India streamlines drug approvals, cutting development time by 90+ days via faster licensing and online submissions.

India has updated its New Drugs and Clinical Trials Rules to cut drug development timelines by at least 90 days. The changes replace test licence requirements for non-commercial drug manufacturing with a prior online intimation to CDSCO, except for high-risk drugs, and reduce licence processing time from 90 to 45 days. Low-risk BA/BE studies no longer need prior approval, allowing them to begin after intimation. Online submissions via the National Single Window System and SUGAM portal will improve transparency and efficiency, supporting faster regulatory review and boosting pharmaceutical innovation.