India has formally declined the United Kingdom’s demand to include a ‘data exclusivity’ provision in the recently concluded free trade agreement (FTA), reaffirming its commitment to the domestic generic pharmaceutical industry. Officials confirmed that the clause was discussed during negotiations, but the Indian side refused to accept any terms that would restrict the ability of generic manufacturers to operate.
Data exclusivity refers to the protection of clinical trial data submitted by innovator drug companies, typically preventing others—such as generic manufacturers—from relying on that data to obtain marketing approval for a specified period. Such exclusivity could delay the entry of lower-cost generic versions, even after patent expiry.
Protecting a Strategic Industry
India’s generic pharmaceutical sector, valued at approximately USD 25 billion, is a critical pillar of both the country’s healthcare ecosystem and its export economy. Around 50 per cent of the sector’s output is exported globally, supporting access to affordable medicines in both developing and developed nations.
An official involved in the talks stated that safeguarding the generic sector was a key objective in the FTA negotiations. “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.
India has previously taken similar positions in other trade discussions. A comparable data exclusivity request made by the European Free Trade Association (EFTA) was also declined during FTA negotiations concluded in March 2023.
Also read: India-UK FTA Set to Boost Key Sectors by 2030
Balancing Trade with Public Health
Several UK and Swiss-based pharma multinationals—including AstraZeneca, GSK, Novartis, and Roche—have been strong proponents of data exclusivity as a means to protect their research investments. However, experts note that such provisions often exceed the requirements under the World Trade Organization’s TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.
By rejecting data exclusivity, India has reinforced its policy stance that prioritises public health, access to medicines, and the legal rights of generic drug manufacturers over extended monopoly protections.
FTA Outcomes and Next Steps
The India-UK trade agreement, announced on May 6, includes substantial market access for both sides. It will reduce duties on British exports like Scotch whisky and premium cars while cutting tariffs on Indian exports such as garments and leather goods.
The decision to exclude data exclusivity provisions from the agreement is being seen as a major win for India’s life sciences sector and a signal that future trade pacts will need to align with the country’s broader developmental goals.
