India has rejected the demand of the four-nation European Free Trade Association (EFTA) for ‘data exclusivity’ provisions in the free trade agreement that both sides are negotiating, commerce secretary Sunil Barthwal said on Thursday.
EFTA’s members — Iceland, Liechtenstein, Norway, and Switzerland — are countries that have opted out of the European Union.
Barthwal was reacting to reports that the demand for data exclusivity would make it difficult for the Indian pharma industry to produce generic variants of off-patent products.
Data exclusivity provisions will bar generic drug producers from using data of preclinical tests and clinical trials of former patent holders. If generic medicine makers wish to introduce their version of an off-patent drug then they will have to either generate their own clinical data or wait for the exclusivity period to end.
“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,” Barthwal told reporters.
The industry is contributing significantly to India’s exports and “we are there to protect the interest of the industry”, he added. India’s generic drug industry is estimated at about $25 billion, half of which is exported.
India and EFTA have been negotiating the Trade and Economic Partnership Agreement since January 2008. The 21st round of negotiations was held here in January on chapters including trade in goods, rules of origin, trade and sustainable development, intellectual property rights, and trade facilitation.
According to the commerce ministry, the talks are at an advanced stage. In FY23, India’s exports to EFTA countries stood at $1.92 billion and imports at $16.74 billion.