India prioritizes generic pharma sector in UK trade talks, declines data exclusivity

India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion.
Government officials confirmed the move, stating that requests from the UK and Switzerland have been rejected for data exclusivity clauses. India is also in FTA talks with the USA, reports The Pharma Letter’s India correspondent.
"Our position on data exclusivity remains steadfast and non-negotiable, as demonstrated in the recent FTA. We have repelled attempts to introduce provisions that would have crippled our generic sector's agility," said an official.
Officials said the UK advocated strongly for the provisions, but it would have restricted Indian generic manufacturers' ability to leverage existing clinical trial data from originator companies.
India's current legal framework is a critical enabler, officials said, facilitating rapid market entry and optimising cost structures for the country's generic partners by allowing them to utilize this data for off-patent products.
Conceding to data exclusivity would have meant imposing unnecessary and costly independent data generation on Indian pharma, officials added. While this would delay the availability of affordable medical alternatives, it would also artificially prolong market monopolies for patent holders, officials said.

Will stop big pharma from blocking production
Commenting on the implications, officials noted that pharma majors like AstraZeneca (LSE: AZN), GSK (LSE: GSK), Novartis (NOVN: VX) and Roche (ROG: SIX), among other British and Swiss pharmaceutical companies, would be unable to block local production of cost-effective versions of their drugs.
This marks the second recent FTA that omits data exclusivity. Earlier, India had declined a similar data exclusivity request from the four-nation European Free Trade Association (EFTA) bloc during their FTA negotiations. The pact was signed on March 10, 2024, and is anticipated to be implemented by fall 2025, following parliamentary approval in the respective EFTA countries.