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Not limited to VS? Crime branch probes alleged nexus in clinical drug trials
Not limited to VS? Crime branch probes alleged nexus in clinical drug trials

Time of India

time30-04-2025

  • Health
  • Time of India

Not limited to VS? Crime branch probes alleged nexus in clinical drug trials

Ahmedabad: The recent controversy at VS Hospital , where nine doctors were suspended over allegations of financial irregularities and illegally conducting clinical trials outside the knowledge of the hospital, may be just a tip of the iceberg, it has emerged. The incident has brought clinical drug trials across major public hospitals under the scanner. Even before the VS Hospital clinic trial scam came to light, the crime branch had been investigating the alleged exploitation of vulnerable citizens from underprivileged communities as subjects of these trials, who were paid between Rs 20,000 and Rs 40,000, top sources in the agency said. The city crime branch has prepared a dossier against the alleged medical drug trial mafia and plans to file a formal complaint soon for endangering human lives. According to crime branch officials, several clinical trial firms operating in the city, including a few pharmaceutical companies, employ "agents" who "recruit individuals who are in dire need of money," for experimental drug testing. "These agents reportedly receive 10-20% commission from the participants' payments and fees from the clinical trial companies," said a senior crime branch official. "We are also investigating allegations where the same individuals are repeatedly sent to different clinical trial agencies, resulting in serious health complications including stroke, paralysis and chronic infections among participants," the senior police official added. He also pointed out that the eastern parts of Ahmedabad, particularly Hatkeshwar and Nikol areas, have emerged as recruitment hotspots where families have reportedly participated in clinical trials across generations. Reema Solanki (name changed), a resident of Odhav who works as a domestic help, told TOI, "I was paid Rs 40,000 in instalments over four months for clinical trials at a prestigious hospital." "I was reeling under the debt of moneylenders, and I did not have any choice but to undergo clinical trials to feed my three young children," she added. A senior crime branch official said that they will shortly file an FIR for endangering human lives against the clinical trial mafia.

‘Funds diverted to personal bank a/cs of doctors, their kin'
‘Funds diverted to personal bank a/cs of doctors, their kin'

Time of India

time28-04-2025

  • Health
  • Time of India

‘Funds diverted to personal bank a/cs of doctors, their kin'

Ahmedabad: An inquiry committee constituted by the Ahmedabad Municipal Corporation (AMC) to investigate the alleged illegal clinical trials at VS Hospital uncovered another financial irregularity where crores of rupees meant for the hospital were allegedly diverted to private accounts of the doctors and their family members. The preliminary findings of the committee revealed that between 2021 and 2024, there were instances where money paid by pharmaceutical companies for 58 clinical trials was deposited directly into the personal bank accounts of Dr Devang Rana, his Hindu Undivided Family (HUF) account, and his wife Priyanka Rana's bank account instead of the hospital's coffers, alleged a senior AMC official. Investigators suspect that more accounts may also have been used for the financial misconduct . You Can Also Check: Ahmedabad AQI | Weather in Ahmedabad | Bank Holidays in Ahmedabad | Public Holidays in Ahmedabad While the doctors accused of financial irregularities claimed to deposit Rs 6 crores into VS Hospital's account, they failed to provide any evidence supporting the claim. No separate account for clinical trial funds was maintained as required by regulations, and officials have now requested details of the doctors' bank accounts for further investigation, revealed the AMC official. The alleged illegal clinical trials reportedly began in 2021 when VS Hospital was separated from NHL Medical College's ethics committee. Without any approval from the AMC, Medical Education Trust, or VS Management Board, retired superintendent Dr Manish Patel and clinical head Dr Devang Rana arbitrarily reduced the clinical trial establishment fee to just 10% compared to the standard 40% charged at SVP Hospital. This unauthorised 30% discount resulted in an estimated loss of Rs 18-20 crore to VS Hospital while making it an attractive destination for pharmaceutical companies. Between 2021 and 2024, only 21 legal clinical trials were conducted at SVP Hospital, compared to 58 illegal trials at VS Hospital. If SVP Hospital's ethics committee approval was sought, a 40% fee would have been required. To circumvent this, approval from a private ethics committee within a 50 km radius was obtained for trials at VS Hospital. The accused doctors claimed they obtained approval from a deputy municipal commissioner for the reduced fees but failed to provide any supporting documentation, added the AMC official. Investigators believe the doctors exploited loopholes in central govt clinical trial laws and DGCI guidelines to benefit pharmaceutical companies while diverting funds to their personal accounts.

