Government News

In a move aimed at accelerating drug development while maintaining regulatory oversight, India’s drug regulator has notified sweeping changes to the New Drugs and Clinical Trials (NDCT) Rules, 2019, introducing a faster “prior intimation” route for select test licences and sharply reducing approval timelines.

The amendments, notified on January 20, 2026, under G.S.R. 46(E), mark a significant shift in how manufacturers can produce new drugs and investigational products for clinical trials, bioavailability, bioequivalence studies, and analytical testing

The proposed India-European Union (EU) trade deal is expected to bring significant benefits to India’s pharmaceutical industry. The EU is one of the largest and most regulated medicine markets in the world, and easier access to this region can open new growth opportunities for Indian drug manufacturers. The agreement focuses not only on trade but also on regulatory cooperation, which is crucial for pharmaceuticals.

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 37 new drug formulations under the Drugs (Prices Control) Order (DPCO), 2013, through an order issued on December 24, 2025. The decision, published in the Gazette of India, aims to regulate the prices of commonly used medicines across therapeutic segments, while ensuring affordability and transparency for consumers.