Author name: Ananta Kar

Ninety days. That’s how much time a pharmaceutical manufacturer can now save bringing a generic drug or biosimilar to Indian patients. On 28th January 2026, the Union Health Ministry unveiled sweeping amendments to the New Drugs and Clinical Trials Rules 2019, abolishing test licence requirements and introducing simple online intimation for bioavailability and bioequivalence studies

A generic drug manufacturer in Gujarat can now access all 27 European Union markets without paying a single rupee in tariffs. A medical device producer in Maharashtra suddenly faces European competition arriving 15 per cent cheaper than before. Both outcomes stem from the same transformative agreement. The India-EU Free Trade Agreement, sealed on 27th January

A cancer patient in Mumbai could soon pay 15 per cent less for European biologics. An Indian pharmaceutical manufacturer might capture new European markets worth billions. Yet the same trade agreement enabling both outcomes has sparked fierce debate about whether India‘s generic drug industry—supplying 20 per cent of global generics and keeping essential medicines affordable