BENGALURU: An internal audit committee commissioned to assess the quality of clinical research at HCG Hospital found that a phlebotomist—someone trained only to draw blood—was assigned the role of an “unblinded staff member” responsible for managing and mixing investigational cancer drugs in a clinical trial. This serious breach of protocol, which requires a qualified pharmacist for any drug preparation, was among several alarming lapses flagged in the audit.
The review, sources told the TNIE, came to an abrupt halt after auditors were asked to stop midway by site staff, reportedly on the instructions of Dr Sathish CT, Director of Clinical Trials at HCG. The audit was conducted by Quinary Clinical Research between February 12 and 22, 2023, with the objective of checking the functioning of HCG’s Institutional Ethics Committee (IEC) and reviewing trial-specific processes, but its findings never came to light publicly until now—surfacing amid renewed scrutiny of HCG this year.
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.
The state health department has since written to the Drug Controller General of India, asking for a full-scale probe into the conduct of trials at the hospital.
The report also found that the committee failed to notify the Central Drugs Standard Control Organisation (CDSCO) about changes in its composition, including the appointment of a new Chairperson. No appointment letter was issued by the head of the institution, and there was no formal communication of such changes. In fact, resignation letters of Ethics Committee members dating as far back as 2013 had not been archived.
Storage and access to sensitive clinical trial data were also found to be insecure. The site lacked a controlled document storage system and the records were being stored without even basic infrastructure to protect them.