Daijiworld Media Network – New Delhi

New Delhi, Jan 28: The Union Ministry of Health and Family Welfare on Wednesday notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing drug development timelines and strengthening India’s clinical research and pharmaceutical development ecosystem.

The ministry said the reforms are intended to simplify regulatory processes, reduce approval timelines and promote ease of doing business, while ensuring public health and safety.

“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.

According to the ministry, the amendments will help save a minimum of 90 days in the drug development life cycle. For categories where test licences continue to apply, the statutory processing timeline has been reduced from 90 days to 45 days.

Test licence replaced with prior-intimation mechanism

Under the existing system, pharmaceutical companies were required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for manufacturing small quantities of drugs for examination, research or analysis.

This requirement has now 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 processes nearly 30,000 to 35,000 test licence applications annually, and the change is expected to significantly reduce regulatory burden.

Simplified process for low-risk BA/BE studies

The amendment also removes the need for prior permission for certain categories of low-risk Bioavailability/Bioequivalence (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,” the ministry said.

CDSCO processes around 4,000 to 4,500 BA/BE study applications every year, and the revised mechanism is expected to reduce delays.
Online modules to be enabled

To ensure smooth implementation, dedicated online modules will be introduced on the National Single Window System (NSWS) and the SUGAM portal, enabling transparent and hassle-free submission of intimations.

The ministry added that the reforms will also allow CDSCO to optimise its manpower, improving the efficiency and effectiveness of regulatory oversight.