The Ministry of Health and Family Welfare has issued a significant draft notification aimed at simplifying the administrative process for clinical trials in India. Released on February 2, 2026, this proposal seeks to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, specifically targeting the registration process for Ethics Committees.
Key Changes: Removing the "Provisional" Hurdle
The primary focus of the New Drugs and Clinical Trials (Amendment) Rules, 2026, is to eliminate the requirement for "provisional" certificates. Under the proposed changes:
- Omission of Sub-rule (3): Rule 17, sub-rule (3) of the 2019 Rules—which previously handled provisional requirements—will be entirely removed.
- Direct Final Registration: Rule 17, sub-rule (4) is being rewritten to fast-track the process. Upon receiving an application in Form CT-01, the designated authority will scrutinize the documents. If the requirements are met, the authority will grant final registration to the Ethics Committee in Form CT-03 immediately.
- Accountability: If an application is rejected, the authority must record the specific reasons for doing so in writing.
Impact on Clinical Research
By removing the middle step of provisional registration, the government aims to reduce the "red tape" associated with setting up clinical trial oversight. This move is expected to speed up the commencement of clinical trials while maintaining strict adherence to safety and ethical standards.
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Call for Public Feedback
As this is a draft notification, the Central Government is actively seeking input from stakeholders and the public.
- Timeline: Objections or suggestions must be submitted within thirty days from the date the Gazette copies were made available to the public.
- Submission Details: Feedback should be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare.
- Contact: Correspondence can be sent to Room No. 434, C Wing, Nirman Bhavan, New Delhi, or via email at drugsdiv-mohfw@gov.in.
These rules will officially come into force on the date specified by the Government during their final publication in the Official Gazette.