Pharma & Healthcare Update

India–UK FTA May Boost Pharma Exports

This article was first published in bwlegalworld.com (August, 01, 2025).

The recently signed India-UK Comprehensive Economic and Trade Agreement (CETA) is being welcomed by the pharmaceutical industry in India for protecting provisions in the Patent Act, 1970 and increasing export opportunities. However, experts fear that the agreement may weaken India’s safeguards on compulsory licensing and tilt the balance toward big pharmaceutical companies.

According to the Ministry of Commerce and Industry, the CETA does not mandate provisions that extend patent terms or introduce data exclusivity. These are the two common tools used to prolong monopoly rights over drugs beyond the original patent period. This is seen as a major win for India’s USD 25 billion generic drug industry, which exports about half of its output globally. The ministry said that Section 3(d) of the Patent Act remains intact and fully protected.

Section 3(d) prohibits companies from extending their patent monopoly by making minor modifications to existing drugs (like changing the form, dosage or salt composition) and claiming them as new inventions, unless they show a significant improvement in therapeutic efficacy.

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Authors

- Priyadarsini S, Abhay Porwal and Tanya Kukade

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