India Asserts Position, Rejects European FTA Demand to Safeguard Generic Drug Industry

India has firmly stated its rejection of the European Free Trade Association (EFTA) bloc’s request to include a ‘data exclusivity’ provision in proposed free trade agreements, reaffirming its commitment to safeguarding the interests of its domestic generic drugs sector. Commerce Secretary Sunil Barthwal emphasized India’s unwavering support for its generic drug industry, asserting that the country would not compromise its interests in any negotiations regarding free trade agreements.

The EFTA, consisting of Iceland, Liechtenstein, Norway, and Switzerland, has been engaged in discussions with India regarding a potential trade agreement aimed at fostering closer economic ties between the parties. Barthwal clarified India’s stance, stating, “They want that there should be data exclusivity, we rejected their demand. We are with our generic industry.” He underscored the critical role played by India’s generic drug industry, highlighting its significant contribution to the country’s exports and overall economic growth.

Data exclusivity, a provision that grants protection to the technical data generated by innovator companies to demonstrate the efficacy and safety of their products, emerged as a key point of contention in the negotiations. By securing exclusive rights over this data, innovator companies can prevent competitors from obtaining marketing licenses for cheaper generic versions during the exclusivity period. Switzerland, home to major pharmaceutical firms like Novartis and Roche, has a vested interest in such provisions. However, India’s rejection of data exclusivity aligns with its steadfast commitment to supporting its robust generic drug industry.

India’s generic drug industry, valued at approximately USD 25 billion, plays a pivotal role in the global pharmaceutical trade landscape, with the country exporting around 50 percent of its production to various markets worldwide. The negotiations between India and EFTA, officially referred to as the Trade and Economic Partnership Agreement (TEPA), have been ongoing since January 2008, covering a wide range of issues such as trade in goods, intellectual property rights, and trade facilitation.

Despite the inherent complexities involved, both parties have made significant progress in the negotiations, which are now said to be at an advanced stage. EFTA, boasting 29 FTAs with 40 partner countries, operates as an inter-governmental organization committed to promoting free trade and economic cooperation. While India’s exports to EFTA countries have shown steady growth over the years, imports from the bloc have witnessed a decline in recent years, resulting in a trade gap that favors the EFTA group, according to data from the commerce ministry. This underscores the need for India to negotiate agreements that prioritize its economic interests while fostering mutually beneficial trade relations with its partners.

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