India has rejected demand for data exclusivity in drug development in FTA talks: Commerce Secretary

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Last Updated17/02/2024

India has dismissed the request for 'data exclusivity' during ongoing discussions with the European Free Trade Association (EFTA) for a free trade agreement.

The EFTA, comprising Switzerland, Norway, Iceland, and Lichtenstein, have consistently pushed for data exclusivity since 2008 in trade negotiations with India.
- EFTA is an inter-governmental organisation for the promotion and intensification of free trade.
India rejects it as such a clause would impede its thriving generic drug industry.
It has been pivotal in providing affordable alternatives to expensive medications globally.
- India’s generic drug industry is estimated at about USD 25 billion and the country exports 50% of its produce.

It involves a provision in the draft agreement proposing a minimum six-year embargo on clinical trial data produced during drug testing and development.
This clause would compel manufacturers seeking to replicate a drug to
- Either generate their own data, which is costly
- Or wait out the embargo period before selling their version in India.
Through it, innovator firms can prevent competitors from obtaining marketing licenses for low-cost versions during the exclusivity period.
This regulation could also impact drugs not patented in India.
Data exclusivity is beyond the provisions of the TRIPS agreement under the WTO (World Trade Organisation).