India Profile Updated

March 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 Committee for Stem Cell Research (IC-SCR) Registration (see Submission Content)

Sources Added During this Update:

(Legislation) The Mental Healthcare Act, 2017 (MHA2017) (April 7, 2017)
Parliament of India

(Document) Re-Registration of Ethics Committee - Checklist for Application Submissions (IND-69) (February 8, 2013)
Central Drugs Standard Control Organization

(Webpage) SUGAM - Contact Us (IND-70) (Current as of March 24, 2022)
Central Drugs Standard Control Organization

(Webpage) Central Drugs Standard Control Organization - Public Relations Office (IND-71) (Current as of March 24, 2022)
Central Drugs Standard Control Organization

(Webpage) Institutional Committee for Stem Cell Research (IC-SCR) Registration (IND-72) (Current as of March 24, 2022)
National Apex Committee for Stem Cell Research and Therapy

Sources Revised During this Update:

(Article) India - Data Protection Overview (IND-65) (December 2021)
Chacko, Mathew and Misra, Aadya; OneTrust DataGuidance