The government has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce regulatory burden and promote ease of doing business. The Ministry of Health and Family Welfare said that these amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country. As per the Ministry, through the notified amendments, the licensing requirement for non-commercial manufacture has been replaced with a prior-intimation mechanism.

The Ministry said that this reform is expected to lead to a minimum saving of 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation. Furthermore, for categories where test licences continue to be applicable, the statutory processing timeline has been reduced from 90 days to 45 days.

The Ministry added that the reform is expected to substantially reduce regulatory burden and benefit a large number of stakeholders. The Ministry informed that to expedite clinical research, the requirement of obtaining prior permission for certain categories of low-risk Bioavailability-Bioequivalence studies has also been dispensed. To ensure smooth and seamless implementation of these changes, dedicated online modules will be made available on the National Single Window System and the SUGAM portal.