Health Ministry Notifies NDCT Rule Changes To Accelerate Drug Approvals

The Union Ministry of Health and Family Welfare on Wednesday notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing drug development timelines and strengthening India’s pharmaceutical research ecosystem.

The amendments simplify regulatory procedures, reduce approval timelines, and promote ease of doing business for pharmaceutical companies.

The reforms cut at least 90 days from the drug development life cycle by enabling faster initiation of Bioavailability/Bioequivalence (BA/BE) studies, drug testing, and examination.

For applicable test licences, authorities have reduced statutory processing timelines from 90 days to 45 days.

Under the revised rules, companies no longer need a test licence for non-commercial manufacture of drugs for research or analysis.

Instead, a simple online intimation to the Central Drugs Standard Control Organisation (CDSCO) suffices, except for high-risk categories such as cytotoxic, narcotic, and psychotropic substances.

Similarly, certain low-risk BA/BE studies may now begin upon online intimation, expediting approvals for around 4,000–4,500 studies annually.

To ensure smooth implementation, dedicated online modules on the National Single Window System (NSWS) and the SUGAM portal will enable transparent, hassle-free submissions.

The reforms also optimise CDSCO manpower, improving efficiency and regulatory oversight.

According to the Ministry, the amendments align domestic regulations with global best practices, foster innovation, and strengthen India’s position as a preferred destination for pharmaceutical research and development.

By reducing procedural delays and regulatory burden, these reforms are expected to accelerate the growth of the Indian pharmaceutical sector and support the government’s vision of R&D-led industrial progress.