By News Karnataka
An internal audit has revealed grave violations in clinical trial practices at HCG Hospital, Bengaluru, raising troubling questions about participant safety, research integrity, and regulatory compliance.
Commissioned to evaluate the hospital鈥檚 Institutional Ethics Committee (IEC) and trial processes, the audit鈥攃onducted by Quinary Clinical Research in February 2023鈥攗ncovered that a phlebotomist, trained only in drawing blood, was tasked with preparing and handling investigational cancer drugs鈥攁 role strictly reserved for licensed pharmacists. This breach alone represents a serious threat to patient safety and protocol integrity.
Worryingly, the audit was abruptly halted midway by site staff, reportedly under instructions from Dr. Sathish C.T., Director of Clinical Trials, effectively stalling a full assessment. The findings remained under wraps until recently, resurfacing amid an active probe initiated after the resignation of former IEC Chairperson Justice P. Krishna Bhat, who flagged widespread irregularities and conflicts of interest.
Among the red flags:
SOPs were authored by personnel without proper clinical research credentials, relying on outdated regulations replaced in 2019.
In response, the State Health Department has now written to the Drug Controller General of India, requesting a comprehensive investigation into the hospital鈥檚 trial operations.