Government Notifies NDCT Rule Amendments to Speed Up Drug Approvals and Clinical Research

January 28, 2026 : The central government has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing regulatory burden and improving ease of doing business in the pharmaceutical sector.

The Ministry of Health and Family Welfare said the changes are designed to simplify regulatory procedures, shorten approval timelines, and enable faster conduct of clinical research and drug development in India. One of the major reforms replaces the licensing requirement for non-commercial manufacture with a prior-intimation mechanism, significantly easing compliance for researchers and institutions.

According to the Ministry, this move alone is expected to save at least 90 days in the drug development life cycle, giving a strong push to pharmaceutical research and innovation. In cases where test licences are still required, the statutory processing timeline has been cut in half, from 90 days to 45 days.

To further accelerate clinical research, the government has also removed the requirement of prior permission for certain categories of low-risk Bioavailability and Bioequivalence (BA-BE) studies. The Ministry said these measures will substantially reduce regulatory hurdles and benefit a wide range of stakeholders, including researchers, academic institutions, and the pharmaceutical industry.

For smooth implementation of the amended rules, dedicated online modules will be introduced on the National Single Window System and the SUGAM portal, ensuring a more streamlined and transparent regulatory process.