The government announced on Thursday that it has decided to reject the demand from the four European nations in the European Free Trade Association (EFTA) bloc to include a 'data exclusivity' provision in proposed Free Trade Agreements (FTA). India emphasised its commitment to safeguarding the interests of the domestic generic drugs industry.
Commerce Secretary Sunil Barthwal stated that India will not enter into any FTA that compromises the interests of the generic drug industry. The EFTA comprises Iceland, Liechtenstein, Norway, and Switzerland. The bloc is currently engaged in negotiations for a trade agreement with India.
"They want that there should be data exclusivity, we rejected their demand. We are with our generic industry. There is no fear for Indian generic industry (from this agreement). In fact, it is our very important objective to see that generic drug industry flourishes," Barthwal told the news agency PTI.
The secretary emphasised that the industry is making a substantial contribution to India's exports, which are also experiencing growth. “So we are there to protect the interest of the industry," he added.
Data exclusivity protects the technical data produced by innovator companies to demonstrate the effectiveness of their products. In the pharmaceutical sector, drug companies conduct costly global clinical trials to generate data validating the efficacy and safety of their new medications.
By securing exclusive rights to this data, innovator companies can prevent competitors from obtaining marketing licenses for cheaper versions during the exclusivity period. Switzerland is home to some of the world's leading pharmaceutical companies, including Novartis and Roche.
The value of India's generic drug industry is estimated to be around $ 25 billion, with the country exporting approximately 50 per cent of its production.
An expert mentioned that data exclusivity goes beyond the provisions outlined in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization (WTO). India and the EFTA have been negotiating the pact, officially known as the Trade and Economic Partnership Agreement (TEPA), since January 2008 to enhance their economic relations.