It is my privilege to chair the esteemed and of its kind Ethics Committee (EC) in India since more than 2 years.
The EC is constituted as per International Guidelines and have highly qualified members. Each member is well
trained in ICH-GCP Guidelines and each one knows their responsibilities. We have the members from different
faculty of medicines- Allopathic, Ayurvedic, Homeopathy and Unani.
ISBEC have been audited by the sponsors and we are proud to mention that we comply with CDSCO
Guidelines and adhere to it very strictly. We not only approve the protocols but also provide some guidance in
conduct of the study due to vast experience of the members in research field. We monitor the sites too at the
time of the conduct of the study to check whether the safety of subjects is given a priority and the study
protocol is adhered to. We take matters related to Serious Adverse Event on priority and communicate to
relevant partners as per CDSCO Guidelines.
I am sure you will derive benefit by taking advantage of our collective experience in research field. |