India declines the UK’s push for data exclusivity in FTA, keeping focus on safeguarding its $25 billion generic drug industry.
India has declined to accept the United Kingdom’s demand that it include a provision on data exclusivity in the free trade agreement concluded on May 6, aiming to protect the interests of its generic pharmaceutical industry.
A report in the Economic Times, quoting an unnamed official, said the UK had sought to include data exclusivity in the agreement. This clause would have given innovator pharmaceutical companies exclusive rights over technical data related to new drugs for a certain period. This would have effectively prevented the approval of cheaper generic versions based on that data during the exclusivity term.
“But India has not accepted that. There is no fear for the Indian generic industry from this agreement. It is our essential objective to see that the generic drug industry flourishes,” the official said. India’s $25 billion generic pharmaceutical industry exports nearly half its production, playing a vital role in its international trade.
Data exclusivity typically applies to the results of clinical trials conducted by originator companies to prove the safety and efficacy of new drugs. Such exclusivity would prevent regulators from using this data to approve similar, low-cost generic versions, even if the original drug’s patent has expired.
India had earlier rejected similar provisions during trade negotiations with the European Free Trade Association (EFTA), which includes Switzerland, Norway, Iceland, and Liechtenstein. That agreement was signed in March 2023 and is expected to be implemented later this year.
Pharmaceutical companies in the UK and Switzerland—including AstraZeneca, GSK, Novartis, and Roche—are known for seeking such protections in trade deals to safeguard their research investments. However, Indian officials argue that data exclusivity is not mandated under the World Trade Organization’s TRIPS framework, and agreeing to such terms would exceed global obligations.
India and the UK’s new free trade agreement focuses on reducing tariffs and boosting trade in sectors such as automobiles, Scotch whisky, leather goods, and textiles. It intentionally excludes contentious clauses like data exclusivity to support domestic healthcare access and affordability.
