3 days ago
After probe report on financial irregularities, all but one clinical trials cancelled at Ahmedabad Hospital
When the investigation into the alleged financial irregularities in clinical trials at an Ahmedabad-based government hospital began, 10 trials were underway at the hospital while seven, for which agreements had been signed, were yet to begin.
With the irregularities coming to light, all the clinical trials that were in their initial phases were shut down, while those that were yet to begin were cancelled, said a senior official of the Ahmedabad Municipal Corporation (AMC).
As of now, only one clinical trial is underway at the Sheth Vadilal Sarabhai General Hospital, Medical Superintendent Dr Parul Shah confirmed with The Indian Express.
Meanwhile, at least four to five doctors accused in the scam have returned the amount deposited in their bank accounts, said Dr Shah.
'We have sent the doctors notices that as per the report, we need to recover the money they received directly for the clinical trials. At least 4-5 doctors have already paid back the amount. The rest are also going to pay us back,' said Dr Shah.
When asked if the hospital would conduct more trials in the coming days, an official said, 'We have decided to not do any clinical trials at the moment till all these irregularities are sorted out.'
As reported by The Indian Express on July 1, a probe panel in Gujarat found financial irregularities in about 65 human clinical trials conducted at the hospital run by the AMC, where 15 doctors allegedly diverted at least Rs 1.87 crore directly to their personal accounts from 2021 — money that should have gone to the hospital first, according to a senior official.
It has now also been learnt that the Drugs Controller General of India (DCGI) has asked the hospital not to conduct any more trials without proper standard operating procedures and permissions.
The clinical trials that the hospital was conducting included those of drugs and formulations from 34 different pharmaceutical companies and clinical research companies (CROs), and were being managed by up to eight Site Management Organisations (SMOs). Of the 65 trials, a total of 48 had been completed, 10 were underway and seven were yet to begin, for which agreements had been signed.
However, according to hospital officials, currently, only one trial is still underway. An official from the AMC Medical Education Trust (AMCMET) said, 'We had stopped most of the clinical trials that were in their initial phases before the investigation began. Only one trial is underway and we will complete that trial in the interest of the patients. No patients have had to suffer due to the financial irregularities.'
Dr Shah said, 'The DCGI team that conducted its investigation here at the hospital said that the clinical trials themselves were conducted in a proper manner. Whatever discrepancies were there, were in the financial aspects. The trials were not compromised.'
The DCGI, when it conducted its three-day investigation in May, asked the hospital to immediately stop the trials, form an ethics committee and get it vetted by the authorities if they wanted to conduct more trials, said sources.
A total of 15 doctors were alleged to have siphoned off Rs 1.87 crore, proceeds from 58 clinical trials, into their personal bank accounts. Only Rs 10.63 lakh had been found to have been deposited in the account of the hospital. An inquiry committee found that a retired Medical Superintendent, an Associate Professor and 12 contractual doctors had been involved in the alleged scam
