MoHFW issued GSR 46(E) dated 20 January 2026, amending the New Drugs and Clinical Trials Rules 2019. Approval timelines reduced from 90 to 45 working days. New prior intimation pathway under Rule 52: manufacturers for analytical and non-clinical testing can proceed on acknowledgment of online intimation.
50% reduction in statutory approval timelines. Prior intimation pathway differentiates risk categories for the first time in CDSCO's framework. Positions India to compete with the US, EU, and APAC for global clinical development.