In trade discussions, India opposes the proposal from EFTA for data exclusivity

Commerce Secretary Sunil Barthwal said on Thursday that India has turned down the proposal of the four-nation European Free Trade Association (EFTA) for “data exclusivity” restrictions in the free trade pact that both sides are discussing.

Iceland, Liechtenstein, Norway, and Switzerland are nations that have chosen not to join the European Union and are members of EFTA.

Barthwal was responding to rumors that the Indian pharmaceutical sector will find it difficult to develop generic versions of off-patent drugs due to the need for data exclusivity.

The use of preclinical test and clinical trial data by generic medication manufacturers will be prohibited under data exclusivity restrictions pertaining to previous patent holders. Generic drug manufacturers will need to wait for the exclusivity period to finish or provide their own clinical evidence before launching their own version of an off-patent medication.

“The Indian generic industry has nothing to fear (from this agreement).” Indeed, ensuring the success of the generic medication business is our top priority, Barthwal said reporters.

“We are there to protect the interest of the industry,” he said, adding that the sector makes a substantial contribution to India’s exports. An estimated $25 billion is spent on generic drugs in India, of which half is exported.

Since January 2008, India and EFTA have been engaged in negotiations for a Trade and Economic Partnership Agreement. Here in January, the 21st round of discussions took place covering a number of topics, including intellectual property rights, trade facilitation, trade and sustainable development, rules of origin, and trade in products.

The trade ministry said that the negotiations are at a very advanced level. India’s EFTA exports was $1.92 billion in FY23, while its imports were $16.74 billion.