Ethics Committee of Healthcare Global Enterprises Limited Suspended from Clinical Trial Approvals for 24 Months
Healthcare Global Enterprises Limited (HCG) has been directed by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), to suspend one of its operational ethics committees. The order mandates that the KR Unit Ethics Committee of HCG Bangalore Institute of Oncology cannot approve or oversee any new clinical trial or bioavailability/bioequivalence study for a period of 24 months from the date of receiving the directive.The suspension applies strictly to the KR Unit Ethics Committee and does not affect other operations, hospital activities, patient care, or other ethics committees within the company.
According to details released, the Central Licensing Authority (CLA) at CDSCO issued the order following after reviewing alleged failures by the committee under the New Drugs and Clinical Trials Rules, 2019.
Allegations Leading to Suspension
The suspension order cited several alleged violations committed by the KR Unit Ethics Committee. These include:- Failure to report Serious Adverse Events (SAEs) to the CLA/CDSCO within prescribed timelines.
- Failure to report certain SAEs to CDSCO.
- Failure to provide details regarding the SAE review sub-committee.
- Failure to furnish evidence of timely intimation of change in Chairperson of committee.
- Lack of submission of signed minutes of meetings for the year 2022.
- Failure to procure 'no conflict of interest' disclosures from members of the KR Unit Ethics Committee.
- Deficiencies in SAE causality assessments and participant safety oversight.
Operational Impact Assessment
Regarding the consequences, the company stated that based on its current assessment, there is no significant impact of the suspension order on financial operations or other activities of Healthcare Global Enterprises Limited. The decision was limited to the specific committee, and the company is currently examining the suspension order alongside available legal remedies.HCG Stock Price Movement
On Wednesday, shares of Healthcare Global Enterprises Limited edged higher, settling at ₹626.6 after gaining 0.84% in trading. The equity movement was supported by a recorded volume of 71,239 shares during the session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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