MoHFW Proposed Amendments to New Drugs and Clinical Trials Rules- 2019

The Ministry of Health and Family Welfare, Government of India, has recently published a draft notification proposing amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments, outlined in the Gazette of India on August 27, 2025, aim to streamline the regulatory framework for drug development and clinical trials in the country. Stakeholders and the public have been invited to submit objections or suggestions within 30 days of the notification’s publication.

Here’s a detailed look at the proposed changes and their implications for the pharmaceutical and clinical research sectors:

Key Highlights of the Proposed Amendments

Reduction in Approval Timelines
- The time frame for granting permissions under rules 53 and 60 has been reduced from 90 working days to 45 working days. This change is expected to expedite the approval process for clinical trials and bioavailability/bioequivalence studies, fostering faster drug development.
Online Notification for Certain Drugs
- A new provision has been introduced for the manufacture of new drugs or investigational new drugs for analytical and preclinical testing. Applicants can now submit an online notification for such drugs (excluding categories like sex hormones, cytotoxic drugs, beta-lactam antibiotics, biologics with live microorganisms, and narcotics/psychotropic drugs). Upon submission, manufacturing can commence based on the notification, eliminating the need for prior approval in these cases.
Clarifications on Rule 52
- Rule 52 has been revised to emphasize that no person shall manufacture a new drug or investigational new drug for clinical trials, bioavailability/bioequivalence studies, or other purposes without obtaining the necessary permissions from the Central Licensing Authority.

Implications for the Industry

The proposed amendments reflect the government’s commitment to fostering innovation and reducing bureaucratic delays in the drug development process. By halving the approval timelines and introducing an online notification system for certain categories of drugs, the amendments aim to:

Accelerate Research and Development: Faster approvals will enable pharmaceutical companies and research organizations to bring new drugs to market more quickly.
Enhance Ease of Doing Business: The online notification system simplifies the regulatory process, particularly for preclinical and analytical testing.
Focus on Safety: By excluding high-risk drug categories (e.g., narcotics, biologics with live microorganisms) from the notification system, the amendments maintain a balance between regulatory flexibility and safety.

How to Submit Feedback

The government has invited objections and suggestions from stakeholders and the public. Feedback can be submitted within 30 days of the notification’s publication to:

Address: Under Secretary (Drugs), Ministry of Health and Family Welfare, Room No. 545, A Wing, Nirman Bhavan, New Delhi – 110011
Email: drugsdiv-mohfw@gov.in

This is an opportunity for industry professionals, researchers, and other stakeholders to contribute to shaping the regulatory landscape for drug development in India.

Conclusion

The proposed amendments to the New Drugs and Clinical Trials Rules, 2019, mark a significant step towards modernizing India’s regulatory framework for pharmaceuticals. By reducing approval timelines and introducing streamlined processes, the government aims to create a more conducive environment for innovation while ensuring public safety. Stakeholders are encouraged to review the draft rules and provide their inputs to help refine these changes further.

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Source: MoHFW

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