Typically, an EC should consist of a minimum of 7 members from diverse backgrounds, including medical professionals, subject matter experts, legal experts, social scientists, and representatives from the community, lay persons. At least 50% of the members should be non-affiliated with the institute. The Head of the Institution should designate the Chairperson of EC, who should not be associated with the institute; the Member Secretary should be associated with the institute.

All the team members possess the necessary qualifications, experience, expertise and orientation towards bioethics. All the members on the committee should be trained in Good Clinical Practices and the prevailing regulations.

The Institutional Head should be responsible for convening a meeting of the Board of Directors of the Institute to resolve for the constitution of such ECs.

The documented Board Resolution is obtained and that is submitted as one of the documents required for EC Registration. Head of the Institution where the Ethics Committee is to be set up, cannot be part of the EC and acts as the appellate body in case of any dispute.

Preparation of Registration Documentation: Prepare the required documentation as mentioned for the CDSCO and DHR in NDCTR-2019. This mainly includes SOPs (Standard Operating Procedures) for Constitution of the EC, Roles and Responsibilities of EC Members, Terms of References, Training of EC Members, Procedure for Ethical Review of Research Proposals , Periodic Monitoring and Review of Conduct of Research, Ethical Review of Research on Vulnerable Population, Conflict of Interest of Members, Protecting and Safeguarding the Rights and Well-being of the Research Participants, Compensation for Trial Related Injuries and Death, Processing the Safety Reporting from Studies, Ensuring Training and Qualification of the Investigators and suitability for the research proposal. Handling Review and Approval of Amended Documents and CVs of all the members and their training Certificates. All members should provide confidentiality disclosure agreement for keeping the proposals confidential.

Submission to CDSCO/DHR: Once all the documentation is ready, an account in the online portal for submission needs to be created (Sugam portal for CDSCO and naitik.gov for DHR). The CT-01 or form CT-03 should be completed. The system generated undertakings and forms should be downloaded and signed by the Head of the Institution. The checklist of the documents will appear on the portal and the documents must be uploaded for all the checklists. The application can then be submitted.

Follow Up and Respond to Queries: After submitting the application, maintain regular communication with the regulatory authorities to track the progress of your application. It usually takes 45 working days for CDSCO and 60 working days for DHR to respond to the application. When queries are raised, respond promptly to any requests for additional information or clarification.

After the registration is granted, it is valid for 5 years. In case of any changes to the EC constitution, CDSCO and DHR should be notified within 30 days of the appointment of the new member.

Compliance with Regulations: The EC should comply with all the conditions of the Registration and should always be inspection ready. Record all the work done by the EC. All the proposals reviewed and rejected, minutes of the meeting safety reports processed and personnel records of the EC members should be retained for at least 5 years. Once registered, continuously monitor and adhere to the regulations set by CDSCO and DHR. Stay updated with any changes in guidelines or requirements and make necessary modifications to EC functioning.

Renewal and Reporting: Once EC is registered the registration is valid for 5 years, the application for renewal of registration should be filed 90 prior to the expiry of the validity to keep the EC functioning without any break.

By following the abovementioned steps, the EC Registration process can be done and maintained with ease and continuity.