India has not accepted ‘data exclusivity’ demand by UK to protect generic drug firms

India has not accepted the demand of the UK for inclusion of a ‘data exclusivity’ provision in the free trade agreement, 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. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed in March 2023 and will be implemented later this year. The UK (AstraZeneca and GSK) and Switzerland (Novartis and Roche) have some of the major pharma firms of the world. India’s generic drug industry is estimated at about USD 25 billion, and the country exports 50 per cent of its produce.

An expert said that data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO (World Trade Organization).

India and the UK on May 6 announced the conclusion of the free trade agreement, which will make British Scotch whiskey and cars cheaper in India, while reducing duties on Indian imports such as garments and leather products here.