The Union health ministry will soon rectify Form CT-03 under the New Drugs and Clinical Trials (NDCT) Rules, 2019 to include Department of Health Research (DHR) as the sole regulatory authority of Ethics Committees (ECs) for Biomedical and Health Research.
The Union health ministry observed that the Form CT-03 contains some apparent inconsistencies attributable perhaps to typing or printing errors. Statements depicting these errors suggested replacements with justification as proposed by DHR.
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The issue was also deliberated at the Drugs Technical Advisory Board (DTAB) meet based on the representation forwarded by DHR that NDCT Rules, 2019 has been notified by the Union health ministry through a gazette notification dated March 19, 2019 wherein Chapter IV deals with ECs for Biomedical and Health Research.
As per Rule 17(1) of the NDCT Rules, such EC shall be required to register with the authority designated by the DHR. Accordingly, “National Ethics Committee Registry for Biomedical Research” (NECRBHR) has been set up at DHR to conduct online the entire process for registration of such ECs.
The words ‘Regulation of’ do not appear to make any sense here and appear to be by way of printing error. It may be mentioned that in Form CT 02 applicable to CDSCO this has been correctly given.
As per Rule 3, the Drugs Controller, India appointed by the Central Government in the Union health ministry shall be the Central Licensing Authority (CLA) for the purpose of the NDCT Rules and this Authority is for ethics committees in relation to clinical trial studies and new drugs only and not for granting registration of ECs for medical and health research.
EC registration for biomedical and health research is to be done by the authority designated for the purpose by DHR.
The above amendments were also deliberated in the 59th Drugs Consultative committee (DCC) meeting held on March 02, 2021 and the DCC agreed for the proposed amendments.
DTAB deliberated the matter and agreed to the recommendations of the 59th DCC and recommended to amend the NDCT Rules, 2019 accordingly.
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