopted stronger IPR laws.

"We should not be comparing ourselves with small developing countries, but with competition in our own league. China, Japan, Israel have all implemented data protection laws, even Brazil is considering it," said Ms Swati Piramal, Director-Strategic Alliances and Communications, Nicholas Piramal.

According to the Pfizer India Managing Director, Mr Kewal Handa this is an opportunity for the country to reassure the global pharmaceutical industry of India's commitment to IPR laws, "to move from copying to innovating."

However, the Indian Pharmaceutical Alliance believes that India must not concede too much. In its letter dated March 13, the IPA had written to the Secretary, Ms Reddy, pointing out that investments of multinational companies which contributed to 21 per cent of total investment in the pharma sector during 1995-2000, have dropped to seven per cent during 2001-04. In absolute figures this is half of what they invested during 1995-2000, when India was moving to an IPR regime.

There are also concerns that data exclusivity will affect the generic industry, which will have to undergo its own expensive trials before it can launch its version. It is also likely to affect public healthcare, a significant per cent of which is dependent on cheaper generic versions, particularly for life saving medicines used in the treatment of HIV/AIDS, diabetes, and Alzheimer's.

Pfizer argues that the country has seen great growth in contract research services and facilities and drug discovery.

The volume of clinical trials in India is reported to have gone up 20-fold over the last decade, without data protection norms in place, point out those not in favour of its implementation.