21-04-2025
Documents reveal modus operandi of illegal clinical trials at VS Hospital
Ahmedabad: How did a team of contracted doctors, along with an associate professor, collude with a city-based firm to conduct allegedly
illegal clinical trials
at VS Hospital, which remained undetected for four years?
Fresh documents, including the clinical trial agreement (CTA) for a drug trial involving Deglusterol for an east Asian pharma company, accessed by the investigating committee, provides a clear picture.
Documents accessed by TOI reveal that one such clinical trial 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" under protocol number CG-D-P02.
"Protocol numbers for drug trials are assigned by the Central Drugs Standard Control Organization (CDSCO)," said a senior AMC official.
"The doctors knew that an ethics committee was formed at SVP Hospital but not at VS Hospital after the 2019 split in the management. Dr Devang Rana and eight contracted doctors exploited this gap for execution," a committee member alleged.
The trial was structured through a CTA involving the sponsor, an east Asian pharma company, a city-based contract research organization (CRO), principal investigator Dr Dhaiwat Shukla, VS General Hospital (the trial site), and a site management organization based out of Jagatpur.
"Shukla was among the eight contracted doctors whose services were terminated in this alleged drug trial case," says
The pharma firm, as the sponsor, supplied Deglusterol free of cost and delegated operational control to the city based CRO.
"The CRO's responsibilities included overseeing trial execution, monitoring data collection, managing communication with the ethics committee and coordinating financial transactions with the investigator and institution," said a senior AMC official.
He added, "The CRO entered into direct agreements with Dr Shukla at VS General Hospital. Dr Shukla was tasked with ensuring compliance with Good Clinical Practice (GCP) guidelines. He was responsible for submitting the trial protocol, the final CTA, insurance documents and CTRI registration to the Jodhpur -based hospital's ethics committee — designated as the approving body stated the CTA agreement."
"Once enrolled, patients were administered the investigational drug in accordance with the protocol. Data related to each subject, including medical notes and trial progress, was entered into a third-party platform, with the CRO maintaining monitoring rights.
The investigational drug was stored, handled and administered under the supervision of the principal investigator, and any adverse reactions were to be reported to the CRO, the sponsor and the ethics committee," the AMC official said.
