Health Ministry to amend 2019 rules for new drugs, clinical trials

Aimed at promoting ease of doing business in the pharmaceutical and clinical research sectors, the Union Health Ministry is set to amend the New Drugs and Clinical Trials Rules, 2019.

The proposed amendments were published in The Gazette of India on August 28, seeking public comments.

The amendments aim to simplify the requirements and procedures for obtaining test licences, and for submitting applications related to studies on bioavailability/bioequivalence.

The key highlights of the proposed amendments, according to the release issued by the Health Ministry on Wednesday (September 3, 2025), includes easing up application processes for test licences, and for studies on bioavailability/bioequivalence.

Under the proposed amendment, the present system for test licenses has been converted to a notification and intimation system, the statement said.

“Through this, the applicants need not wait for test licenses (except a small category of high-risk category drugs) but will need to just intimate the Central Licensing Authority. Additionally, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days,’’ the Ministry said.

Thus, under the amendment, the existing licence requirement will be dispensed with for certain categories of bioavailability/bioequivalence studies, which may instead be initiated upon the 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. They will also reduce the number of applications for test licenses being submitted by approximately 50%.

“This will facilitate quicker initiation of bioavailability/bioequivalence studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes,’’ the Ministry said.

The amendments would enable the Central Drugs Standard Control Organisation to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight, the Health Ministry said.