HCG's KR Unit Ethics Committee Suspended for Two Years Following Regulatory Action
The ethics committee unit at HCG Bangalore Institute of Oncology has been suspended by the Central Licensing Authority (CLA) from approving or overseeing new clinical trials and bioavailability/bioequivalence (BA/BE) studies for a period of 24 months. This action followed an order issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO).The suspension applies specifically to the KR Unit Ethics Committee at HCG Towers in Bangalore and does not extend to any other units or operations of HealthCare Global Enterprises Limited (HCG), including hospital operations or patient care. The company confirmed that it is examining the suspension order and exploring available legal remedies.
The suspension notice was received by the company on June 16, 2026.
Details regarding the action taken by the Central Licensing Authority are provided below:
| Particulars | Details |
|---|---|
| Name of the Authority | Central Licensing Authority (CLA), CDSCO, Directorate General of Health Services, Government of India acting through the Drugs Controller General (India). |
| Nature of Action | The CLA directed the HCGCentral Ethics Committee at HCG Bangalore Institute of Oncology (KR Unit) to be suspended from approving or overseeing any new clinical trial or BA/BE study. |
| Suspension Duration | 24 months from the date of receipt of the order. |
| Violations Alleged | The suspension was based on alleged failures by the KR Unit Ethics Committee under the New Drugs and Clinical Trials Rules, 2019. These allegations include failure to report Serious Adverse Events (SAEs) to the CLA/CDSCO within prescribed timelines, deficiencies in SAE causality assessments, and failing to furnish signed minutes for 2022. |
| Financial Impact | The company stated that there is no significant impact on financial operations or other activities of HealthCare Global Enterprises Limited, as the suspension is limited to the KR Unit Ethics Committee. |
The regulatory action addresses alleged failures regarding Serious Adverse Events (SAEs), including failure to report certain SAEs to CDSCO and deficiencies in oversight. The committee was also found deficient in procuring 'no conflict of interest' disclosures from its members.
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