05-07-2025
Unqualified HCG staff mixing cancer drugs, shows internal audit in Bengaluru
Among the most serious concerns was that Standard Operating Procedures (SOPs) used at the site were authored by individuals lacking clinical research qualifications. The guidelines referred to an old rulebook that had been officially replaced in 2019.
Auditors noted that key documents related to serious adverse events (SAEs) and protocol violations were also missing. There were no impact assessments, no clarity on medical management provided to affected participants, and no documentation of financial compensation, despite these being mandatory under regulatory norms. Even when SAEs were discussed in IEC meetings, the report said, there was little explanation about causality or follow-up actions. The functioning of the Ethics Committee itself was found to be severely compromised. In multiple instances, committee meetings were held without the required quorum.
These findings now come under scrutiny again as HCG faces an ongoing investigation triggered by a letter from former IEC Chairperson Justice P Krishna Bhat. In his resignation earlier this year, he flagged multiple ethical and procedural lapses, including conflict of interest and lack of independence in clinical trial oversight.
