Health ministry amends NDCT Rules, 2019 to reduce regulatory burden and promote ease of doing business

Union Ministry of Health and Family Welfare has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 to reduce regulatory burden and promote Ease of Doing Business. These amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharma development in the country.

Under the existing regulatory framework, pharma companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, this licensing requirement for non-commercial manufacture has been replaced with a prior-intimation mechanism. 

The amendment to NDCT Rules, 2019 will lead to a minimum saving of 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation. Furthermore, for categories where test licences continue to be applicable, the statutory processing timeline has been reduced from 90 days to 45 days. Considering that CDSCO processes approximately 30,000 to 35,000 test licence applications annually, the reform is expected to substantially reduce regulatory burden and benefit a large number of stakeholders.

In another important step to expedite clinical research, the requirement of obtaining prior permission for certain categories of low-risk Bioavailability/Bioequivalence (BA/BE) studies has been dispensed with. Such studies may now be initiated on the basis of a simple online intimation to CDSCO, enabling faster commencement of studies, particularly for the generic pharmaceutical industry. CDSCO processes around 4,000 to 4,500 BA/BE study applications every year, and the revised mechanism is expected to significantly reduce procedural delays.

To ensure smooth and seamless implementation of these changes, dedicated online modules will be made available on the National Single Window System (NSWS) and the SUGAM portal, allowing industry to submit intimations in a transparent and hassle-free manner.

Overall, these regulatory reforms are expected to provide substantial benefits to stakeholders while ensuring public health and safety. By significantly reducing timelines for regulatory processing, the amendments will facilitate quicker initiation of BA/BE studies, testing, and examination of drugs for research purposes, and minimise delays across the drug development and approval continuum. The reforms will also enable the Central Drugs Standard Control Organization (CDSCO) to optimise utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight.

Commenting on the announcement, Sanjay Vyas, President, Global Head-Clinical Logistics and Patient Safety & Pharmacovigilence and Managing Director India at Parexel said, “These amendments signal a clear shift towards proportionate and risk-based regulation in India’s clinical research framework. Removing the test licence requirement for non-commercial manufacture and easing approvals for select bioavailability and bioequivalence studies directly addresses long-standing execution bottlenecks. The real impact lies in predictability. Shorter and more certain regulatory timelines allow sponsors to plan studies with greater confidence and allocate resources more efficiently. Over time, this can meaningfully improve India’s competitiveness in global drug development, not just on cost, but on reliability, speed, and regulatory maturity.”