The Ministry of Health and Family Welfare has published a draft notification proposing several amendments to the New Drugs and Clinical Trials Rules, 2019. The changes are designed to streamline the manufacturing process for new drugs and investigational new drugs, particularly for analytical and preclinical testing, and to accelerate the review timelines for applications. The draft rules are now open for public comments till September 27, 2025.
The proposed amendments were made in consultation with the Drugs Technical Advisory Board and aim to enhance the ease of doing business for the pharmaceutical sector while maintaining regulatory oversight.
Key Proposed Amendments
A major change is the introduction of a new provision for the manufacture of new drugs or investigational new drugs intended for analytical and preclinical testing. For most of these drugs, manufacturers can now submit an online application as a notification and begin manufacturing based on this notification, without waiting for explicit permission.
This streamlined notification process does not apply to a specific list of high-risk drugs, including sex hormones, cytotoxic drugs, beta lactam drugs, biologics with live microorganisms, and narcotics & psychotropic drugs. For these categories, the traditional permission process remains in place.
The draft rules propose to significantly reduce the waiting periods for several application processes.
The period for considering various applications under Rules 53 and 60 has been reduced from ninety working days to forty-five working days. This is expected to expedite the approval of applications for clinical trials, bioavailability, and bioequivalence studies, as well as the import of new drugs.
The draft rules also substitute the existing sub-rule (1) of Rule 52, clarifying that no person shall manufacture a new drug or investigational new drug for clinical trials or other studies without obtaining either explicit permission or by submitting a notification to the Central Licensing Authority, as applicable.
The Ministry has invited objections and suggestions on these draft rules. Comments can be addressed to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare or emailed to drugsdiv-mohfw@gov.in till September 27, 2025.