Health Ministry Moves to Simplify Ethics Committee Registration Under NDCT Rules
New Delhi: The Central Government has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, seeking to remove the requirement for granting a provisional registration certificate to Ethics Committees.
The proposal has been notified through a draft notification issued by the Ministry of Health and Family Welfare on February 2, 2026.
According to the draft notification, sub-rule (3) of Rule 17 of the NDCT Rules, 2019, which provides for provisional registration of ethics committe, is proposed to be omitted. In addition, sub-rule (4) of Rule 17 is proposed to be substituted to streamline the registration process.
Under the revised framework, upon receipt of an application in Form CT-01, the designated authority will scrutinise the documents and information submitted by the applicant. If the authority is satisfied that the requirements of the NDCT Rules have been complied with, it will grant final registration to the Ethics Committee in Form CT-03. If not satisfied, the application may be rejected, with reasons to be recorded in writing.
The draft rules have been issued after consultation with the Drugs Technical Advisory Board (DTAB), as required under the Drugs and Cosmetics Act, 1940. The Ministry has invited objections and suggestions from stakeholders and the public within a period of 30 days from the date the Gazette copies are made available.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in." the draft notification added.
The draft rules stated
1. (i) These rules may be called the New Drugs and Clinical Trials (.. Amendment) Rules, 2026.(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.2. In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (3) of rule 17 shall be omitted.3. In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (4) of rule 17 shall be substituted, namely: ―“On receipt of application in Form CT-01 under sub-rule (1), the authority designated under sub-rule (1) shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03; or if not satisfied, reject the application, for reasons to be recorded in writing”.
To view the official notice, click the link below:
