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Health ministry to do away with provisional registration of ethics committees under NDCT Rules
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Gireesh Babu, New Delhi
February 09 , 2026
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As part of the series of amendments notified or proposed under the New Drugs and Clinical Trials (NDCT) Rules, 2019 to simplify the procedures and enhance ease of doing business, the Union health ministry has proposed another amendment to do away with requirements of granting of Provisional Certificate for registration of ethics committee related to biomedical and health research.
The draft amendment proposes to omit the sub-rule (3) of Rule 17 of the NDCT Rules, which currently stipulates that on receipt of application in Form CT-01 for registration of the Ethics Committee, the authority designated shall grant provisional registration which shall remain valid for a period of two years.
Further, it also proposes to substitute the existing sub-rule (4) that “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”.
The sub-rule (1) of the Rule 17 stipulates that an Ethics Committee constituted under rule 16, shall be required to register with the authority designated by the Central Government in the ministry of health and family welfare, Department of Health Research under these rules for which an application shall be made in Form CT-01 to the said authority.
The draft amendment will be taken into consideration on or after the expiry of a period of 30 days from the date on which the copies of the Official Gazette containing the draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period will be considered by the Central government, it added.
As reported, the health ministry has recently issued a draft notification with proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, categorising the post approval changes of new drugs, both imported and manufactured in the country, based on the impact of the changes in the quality of the drug.
The new clause elaborates, "In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation etc. as the case may be, the manufacturer or his authorized agent shall inform the licensing authority in writing for such changes."
A proviso will also be added to this, to the effect that in case of any major quality change (Level I), or any moderate quality change (Level II), the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
In case of minor quality changes (Level III), the manufacturer shall implement the change without prior approval from the licensing authority (except for cases of change in shelf life of drug substance and drug product), where the change has a minimal potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
"The annual submission shall be made to licensing authority by 1st quarter of every calendar year," it added. A similar amendment has been proposed to the Rule 82, which specifies conditions of permission for manufacture of new drugs for sale or distribution.
The Ministry has, in recent days, notified various amendments to the NDCT Rules, regarding the manufacturing of small quantities of drugs intended for examination, research, or analysis purposes to reduce regulatory burden and promote Ease of Doing Business (EoDB).
These amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country, it said.
It has notified various amendments to the NDCT Rules, 2019, to ease the process of approval for manufacturing of new drug or investigational new drug for analytical and non-clinical testing, and to reduce the timeline for approval of manufacturing of new drug or investigational new drugs for tests.
In another step to expedite clinical research, the requirement of obtaining prior permission for certain categories of low-risk bioavailability/bioequivalence (BA/BE) studies has been dispensed with. Such studies may now be initiated on the basis of a simple online intimation to CDSCO, enabling faster commencement of studies, particularly for the generic pharmaceutical industry.
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