The Ministry of Health and Family Welfare (“MoHFW”) has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019 (“NDCT Rules”) for public consultation. The proposed changes cover the application of unapproved drugs for conduct of bioavailability/bioequivalence (“BA/BE”) studies for export purposes and the requirements relating to test licenses for manufacture of new drugs or investigational new drugs. Stakeholders are invited to provide objections/suggestions by 27th September 2025.

Key Highlights:

1. Application of unapproved drugs for BA/BE studies for export purposes

1. 1. At present, BA/BE studies with unapproved drugs can only be conducted after receiving prior permission from the Central Licensing Authority. The draft proposes that for certain types of BA/BE studies in healthy adult volunteers, a notification to the authority will suffice instead of prior approval.
   2. Currently, there is no differentiation based on whether a drug is approved elsewhere. Under the draft, this relaxation will apply only if the drug is already approved either in India or in major jurisdictions such as the USA, EU, Japan, Australia, Canada, or the UK.
   3. The present rules do not specify any exclusions. The draft explicitly excludes drugs such as cytotoxic medicines, hormones, narcotics, and psychotropics from this relaxation.
   4. Ethics Committee approval is already mandatory. The draft continues this requirement but further requires Committees to keep detailed records of their review, which may be checked when their registration is renewed.
   5. At present, there is no limit on the number of participants in such studies. The draft introduces a cap of 48 subjects.
   6. Currently, applications are made through the standard clinical trial form with prescribed fees. The draft instead requires online submission in a new format, with government-funded organizations continuing to be exempt from fees.

2. Changes to Test License requirements

1. 1. As of now, manufacturing a new drug or an investigational new drug for clinical trials, BA/BE studies, or analysis always requires prior permission from the Central Licensing Authority. The draft proposes that, in some cases, such manufacture may be done through either prior permission or an online notification, depending on the circumstances.
   2. Today, even manufacturing for analytical or non-clinical research requires prior approval. The draft allows certain drugs excluding sex hormones, cytotoxic drugs, beta-lactams, biologics with live microorganisms, narcotics, and psychotropics to be manufactured based on a simple notification.
   3. The current timeline for the Central Licensing Authority to decide on applications is 90 working days. The draft shortens this to 45 working days, thereby speeding up the approval process.

The comments/suggestions may be shared through the following modes:

1. Send to address: Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi – 110011, or
2. Email Submission: Comments can be sent to drugsdiv-mohfw@gov.in.

Source: Ministry of Health and Family Welfare

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