Health Ministry notifies amendments to New Drugs and Clinical Trials Rules, 2019

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.

Under the existing regulatory framework, pharmaceutical 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. 

“As a result, the industry will no longer be required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in the case of a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs, and psychotropic substances,” explained a senior Health Ministry official.

This reform is expected to lead to a minimum saving of 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation. Also, for categories where test licences continue to be applicable, the statutory processing timeline has been reduced from 90 days to 45 days. 

“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,” said a release issued by the Health Ministry.

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 Ministry noted.

The reforms will also enable the Central Drugs Standard Control Organization to optimise utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight.

The initiative aims to promote research-led growth of the Indian pharmaceutical industry, align domestic regulations with global best practices, and strengthen India’s position as a preferred global destination for pharmaceutical research and development, noted the Ministry.