India hasn't accepted UK 'data exclusivity' demand in FTA to protect generic drug firms
CHENNAI: India has declined the United Kingdom's request to include a ‘data exclusivity’ clause in the Free Trade Agreement (FTA) announced on May 6, in order to protect the interests of its domestic generic drug industry, a Commerce ministry official confirmed.
During the FTA negotiations, the UK proposed adding a provision that would grant exclusive rights over clinical trial data to innovator pharmaceutical companies. However, Indian officials did not agree to this request.
“There is no threat to the Indian generic drug industry from this agreement. In fact, ensuring the growth of the generic sector is one of our key priorities,” sources in the Commerce Ministry were quoted as saying by news agencies.
India’s generic pharmaceutical sector plays a significant role in the country’s exports, which continue to grow. The industry is valued at around USD 25 billion, with nearly 50% of its output being exported.
What is Data Exclusivity
Data exclusivity protects the clinical trial data that innovator companies generate to prove the safety and effectiveness of new drugs. This protection can prevent competitors from using the same data to gain marketing approval for cheaper generic versions during the exclusivity period.
By securing exclusive rights to their data, original drug makers can delay the entry of low-cost alternatives into the market.
India had earlier rejected a similar demand from the four-member European Free Trade Association (EFTA)—comprising Iceland, Liechtenstein, Norway, and Switzerland—during FTA talks concluded in March 2023. That agreement is expected to come into force later this year.
Some of the world’s leading pharmaceutical companies, such as AstraZeneca and GSK (UK), and Novartis and Roche (Switzerland), are based in these countries.
An expert noted that the concept of data exclusivity goes beyond the scope of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which India adheres to.
The India–UK FTA, announced on May 6, includes mutual benefits: British Scotch whisky and cars will become cheaper in India, while tariffs on Indian exports like garments and leather goods to the UK will be reduced.