CDSCO Cancels Registration of 7 Ethics Committees Over Regulatory Non-Compliance

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration certificates of seven Ethics Committees after identifying serious deficiencies and major non-compliances with the New Drugs and Clinical Trials (NDCT) Rules, 2019, Good Clinical Practice (GCP) guidelines, and other applicable regulatory requirements.

The action follows Risk-Based Inspections (RBIs) conducted by the national regulator as part of its oversight of clinical trials across India. The inspections assessed whether registered Ethics Committees comply with regulatory requirements and GCP guidelines, and evaluated the effectiveness of their Quality Management Systems (QMS) to ensure the rights, safety, well-being, and dignity of clinical trial participants are protected.

According to the regulator, the inspections uncovered significant deficiencies in the functioning of some Ethics Committees

Following the due regulatory process—which included issuance of inspection reports, evaluation of the Corrective and Preventive Action (CAPA) responses submitted by the concerned Ethics Committees, issuance of show-cause notices and grant of personal hearings where applicable—CDSCO decided to cancel the registration certificates of seven committees under the provisions of the NDCT Rules, 2019.

The cancelled Ethics Committees are:

1. Hurip Independent Bioethics Committee, Jadavpur, Kolkata.
2. Rational Independent Ethics Committee, Saket, New Delhi
3. Ethiwell Ethics Committee, Navi Mumbai, Maharashtra
4. Institutional Ethics Committee, Aatman Hospital, Ahmedabad, Gujarat
5. Ethos Ethics Committee, Navi Mumbai, Maharashtra
6. Dr. T. K. Pal Memorial Bio Ethics Committee, Jadavpur, Kolkata
7. Royal Pune Independent Ethics Committee, Pune, Maharashtra

“The cancellation of the above registration certificates has been necessitated due to serious deficiencies and major non-compliances adversely affecting the functioning of the respective Ethics Committees and their ability to discharge their responsibilities in accordance with the provisions of the NDCT Rules, 2019, Good Clinical Practice (GCP) guidelines, and other applicable regulatory requirements,” Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi said in a notice issued on Friday.

CDSCO has also directed all registered Ethics Committees to strictly comply with the provisions of the NDCT Rules, 2019, applicable CDSCO guidance documents, GCP guidelines, and other relevant regulatory requirements.

The regulator stressed that Ethics Committees should focus on:

• Establishing and maintaining a robust Quality Management System (QMS)
• Ensuring independence, transparency, and impartiality in ethical review
• Maintaining complete, accurate, and contemporaneous documentation and records
• Effective identification and management of conflicts of interest
• Timely continuing review and oversight of approved clinical trials
• Protection of vulnerable participants and safeguarding the rights, safety, and well-being of all clinical trial participants
• Timely review and reporting of Serious Adverse Events (SAEs), protocol deviations, and other reportable events
• Compliance with all applicable regulatory obligations under the NDCT Rules, 2019.

CDSCO said the regulatory action has been taken in the interest of strengthening ethical oversight of clinical research and safeguarding the rights, safety, well-being and dignity of clinical trial participants across the country.