Ahmedabad: The saga on illegal clinical trials at VS Hospital is getting murkier with suspicions being raised over matters beyond the money trail.
Reliable sources rue that the investigation is mainly focusing on the crores of rupees deposited in the bank accounts of the then VS Hospital superintendent Dr Manish Patel and associate professor Dr Devang Rana, who was appointed clinical head.
"SVP Hospital had an ethics committee, while VS Hospital did not. Yet, private pharmaceutical companies chose the latter and conducted 58 clinical trials over four years. This not only points to financial misconduct, but also raises suspicion that the companies wanted to get the trials completed within a specific time and hence avoided the lengthy procedures of SVP Hospital's ethics committee. More irregularities may emerge if all documents and patient consents for the 58 trials are examined," a source said.
If VS Hospital lacked an ethics committee, suspended doctors and the clinical research organization (CRO) could use SVP Hospital's ethics committee on the same campus. This has been confirmed in a letter from Drugs Controller General of India Dr Rajeev Singh Raghuvanshi, approving a 2023 trial by an Ahmedabad-based CRO at VS Hospital. The letter states, "The ethics committee and the trial site must be within the same city or within a 50km radius."
In Jan 2019, SVP Hospital was established on VS Hospital's premises. Senior doctors from VS Hospital were gradually transferred to SVP Hospital. When the pandemic struck in 2020, VS Hospital was designated as a Covid hospital. "However, after 2021, only 500 beds were operational at VS Hospital, and due to a lack of senior doctors, most of the beds remained vacant. It was during this time that illegal clinical trials began," the source said.
The official backed this claim with data on indoor patients in VS Hospital. "In 2017-18, the hospital recorded 74,746 indoor patients, and 73,865 in 2018-19. After the new SVP Hospital started in Jan 2019, the number at VS Hospital fell with 22,080 indoor patients in 2019-20, 10,013 in 2021-22 and 9,646 in 2022-23. As the number of patients continued to decline, illegal clinical trials increased. Between 2021 and 2024, 58 illegal drug trials were conducted here," he said. There are also doubts if the trials even adhered to DCGI guidelines. " If all records, including patient names, are investigated, irregularities may be revealed," the official said.
"Did pharmaceutical companies choose VS Hospital for the trials because they saw their benefit?" the source said.