Government evaluating ''data exclusivity'' demand of pharma companies

17 Sep 2005

New Delhi: The industry ministry, which had earlier rejected the multinational drug companies' demand for "data exclusivity," is now saying that it was studying various options to meet the demand.

"For India, to turn into an R&D hub, we need protection of data in addition to patent cover," said Ajay K Dua, secretary, department of industrial policy and promotion (DIPP), addressing a workshop for implementation of intellectual property rights (IPR) regime on Friday. The pharma MNCs have been pitching for data exclusivity — protection from third party reliance on the data on new drugs submitted by them before the regulators for "unfair commercial use."

Currently, a committee headed by secretary, department of chemicals and petrochemocals is examining the issue that has created a seemingly unbridgeable divide between the local drug companies and the MNCs.

Usually, under data exclusivity, a pharma company enjoys monopoly on manufacturing and marketing a registered drug for anywhere between five and ten years. Local pharma industry argues that data exclusivity is a ploy by MNCs to extend the period of patent rights on drugs.

The secretary said government was also preparing a list of resource personnel on patents.

The country's patent examiners would ensure that an innovation is original before granting a patent. He said India had sought for collaborations with countries including Japan and the US to impart training to its patent examiners.