Government of India Notifies Draft Amendments to NDCT Rules- 2019

The Ministry of Health and Family Welfare, Government of India, has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, through a notification dated August 27, 2025. These amendments aim to simplify and streamline the process for conducting bioavailability and bioequivalence studies, particularly for drugs intended for export purposes. The draft rules, published for public consultation, reflect the government’s commitment to fostering innovation while ensuring regulatory compliance.

Key Highlights of the Proposed Amendments

Simplified Notification Process for Certain Studies The amendments introduce a provision for conducting single-dose, two-period, two-sequence, two-treatment bioavailability or bioequivalence studies in healthy adult volunteers for oral dosage forms of drugs. This applies to drugs already approved in India or specific countries like the USA, EU, Japan, Australia, Canada, and the UK.
- Drugs excluded from this provision include cytotoxic, hormone, narcotic, psychotropic substances, drugs with a narrow therapeutic index, or those with highly variable pharmacokinetics.
- Researchers can initiate these studies by submitting an online application as a notification, which will be acknowledged by the Central Licensing Authority.
Ethics Committee Approval and Oversight
- Applications must include approval from an ethics committee registered with the Central Licensing Authority.
- Ethics committees are required to maintain separate records of such studies, which will be reviewed during the renewal of their registration.
Sample Size Limitation
- The sample size for these studies is capped at 48 participants, ensuring ethical and manageable study conditions.
Fee Exemption for Government Institutions
- No fee will be charged for conducting bioavailability or bioequivalence studies by institutions or organizations owned or funded wholly or partially by the Central or State Government.

Implications of the Amendments

These amendments are a significant step toward simplifying the regulatory framework for bioavailability and bioequivalence studies. By introducing an online notification process, the government aims to reduce administrative hurdles and expedite the approval process for studies related to export-oriented drugs. The focus on ethics committee oversight ensures that the studies are conducted responsibly and transparently.

Additionally, the fee exemption for government institutions encourages public-sector research and development, fostering innovation in the pharmaceutical sector.

Public Consultation and Next Steps

The draft rules are open for public objections and suggestions for 30 days from the date of publication in the Gazette of India. Stakeholders can submit their feedback to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare via mail or email. This participatory approach ensures that the final rules reflect the needs and concerns of all affected parties.

Conclusion

The proposed amendments to the New Drugs and Clinical Trials Rules, 2019, mark a progressive step in India’s regulatory landscape. By streamlining processes and emphasizing ethical oversight, the government is paving the way for efficient and responsible clinical research. Stakeholders are encouraged to review the draft rules and provide their inputs to shape the future of drug development and clinical trials in India.

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Source: MoHFW

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