India Rejects Data Exclusivity Demand In FTA Talks To Support Generic Drugs Industry

New Delhi, Feb 16 (KNN) India has firmly rejected the demand for 'data exclusivity' provision in the Free Trade Agreement (FTA) negotiations, affirming its commitment to supporting the interests of its generic drugs industry.

Commerce Secretary Sunil Barthwal emphasised this stance, stating that India stands with its generic industry and will not compromise its interests in any FTA agreements, reported businessline.

The European Free Trade Association (EFTA) bloc, which includes Iceland, Liechtenstein, Norway, and Switzerland, had pushed for the inclusion of data exclusivity in the proposed FTA with India.

However, India dismissed this demand, signalling its dedication to protecting the flourishing generic drug industry.

This decision brings relief to the Indian generic industry, especially amidst ongoing negotiations with the UK and the EU, where demands for concessions beyond the Trade Related Intellectual Property Rights (TRIPS) agreement have been made. Despite pressure to extend commitments, India remains steadfast in its support for generic drugs.

Data exclusivity, which safeguards a pharmaceutical company's clinical trial data for a specific drug, hinders generic competitors from seeking regulatory approval based on the originator's data.

India's rejection of this provision underscores its commitment to preventing monopolies on original drugs, which would adversely impact generic drug manufacturers.

Notably, data exclusivity is not mandated under the TRIPS Agreement, and Indian laws do not provide for it.

India's generic medicines sector is significant, manufacturing approximately 60,000 different generic brands across 60 therapeutic categories and contributing 20 per cent to the global supply of generics.

(KNN Bureau)