Pharma Research To Get Boost As Government Eases Licence Norms

In a move to fast-track drug research, the Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, that will halve licence applications and reduce approval timelines.

This is aimed at reducing regulatory compliance and promoting ease of doing business in India's pharmaceutical and clinical research sectors.

The proposed changes, published in the Gazette of India on August 28 and now open for public comments, focus on simplifying the process for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.

Under the new system, test licence applications will shift from a licensing model to a notification or intimation-based system. This means applicants, except those dealing with a small category of high-risk drugs, will only need to inform the Central Licensing Authority instead of waiting for approval. The statutory processing time for such applications will also be cut from 90 days to 45 days.

For BA/BE studies, certain categories will no longer require licences. Instead, these studies can begin after applicants submit an intimation to the Central Licensing Authority.

According to the ministry, these measures are expected to cut licence applications by nearly 50 per cent, leading to faster initiation of BA/BE studies and drug testing. The reforms are also designed to reduce delays in drug development and approvals while allowing the Central Drugs Standard Control Organization (CDSCO) to deploy its human resources more efficiently.