India-UK FTA: No impact on Indian generic drug sector

New Delhi: India has not accepted the demand of the UK for inclusion of a ‘data exclusivity’ provision in the free trade agreement, which was announced on May 6, in a bid to protect the interests of the domestic generic drugs industry, an official said.

During the negotiations, the UK had asked to include this provision in the trade pact. “But India has not accepted that. There is no fear for the Indian generic industry from this agreement. In fact, it is our very important objective to see that the generic drug industry flourishes,” the official said.

The sector plays a key role in India’s exports, which are also growing. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine.

By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this exclusivity. Earlier, India had also rejected a similar demand from the four-nation EFTA bloc in their free trade agreement negotiations.