Govt Amends NDCT Rules to Cut Drug Approval Timelines

30 Jan 2026 CW Team

The Union Ministry of Health and Family Welfare has recently 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 changes focus on simplifying approval processes and significantly shortening timelines for drug development and clinical research.

Under the revised framework, the requirement for pharmaceutical companies to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for non-commercial manufacture of small quantities of drugs for research or analysis has been replaced with a prior-intimation system. Companies may now proceed after submitting an online intimation, except for a limited category of high-risk drugs such as cytotoxic, narcotic and psychotropic substances. This move is expected to save at least 90 days in the drug development cycle.

For categories where test licences continue to apply, the statutory processing timeline has been reduced from 90 days to 45 days. With CDSCO handling nearly 30,000–35,000 such applications annually, the reform is expected to substantially ease compliance requirements for the industry.

In another major change, prior approval for certain low-risk Bioavailability and Bioequivalence (BA/BE) studies has been waived. These studies can now commence based on a simple online intimation, benefiting the generic pharmaceutical segment. CDSCO processes around 4,000–4,500 BA/BE applications each year.

Dedicated online modules on the National Single Window System and the SUGAM portal will support seamless implementation. Overall, the reforms are expected to accelerate research, optimise regulatory resources, and strengthen India’s position as a global hub for pharmaceutical R&D.

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