The Central Drugs Standard Control Organisation (CDSCO) has cancelled seven ethics committees (ECs) after risk-based inspections revealed widespread non-compliance with clinical trial regulations and good clinical practice (GCP) guidelines. The action underscores the drug regulator's intensified oversight of clinical research in India.
Regulatory Inspections and Findings
CDSCO conducted targeted risk-based inspections of ethics committees across the country to assess adherence to the Drugs and Cosmetics Rules, 1945, and the GCP guidelines issued by the authority. The inspections focused on evaluating the committees' composition, functioning, and documentation practices. Officials found that the seven cancelled committees had failed to meet mandatory requirements, including those related to the review of trial protocols, informed consent processes, and adverse event reporting.
The regulator did not disclose the names of the affected ethics committees or the specific institutions they served, but noted that the cancellations are part of a broader effort to strengthen ethical oversight in clinical trials. Non-compliant committees were found to have submitted incomplete applications for renewal, lacked proper standard operating procedures, or had members without adequate training in clinical trial ethics.
Impact on Clinical Trials
The cancellation of these committees is expected to affect ongoing and future clinical trials that required their approval. Sponsors and investigators must now seek approval from other recognized ethics committees to continue their studies. The move aims to ensure that trial participants are protected and that data integrity is maintained.
India has been tightening its clinical trial framework after several high-profile incidents raised concerns about patient safety and regulatory compliance. The CDSCO's risk-based inspection approach allows it to target committees with higher risk profiles, thereby improving efficiency and oversight.
Regulatory Context
Under the Drugs and Cosmetics Rules, ethics committees must be registered with the CDSCO and comply with Schedule Y requirements. The regulator has the authority to cancel or suspend registrations for non-compliance. Since 2020, the CDSCO has conducted over 100 inspections of ethics committees, leading to several actions including warnings and cancellations.
This action aligns with global standards set by the International Council for Harmonisation (ICH) for GCP. The CDSCO has emphasized that all ethics committees must strictly follow the guidelines to ensure the rights and well-being of trial subjects.
