Unqualified staff found mixing cancer drugs at HCG

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.

- RISHITA KHANNA @Bengaluru

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 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.