The Ministry of Health and Family Welfare (MoH&FW) on January 22, 2026, issued the New Drugs and Clinical Trials (Second Amendment) Rules, 2026, further to amend the New Drugs and Clinical Trials Rules, 2019.
This shall come into force after ninety days from January 27, 2026.
The following has been amended, namely: -
• The amendment rules introduce a significant shift towards regulatory simplification by allowing certain export-oriented bioavailability and bioequivalence studies of oral drugs, already approved in India or select regulated countries, to be conducted based on prior intimation instead of prior permission, subject to defined safeguards such as Ethics Committee approval and minimum sample size.
• The amendments comprehensively align related provisions to recognise “permission or prior intimation”, rationalise fees by exempting government-funded institutions, and provide clarity on the validity and extension of approvals.
• Overall, the changes aim to reduce procedural delays, lower compliance burden, and facilitate faster conduct of clinical studies, while retaining necessary regulatory oversight.
[Notification no. - G.S.R. 50(E)]
