India Rejects UK’s Data Exclusivity Proposal In Free Trade Agreement To Protect Generic Drug Industry
The sector plays a crucial role in India's exports, which continue to expand.
(Source: Unsplash)
India has declined the UK's request to include a 'data exclusivity' provision in the free trade agreement announced on May 6, aiming to safeguard the domestic generic drug industry, an official stated.
During negotiations, the UK proposed the inclusion of this provision in the trade pact. However, India did not accept it. "There is no risk to the Indian generic industry from this agreement. In fact, ensuring the growth of the generic drug sector is a key priority," the official emphasised.
The sector plays a crucial role in India's exports, which continue to expand.
Data exclusivity protects the technical data generated by innovator companies to demonstrate the effectiveness of their products. In pharmaceuticals, firms conduct expensive global clinical trials to establish the efficacy and safety of new medicines. Exclusive rights over this data allow innovator companies to prevent competitors from acquiring a marketing licence for lower-cost alternatives during the exclusivity period.
Previously, India also rejected a similar request from the four-nation EFTA bloc during free trade agreement negotiations. The European Free Trade Association consists of Iceland, Liechtenstein, Norway, and Switzerland. Their trade pact, signed in March 2023, is set to be implemented later this year.
The UK (home to AstraZeneca and GSK) and Switzerland (home to Novartis and Roche) are among the world's leading pharmaceutical hubs.
India's generic drug industry is estimated at about $25 billion, and the country exports 50% of its produce.
An expert said that data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights 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.
(With PTI Inputs)
