The Union Ministry of Health and Family Welfare notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, on Wednesday. These amendments will reduce drug development timelines and strengthen the clinical research and pharmaceutical development ecosystem.
The amendments aim to simplify regulatory processes, reduce approval timelines, and promote ease of doing business.
The regulatory reforms will provide substantial benefits to stakeholders while ensuring public health and safety. They will also facilitate quicker initiation of Bioavailability/Bioequivalence (BA/BE) studies, testing, and examination of drugs for research purposes, and they will minimize delays across the drug development and approval continuum.
“The 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 Ministry said.
“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,” it added.
As per the amendment, the drug development life cycle will save a minimum of 90 days. For categories where test licences continue to be applicable, the statutory processing timeline has been reduced from 90 days to 45 days, the Ministry said.
Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for manufacturing small quantities of drugs intended for examination, research, or analysis purposes.
This licensing requirement for non-commercial manufacture has been replaced with a prior-intimation mechanism.
“The industry will no longer be required to seek a test licence. It 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,” the Ministry said.
The CDSCO annually processes approximately 30,000 to 35,000 test licence applications. The new reform will substantially reduce the regulatory burden and benefit a large number of stakeholders.
Further, the amendment disposes of the requirement to obtain prior permission for certain categories of low-risk BA/BE studies.
“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,” the Ministry said.
In addition, 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. These will allow the industry to submit intimations in a transparent and hassle-free manner.
The reforms will also enable the CDSCO to optimise the utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight.
-IANS
