Ahmedabad : A detailed investigation has uncovered how a group of doctors at VS Hospital, including an associate professor, allegedly conducted illegal clinical drug trials for four years without detection. Documents reveal that the trials were conducted in collaboration with a city-based contract research organization (CRO) and an East Asian pharmaceutical company, with no proper ethics oversight at VS Hospital after a 2019 management split.
One such trial tested the drug Deglusterol, targeting Type 2 diabetes patients. The study was titled:
A randomized, double-blind, placebo-controlled, parallel study to assess the effects of Deglusterol on fasting glucose and other cardiometabolic risk factors in patients with Type 2 diabetes mellitus.
The trial was managed via a Clinical Trial Agreement (CTA) involving the pharma sponsor, CRO, principal investigator Dr. Dhaiwat Shukla, and a site management firm. Although an ethics committee existed at SVP Hospital, there was none at VS Hospital, which was exploited to bypass regulatory approvals.
Key findings:
Dr. Shukla and eight other contracted doctors at VS Hospital were involved. Their services have since been terminated.
The CRO was responsible for data management, trial execution, and coordinating between the sponsor and local team.
The drug Deglusterol was provided free by the sponsor.
All patient data was logged on a third-party platform; the CRO retained monitoring access.
Adverse effects were to be reported to the CRO, sponsor, and an ethics committee based in Jodhpur—a questionable choice given the trial’s Ahmedabad location.
Officials say the trial lacked local ethics clearance and violated Good Clinical Practice (GCP) standards. The Ahmedabad Municipal Corporation (AMC) is continuing its investigation into the case.
