Table of Contents

Drugs and Cosmetics Third Amendment Rule 2013

This webinar was organized to discuss the requirements for registration of Ethics Committees with DCGI, and the process to be followed for the same, as laid down in Rule 122DD, Drugs & Cosmetics Act (Third Amendment) Rules, Feb 8, 2013. The following points were discussed in the webinar.

  • EC registration validity
  • Process for re-application in case of cancellation
  • Compliances to be followed by EC
  • Schedule Y Appendix VIII – Changes and Reiterated points
  • Composition requirements of EC
  • Maintenance of records by EC
  • Application procedure for EC registration to DCGI
  • Requirements of pre-screening checklists by DCGI
  • Undertaking by Ethics Committee
  • SOPs of EC

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