The regulatory action covers seven Ethics Committees: Hurip Independent Bioethics Committee (Kolkata), Rational Independent Ethics Committee, Society for Promotion of Health and Environmental Sciences (New Delhi), Ethiwell Ethics Committee (Navi Mumbai), Institutional Ethics Committee, Aatman Hospital (Ahmedabad), Ethos Ethics Committee (Navi Mumbai), Dr. T. K. Pal Memorial Bioethics Committee (Kolkata), and Royal Pune Independent Ethics Committee (Pune), whose Registration Certificates have been cancelled under the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019 following the completion of the prescribed regulatory process.
The action was taken under the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, after the committees failed to meet the standards prescribed under the rules, Good Clinical Practice (GCP) guidelines, and other applicable regulatory requirements.
These inspections are conducted to assess compliance with the applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and the effectiveness of the Quality Management Systems (QMS) implemented by the Ethics Committees with the objective of ensuring the protection' of the rights,'safety. well-being , and dignity of clinical trial participants.
Based on Risk- Based Inspections of registered Ethics Committees across the country significant deficiencies and major non-compliances with the provisions of the NDCT Rules, 2019, Good Clinical Practice (GCP) guidelines and other applicable regulatory requirements were observed in certain Ethics Committees.
Following the due regulatory process, including issuance of inspection reports evaluation of the Corrective and Preventive Action (CAPA) responses submited by the concerned Ethics Committees issuance of Show Cause Notices, and grant of personal hearings, wherever applicable, CDSCO has taken appropriate regulatory action. Accordingly, the Registration Certificates of the following Ethics Committees have been canceiled under the provisions of the NDCT Rules, 2019:
| S. No. | Name of Ethics Committee | Address | RC No. | Date of Cancellation |
|---|
| 1 | M/s Hurip Independent Bioethics Committee | Ground Floor, 77/2M/1, Ibrahimpur Road, Jadavpur, Kolkata – 700032 | ECR/103/Indt/WB/2013/RR-19 | 07.07.2025 |
| 2 | Rational Independent Ethics Committee, Society for Promotion of Health and Environmental Sciences | J-36, Saket, New Delhi – 110017 | ECR/1/Indt/DL/2013/RR-19 | 07.07.2025 |
| 3 | Ethiwell Ethics Committee | Flat No. 202, Jai Omkar Apartment, Plot No. 36, Sector 20, Airoli, Navi Mumbai, Thane, Maharashtra | ECR/91/Indt/MH/2013/RR-19 | 10.11.2025 |
| 4 | Institutional Ethics Committee, Aatman Hospital | 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Ahmedabad, Gujarat – 380058 | ECR/1565/Inst/GJ/2021 | 08.11.2025 |
| 5 | Ethos Ethics Committee | Ashiv Apartment, Sector 5, Opp. Koparkhairne Station, Navi Mumbai – 400709 | ECR/139/Indt/MH/2013/RR-19 | 21.08.2025 |
| 6 | Dr. T. K. Pal Memorial Bioethics Committee | Taab Biostudy Services, 69, Ibrahimpur Road, 1st Floor, Flat No. 1A, Jadavpur, Kolkata, West Bengal – 700032 | ECR/395/Indt/WB/2025 | 27.10.2025 |
| 7 | Royal Pune Independent Ethics Committee | Office No. 13, Survey No. 18/A, Anupam Arcade, Opposite Snake Park, Pune-Satara Road, Katraj, Pune – 411046, Maharashtra | ECR/45/Indt/MH/2013/RR-24 | 04.05.2026 |
According to the CDSCO, the cancellation of the seven Registration Certificates was necessitated due to serious deficiencies and major non-compliances that adversely affected the functioning of the respective Ethics Committees and compromised their ability to discharge their responsibilities in accordance with the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, Good Clinical Practice (GCP) Guidelines, and other applicable regulatory requirements.
Beyond the enforcement action, the national drug regulator has issued a strong advisory to all registered Ethics Committees, directing them to ensure strict compliance with the NDCT Rules, 2019, CDSCO guidance documents, GCP guidelines, and all other relevant regulatory requirements.
The regulator has emphasised the need to establish and maintain robust Quality Management Systems (QMS), uphold independence, transparency, and impartiality in ethical review, maintain complete, accurate, and contemporaneous documentation, effectively identify and manage conflicts of interest, conduct timely continuing review and oversight of approved clinical trials, safeguard vulnerable participants and protect the rights, safety, and well-being of all clinical trial participants, ensure prompt review and reporting of Serious Adverse Events (SAEs), protocol deviations, and other reportable events, and fulfil all regulatory obligations under the NDCT Rules, 2019.
CDSCO stated that the notice has been issued in the interest of safeguarding the rights, safety, well-being, and dignity of clinical trial participants while strengthening the ethical and regulatory oversight of clinical research in India.
To view the official notice, click the link below:
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