The Union Health Ministry on Wednesday announced plans to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 to promote ease of doing business in the pharmaceutical and clinical research sectors.
The draft amendments, published in the Gazette of India on August 28 for public feedback, aim to simplify procedures for obtaining test licences and submitting applications for Bioavailability/Bioequivalence (BA/BE) studies.
“These reforms are part of the government’s ongoing efforts to align domestic regulations with global best practices and to strengthen India’s position as a hub for pharmaceutical research and development,” the Ministry said.
Key proposals include:
Conversion of test licences to an intimation system: Applicants, except for high-risk drugs, would no longer need to wait for approvals and could proceed after notifying the Central Licensing Authority.
Reduced processing timelines: The statutory period for test licence applications will be cut from 90 days to 45 days.
Exemption for certain BA/BE studies: Licences would no longer be required for specific categories, which could commence upon notification.
According to the Ministry, these changes will halve the number of licence applications submitted, speed up BA/BE studies, testing and examination of drugs, and reduce delays in drug development and approvals.
The reforms are also expected to help the Central Drugs Standard Control Organization (CDSCO) better utilise its manpower, improving regulatory efficiency and oversight.
