Govt notifies norms to skip test licensing for drug R&D to boost ease of doing business

New Delhi: With an aim to streamline pharmaceutical development, the Union Health Ministry has notified amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019.

Under the new regulations, pharmaceutical companies are no longer required to obtain a test licence for manufacturing drugs in small quantities for research and analysis, provided they submit an online intimation to the Central Drugs Standard Control Organisation (CDSCO), except in certain cases.

The amendment is in line with the directions of Prime Minister Narendra Modi to reduce regulatory burden and promote ease of doing business, the ministry said.

Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the CDSCO for manufacturing drugs in small quantities intended for examination, research or analysis purposes.

This shift from a licensing requirement to a prior-intimation mechanism applies to non-commercial manufacture. However, a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs and psychotropic substances, will still require formal licences.

The ministry expects this reform to save at least 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation. For categories where test licences continue to be applicable, the statutory processing timeline has been halved from 90 days to 45 days.

The CDSCO currently processes between 30,000 and 35,000 test licence applications annually. By removing these procedural hurdle, the government aims to reduce regulatory burden on a large number of industry stakeholders.

The government has also dispensed with the requirement for prior permission for certain low-risk Bioavailability/Bioequivalence (BA/BE) studies. These studies, which are crucial for the generic pharmaceutical, can now be initiated on the basis of a simple online intimation.

The CDSCO processes around 4,000 to 4,500 BA/BE study applications each year. The revised mechanism is designed to eliminate delays and expedite the commercial clinical research.

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, the ministry said.

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, it said.

The reforms will also enable the CDSCO to optimise utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight.

The ministry said these reforms align with the "Jan Vishwas Siddhant" and the broader "Ease of Doing Business" framework. These measures underscore the government's commitment to continuous and trust-based regulatory reforms aimed at promoting research and development (R&D)-led growth of the Indian pharmaceutical sector, it added.