Health Ministry to ease rules for new drug approvals and clinical trials
text_fields
New Delhi: The Union Health Ministry has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying procedures for the pharmaceutical and clinical research sectors as part of its push to promote ease of doing business.
The draft changes, published in the Gazette of India on August 28 for public feedback, seek to streamline requirements for test licenses and applications related to Bioavailability/Bioequivalence (BA/BE) studies.
According to the Ministry, the amendments are intended to reduce red tape, align domestic regulations with global best practices, and strengthen India’s position as a hub for pharmaceutical research and development.
A key proposal is to replace the current licensing process for test licenses with a notification or intimation system. Applicants would no longer need to wait for formal approval, except in the case of certain high-risk drugs, and could begin trials by notifying the Central Licensing Authority. The statutory processing time for test license applications would also be cut from 90 days to 45 days.
The draft rules further suggest scrapping the license requirement for some categories of BA/BE studies, which could instead commence upon notification to the authority.
The Ministry said the reforms would halve the number of license applications, speed up the initiation of drug testing and clinical studies, and reduce delays in the development and approval of new medicines.
It added that the changes would also help the Central Drugs Standard Control Organization (CDSCO) make better use of its manpower, thereby improving regulatory efficiency.
