The Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing regulatory compliance and promoting ease of doing business in the pharmaceutical and clinical research sectors.

The proposed amendments were published in the Gazette of India on August 28, 2025, seeking public comments. The key objective is to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.

Under the proposed changes, the existing licensing system for test licences will be replaced with a notification or intimation system. Except for a small category of high-risk drugs, applicants will no longer need to wait for licence approvals and can instead simply notify the Central Licensing Authority. Additionally, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.

Similarly, the amendment proposes doing away with licence requirements for certain categories of BA/BE studies, allowing them to be initiated upon submission of an intimation or notification to the Central Licensing Authority.

These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications.

According to the Ministry, these proposed amendments will reduce the number of license applications being submitted by approximately 50 percent, enabling quicker initiation of BA/BE studies, testing, and examination of drugs for research, thereby reducing delays in the drug development and approval processes.

Moreover, the amendments will enable the Central Drugs Standard Control Organization (CDSCO) to optimise the deployment of its human resources, and thus enhance the efficiency and effectiveness of regulatory oversight.

This initiative is part of the Government’s ongoing regulatory reforms designed to boost the growth of the Indian pharma industry, align domestic regulations with global best practices, and strengthen the country’s position as a global hub for pharmaceutical research and development.