Govt: Data exclusivity report by month-end

The Chemicals and Fertilisers Ministry was likely to release its report on data exclusivity for pharmaceutical and agricultural chemicals by May 31, a government official said today.

"We will release the report for further deliberations by May 31," Joint Secretary GS Sandhu said.

While he didn't detail on the period of data exclusivity being proposed for pharma products, another official in the ministry confirmed the period at five years.

Earlier, it was reported that the government committee, chaired by Chemicals Secretary Satwant Reddy, had a consensus on granting five-year data exclusivity on agricultural chemicals.

However, the health ministry, one of the constituents of the committee, continues to have reservations on the proposal, citing health concerns for the millions of poor in the country.

There has been growing pressure on India from the developed world, particularly the US, to include data exclusivity in its Drugs and Cosmetics Act in adherence to Article 39.3 of the TRIPS agreement.

Tightrope walk: Data exclusivity provisions will prevent generic drug-making companies from using the data on safety and efficacy of original formulations to gain regulatory approval for generic versions.

Generic drugmakers claim bio-equivalence of their formulations based on the available data on a molecule before applying for approval. The drug regulatory authority refers to the available data to evaluate their application and eventually grants approval.

Data exclusivity requires generics makers to conduct expensive clinical trials all over, or simply wait for the exclusivity period "" ranging from three years to 10 years "" to get over.

The provision, if legislated, will provide a clear edge to branded drugmakers, undercutting competition from the generics industry and denying a vast mass of world population of affordable medicines, activists fear.

"Data exclusivity is nothing but a patent by a different name. Article 39.3 aims at any unfair commercial use of the data, but makes no mention of data exclusivity," Leena Menghaney, a legal expert with Medicines Sans Frontiers (MSF), said.

MSF, a non-profit organisation, sources about 85 per cent of its medicines from India to distribute them mostly in the Third World.