The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of the Ethics Committee at Ahmedabad’s Aatman Hospital Institute after a risk-based inspection found violations of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
The move is part of a nationwide crackdown on ethics committees responsible for overseeing clinical trials. Along with the Ahmedabad committee, CDSCO has also cancelled the registrations of Athivel Ethics Committee and Ethos Ethics Committee in Navi Mumbai.
Ethics Committees Play Key Role in Clinical Trials
Ethics committees are responsible for reviewing and monitoring clinical trials involving human participants. They ensure that research is conducted ethically, protect the rights and safety of volunteers, and verify compliance with regulatory standards before new drugs are approved.
According to CDSCO, inspections revealed serious non-compliance with the NDCT Rules, Good Clinical Practice (GCP) guidelines and other regulatory requirements.
Three More Ethics Committees Lose Registration
The drug regulator has also cancelled the registrations of the following ethics committees:
- Dr T.K. Pal Memorial Bioethics Committee, Kolkata
- Rational Independent Ethics Committee, New Delhi
- Royal Pune Independent Ethics Committee, Pune
CDSCO has directed all ethics committees across the country to strictly follow the NDCT Rules, GCP guidelines and other applicable regulations.
Major Lapses Found During Inspection
The inspections identified several serious deficiencies, including:
- Weak quality management systems and procedural lapses
- Failure to adequately protect the rights, safety and welfare of clinical trial participants
- Inadequate ethical review of clinical trial proposals
- Lack of independence and impartiality in decision-making
- Poor transparency during the ethical review process
- Incomplete and delayed documentation
- Failure to properly identify and manage conflicts of interest
- Inadequate monitoring of ongoing clinical trials to ensure participant safety
CDSCO Calls for Stricter Compliance
The regulator has asked ethics committees to strengthen their quality management systems and ensure transparency, independence and impartiality in their reviews. It has also stressed the need for proper documentation, effective conflict-of-interest management, continuous monitoring of approved clinical trials and stronger safeguards for the rights and safety of trial participants.
The action is part of CDSCO’s broader effort to tighten oversight of clinical research and improve ethical standards in drug trials across India.