After South First’s report, Karnataka’s Health Department wrote to the Drug Controller General of India, seeking an urgent investigation into alleged irregularities in the functioning of the ethics committee and clinical trials at HCG.
Published Jul 02, 2025 | 8:17 PM ⚊ Updated Jul 02, 2025 | 8:17 PM
Referencing the South First report, the CDSCO and the Karnataka Drug Administration have ordered an inspection.
Synopsis: South First‘s earlier report was based on a letter by Justice P Krishna Bhat (Retd) to the hospital’s management. As Chairperson of the Institutional Ethics Committee at HCG, he had raised serious concerns about regulatory lapses, patient safety risks, and violations of global ethical norms in clinical trials conducted at the premier cancer hospital.
The Karnataka Food Safety and Drug Administration (FSDA) and the Union Health and Family welfare ministry’s Central Drugs Standard Control Organisation (CDSCO) have initiated a formal inspection of the ethics committees of all units of HealthCare Global (HCG) Enterprises.
The inspection follows a South First exposé on 29 June about alleged irregularities of the Bengaluru-headquartered hospital’s ethics committee. After South First‘s report, “Red flag raised over clinical trials at HCG; patient safety, ethical practice at stake“, Karnataka’s Health Department wrote to the Drug Controller General of India (DCGI), seeking an urgent investigation into alleged irregularities in the functioning of the ethics committee and clinical trials at HCG.
South First‘s earlier report was based on a letter by Justice P Krishna Bhat (Retd) to the hospital’s management. As Chairperson of the Institutional Ethics Committee at HCG, he had raised serious concerns about regulatory lapses, patient safety risks, and violations of global ethical norms in clinical trials conducted at the premier cancer hospital.
In a letter dated 1 July, K Srinivas, Commissioner of the Food Safety and Drug Administration, Karnataka, wrote to the DCGI, citing the South First report and attaching Justice Bhat’s letter.
“The report has highlighted potential violations that may compromise patient safety, regulatory compliance, and institutional integrity,” wrote the Commissioner, requesting an immediate investigation into the matter.
Related: Karnataka government seeks DCGI probe into HCG clinical trial row
Minister asks for detailed report
On Tuesday under the instructions of Karnataka Health Minister Dinesh Gundu Rao, a letter was sent to the DCGI, and CDSCO seeking a detailed investigation into the allegations.
The CDSO’s letter.
Meanwhile, the CDSCO — the apex body under the Directorate General of Health Services — issued an order to its Bengaluru Zonal Office, stating: “The inspections of the Ethics Committees is planned in the Month of July 2025. The purpose of these inspections is to assess the status of compliance of the Ethics Committees formed under New Drugs and Clinical Trials Rules, 2019 as per risk-based approach.”
The letter also mentioned that “a checklist is available in this regard on the CDSCO website and that shall be utilised for uniformity in inspections and reporting.”
The Drug Controller General of India, Dr Rajeev Singh Raghuvanshi, has directed: “The duly filled in checklist, inspection report and classification of observations (critical, major and others) shall be forwarded by the zonal/sub-zonal heads of CDSCO, for necessary action under intimation to this office on email.”
He also asked that “the zonal/sub-zonal heads nominate a subject expert and Drugs Inspector or Assistant Drugs Controller from their offices to conduct the inspections.”
Accordingly, inspections have been scheduled for 3 and 4 July. Following this directive, Rajshekhar, Deputy Drug Controller of the CDSCO Zonal Office, has deputed two officials — along with officers from CDSCO headquarters in New Delhi and a subject expert — to inspect HCG’s Institutional and Independent Ethics Committees on the scheduled dates.
(Edited by Majnu Babu).
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