India Updates
India Profile Updated
Feb 2, 2023 - The India profile in ClinRegs has been reviewed and updated with the following information:
New amendment to the New Drugs and Clinical Trials Rules which provides the timelines for when ethics committee registration, clinical trials, investigational product manufacturing, and active ...
India Profile Updated
Apr 28, 2022 - The India profile in ClinRegs has been updated to include an amendment to the definition of “new drug” in the New Drugs and Clinical Trials Rules. (See Scope of Assessment)
Sources Added During this Update:
(Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2022 (2022-CTRules-Amdt ...
India Profile Updated
Mar 24, 2022 - The India profile in ClinRegs has been reviewed and updated with the following information:
Requirements for obtaining consent from participants with mental illness (See Mentally Impaired)
A checklist for ethics committee re-registration (See Authorizing Body)
A link to the Institutional ...
India Profile Updated in ClinRegs
Mar 26, 2021 - The India profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include:
Expanded information on the terms of reference the Central Drugs Standard Control Organization (CDSCO) uses to constitute Subject Expert Committees which ...
India: ICMR Issues Guidelines for EC Review during COVID-19 Pandemic
May 11, 2020 - On May 6, 2020, the Indian Council of Medical Research (ICMR) posted National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic. The guidelines cover general ethical issues, review procedures for both COVID-19 related and non-COVID related ...
India Profile Updated in ClinRegs
Apr 1, 2020 - The India profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include:
Additional checklists and FAQs issued by the Central Drugs Standard Control Organization (CDSCO) to facilitate the clinical trial application ...
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