Preparing for central drugs standard control organization ethics committee inspections in India: A review of regulatory expectations and readiness strategies.

Abstract

The Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and clinical trials in India, recently issued a comprehensive inspection checklist for ethics committees (ECs), dated 29 May 2025. This checklist aligns with the New Drugs and Clinical Trial Rules, 2019, and Indian Good Clinical Practice guidelines. Its release marks a significant step toward the standardization and accountability of ECs involved in clinical research. This review article critically examines the checklist and outlines strategies by which ECs in India can strengthen their structure, function, and preparedness in anticipation of CDSCO inspections.