The central government has reduced the approval timeline for applications to manufacture drugs meant for clinical trials, a move aimed at accelerating clinical research and drug development in India.

Under amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, the review period for granting permission to manufacture trial drugs has been cut from 90 working days to 45 working days. The revised timeline applies to applications for manufacturing new drugs for clinical trials, bioavailability and bioequivalence (BA/BE) studies, and related testing purposes.

In addition to shortening approval timelines, the amendment introduces a notification-based system for certain preclinical and analytical testing activities, further simplifying regulatory requirements and enabling faster initiation of research work.

The changes follow recommendations from the Drugs Technical Advisory Board and reflect the government’s broader efforts to strengthen India’s clinical research ecosystem, improve regulatory efficiency, and position the country as a preferred destination for drug development and clinical trials.

The revised timelines are expected to come into effect after the notified implementation period following publication in the official gazette.