NEW DELHI: To reduce regulatory burden and promote ease of doing business, the Centre has amended the New Drugs and Clinical Trials (NDCT) Rules, 2019, to boost pharmaceutical research and innovation in the country.
The Union Health Ministry notified the key amendment with the aim of simplifying the regulatory process, reducing approval timelines and enabling faster conduct of clinical research and pharmaceutical development in the country.
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 directives from Prime Minister Narendra Modi to reduce regulatory burden and promote ease of doing business, the Ministry said in a statement.
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.
This reform, the Ministry said, will 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 hurdles, the centre aims to reduce regulatory burden on a large number of industry stakeholders.
The Ministry 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,” the Ministry added.
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, the statement said.
The reforms will also enable the CDSCO to optimise utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight.
“These measures underscore the Government of India’s commitment to continuous, trust-based regulatory reforms in the pharmaceutical sector, in line with the Jan Vishwas Siddhant and the broader Ease of Doing Business framework. The initiative aims to promote R&D-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,” the statement added.