Health Commissioner for probe into allegations of unfair clinical trials

Following allegations of unfair clinical trials being conducted at the Bengaluru headquartered Healthcare Global Enterprises (HCG), a private cancer care facility, the State Health Department has written to the Drug Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO) seeking an investigation.

The letter written by State Health Commissioner K.B. Sivakumar follows allegations of unfair clinical trials made by retired judge P. Krishna Bhat, who formerly headed the Institutional Ethics Committee of HCG.

“Serious concerns have been raised over patient safety, regulatory compliance and institutional integrity at HCG regarding the conduct of various clinical trials including, unchecked conflict of interest and patient enrolment. These concerns have been red flagged by none other than the chairperson of the Institutional Ethics Committee, who has subsequently resigned. These lapses, if proven, will undermine the strict ethical principles laid down by the DCGI, Department of Health Research, Indian Council of Medical Research and global regulatory bodies like WHO, which mandate the highest standards of patient safety and ethical conduct in clinical trials,” the Commissioner’s letter stated.