This presentation was discussed during workshop on ‘Recent changes in the regulatory scenario of India, with respect to Serious Adverse Events, Compensation and Ethics Committees’ Registrations’ on 10th April 2013. This workshop was organized by Auriga Research Ltd and SenseCR in collaboration with Jamia Hamdard Deemed University, New Delhi. The workshop is designed to have discussion on all the recent amendments to Schedule Y released by the Ministry of Health and Family Welfare in Jan 2013 and Feb 2013 regarding SAE reporting, compensation to be provided to subjects, and Ethics Committees’ registrations; along with case studies and discussion of various scenarios for better understanding.
The presentation covers the requirements for registration of Ethics Committees with DCGI along with challenges after introduction of 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