CDSCO Cancels 7 Clinical Trial Ethics Committees Over Violations
UPSC / SSC current affairs note
Why in news
India's drug regulator, CDSCO, cancelled registrations of seven Ethics Committees nationwide after inspections revealed serious violations of clinical trial rules. This action underscores regulatory crackdown on non-compliance to protect trial participants. It highlights the importance of ethical oversight in medical research.
Background
Ethics Committees review and monitor clinical trials to protect participants' rights, safety, and well-being. They must comply with the New Drugs and Clinical Trials (NDCT) Rules, 2019, and Good Clinical Practice (GCP) guidelines. CDSCO conducts risk-based inspections to ensure adherence.
Key facts
CDSCO cancelled registrations of seven Ethics Committees across India.
Inspections found serious violations of NDCT Rules, 2019, and GCP guidelines.
The committees failed to comply with regulatory norms, compromising participant safety.
Affected committees are in Delhi, Pune, Navi Mumbai, Ahmedabad, and Kolkata.
Cancellations followed evaluation of inspection reports, CAPA responses, show-cause notices, and personal hearings.
List of cancelled committees: Rational Independent Ethics Committee (Delhi), Hurip Independent Bioethics Committee (Kolkata), Dr T K Pal Memorial Bio Ethics Committee (Kolkata), Ethiwell Ethics Committee (Navi Mumbai), Ethos Ethics Committee (Navi Mumbai), Institutional Ethics Committee, Aatman Hospital (Ahmedabad), Royal Pune Independent Ethics Committee (Pune).
The action aims to ensure better adherence to regulatory standards for drug trials.
Prelims pointers
- CDSCO: Central Drugs Standard Control Organisation
- NDCT Rules, 2019: New Drugs and Clinical Trials Rules
- GCP: Good Clinical Practice guidelines
- CAPA: Corrective and Preventive Action
- Ethics Committee: oversees clinical trial participant rights and safety
Mains angles
- GS2: Role of regulatory bodies in ensuring ethical clinical trials
- GS3: Issues in health sector regulation and drug safety
- GS2: Government policies and interventions for health research