Centre set to amend rules to simplify drug testing process

New Delhi: The Centre is set to amend the New Drugs and Clinical Trials Rules, 2019, that would halve the statutory time to process applications for test licences to manufacture or use a new drug in clinical trials, promoting ease of doing business in the pharmaceutical sector.

The Union health ministry sought public comments on the proposed amendments to the rules through a gazette notification on August 28. It said the proposed changes aim to simplify the requirements and procedures for obtaining test licences and for submitting applications for bioavailability/bioequivalence (BA/BE) studies.

The amendments look to dispense with the existing licence requirement for certain categories of BA/BE studies, which may instead be initiated upon submission of an intimation or notification to the Central Licensing Authority.


Moreover, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.

According to the ministry, these regulatory reforms are expected to benefit stakeholders by significantly reducing the time for processing applications.

"It would also reduce the number of licence applications being submitted by approximately 50 per cent. This will facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes," it stated.

The amendments will also enable the Central Drugs Standard Control Organisation (CDSCO) to optimise the deployment of its human resources.