Daijiworld Media Network - New Delhi

New Delhi, Sep 3: The Union Health Ministry announced on Wednesday its intention to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, in a move to simplify regulations and promote ease of doing business in the pharmaceutical and clinical research sectors. The proposed changes, which were published in the Gazette of India on August 28 for public comment, aim to streamline processes for obtaining test licenses and conducting Bioavailability/Bioequivalence (BA/BE) studies.

The initiative is part of a broader government effort to foster the growth of the Indian pharmaceutical industry and align domestic regulations with international best practices. These reforms are expected to enhance India’s appeal as a hub for clinical research and drug development.

One of the key amendments is the proposed shift from a license-based system to a notification-based one for test licenses. This change will allow applicants to proceed with their studies after simply informing the Central Licensing Authority, without having to wait for a license, except for high-risk category drugs. Additionally, the statutory processing time for test license applications will be reduced from 90 to 45 days.

The Ministry also intends to eliminate the licensing requirement for certain BA/BE studies, allowing them to begin after a notification is submitted to the Central Licensing Authority.

These reforms are expected to significantly reduce processing times, cut the number of license applications by roughly 50%, and accelerate the initiation of studies and drug development processes. The changes will also enable the Central Drugs Standard Control Organization (CDSCO) to optimize its resources, improving the efficiency of its regulatory oversight.