CDSCO eases Test Licence Pathway, cuts approval timelines under NDCT Rules Amendment 2026
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










