Government Amends NDCT Rules to Fast-Track Drug Development

In January 2026, the Union Ministry of Health and Family Welfare notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce drug development timelines and strengthen India’s clinical research and pharmaceutical development ecosystem.

Key Points

Regulatory Simplification: The amendments aim to simplify regulatory processes, reduce approval timelines, and promote ease of doing business in the pharmaceutical sector.
Reduced Timelines: The drug development life cycle will save a minimum of 90 days, and for categories requiring test licences, the processing timeline has been reduced from 90 days to 45 days.
Test Licence Reform: The requirement to obtain a test licence for non-commercial manufacture of drugs has been replaced with a prior online intimation to CDSCO, except for high-risk drugs such as cytotoxic, narcotic, and psychotropic substances.
Lower Regulatory Burden: CDSCO processes around 30,000–35,000 test licence applications annually, and the new mechanism will significantly reduce procedural load on regulators and industry.
Faster BA/BE Studies: Prior permission requirements have been removed for certain low-risk bioavailability and bioequivalence studies, allowing them to commence through simple online intimation, thereby benefiting the generic pharmaceutical industry.
Digital Enablement: Dedicated online modules will be introduced on the National Single Window System and the SUGAM portal to ensure transparent and seamless submission of intimations.
Improved Regulatory Oversight: The reforms will enable CDSCO to optimise manpower utilisation, enhancing the efficiency and effectiveness of regulatory oversight while ensuring public health and safety.