Probe ignores human cost of illegal trials
Probe ignores human cost of illegal trials

Time of India

time24-04-2025

  • Health
  • Time of India

Probe ignores human cost of illegal trials

Ahmedabad: How did doctors manage to pocket money from the illegal clinical trials without the civic body's knowledge? That will be the focus of the five-member committee formed by Ahmedabad Municipal Corporation (AMC) to investigate the scandal at VS Hospital, and not how the civic-run hospital turned into a lab where gullible and mainly poor patients were treated as guinea pigs. Tired of too many ads? go ad free now It is suspected that 10 doctors allegedly pocketed a total of Rs 20 crore during the 58 trials conducted between 2021 and 2024, sources close to the development said. Amid the swirling scandal, AMC officials, surprisingly, have refrained from commenting on whether a separate committee will be constituted to probe the trial documents, but have confirmed AMC is looking into the money trail of crores of rupees into the bank accounts of former superintendent Dr Manish Patel and associate professor Dr Devang Rana and how it lost out on the crores of rupees, sources said. The probe completely overlooks whether the trials were legal under regulations laid down by the Central Drugs Standard Control Organization (CDSCO) under the Drug Controller General of India (DCGI) and if protocols were followed, they added. "The superintendent of VS Hospital has officially emailed the CDSCO and DCGI informing them about the 58 clinical trials conducted between 2021 and 2024," a senior AMC official, requesting anonymity, said. He added that the five-member committee will only investigate which officials or doctors received the funds during these trials. "We (AMC) cannot verify if the trials followed the correct protocols and were legal. Investigating that will require medical experts, which is beyond our scope. Therefore, our committee will only investigate the money trail," he added. VS Hospital did not have an ethics committee, but SVP Hospital, which is on the same campus, had one. Tired of too many ads? go ad free now Yet, private pharmaceutical companies conducted 58 trials at VS Hospital over four years, suggesting not just financial irregularities, but also potential misconduct to complete the trials within the time stipulated by the pharmaceutical companies. In its Thursday report, TOI had quoted insiders who said that irregularities will surface if documents and patient consent for all 58 trials are scrutinized. In Jan 2019, AMC established SVP Hospital 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. There are also doubts if the trials even adhered to Drugs Controller General of India guidelines. "That's why all documents are being concealed. If all records, including patient names, are investigated, irregularities in all clinical trials may be revealed," the official said.

Did pharma companies choose VS Hospital to avoid paperwork at SVP?
Did pharma companies choose VS Hospital to avoid paperwork at SVP?

Time of India

time23-04-2025

  • Health
  • Time of India

Did pharma companies choose VS Hospital to avoid paperwork at SVP?

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.

Ahmedabad civic body suspends 9 doctors over alleged irregularities in clinical trials income
Ahmedabad civic body suspends 9 doctors over alleged irregularities in clinical trials income

Time of India

time23-04-2025

  • Health
  • Time of India

Ahmedabad civic body suspends 9 doctors over alleged irregularities in clinical trials income

Ahmedabad: The Ahmedabad Municipal Corporation (AMC) has suspended nine doctors, including an associate professor of the civic body-run medical college, following allegations of irregularities in the income generated from clinical trials at a municipal hospital, officials said. Instead of forming an 'Ethics Committee' as mandated under the law, these doctors had set up their own committee and conducted clinical trials, a senior official of the hospital said. The AMC initiated an inquiry after Congress corporator Rajshree Kesari on Sunday alleged that at least three patients lost their lives at the AMC-run V S Hospital in four years due to illegal clinical trials. Kesari, a Congress corporator from Chandkheda ward in Ahmedabad, claimed that though 500 patients underwent clinical trials at the hospital in four years, the head of the clinical trial department, Dr Devang Rana and others siphoned off the entry fee amount paid by four pharma companies and did not give anything to the hospital. Gujarat Health Minister Rushikesh Patel on Monday said, "Following a preliminary probe, the AMC has suspended Rana and eight other doctors who were part of the clinical trial team at the hospital." Dr Rana, an MD, used to serve as an associate professor in the Department of Pharmacology of NHL Municipal Medical College , and was appointed as the head of clinical trials in V S Hospital in 2021. While Rana was a permanent employee, eight other doctors were hired by the AMC on contractual basis, he said. "Usually, income generated from clinical trials is divided into two parts. While one part goes to doctors, the other one goes to the hospital. In this case, we found that doctors had kept the entire amount with themselves. We have already suspended Rana and eight other doctors involved in it," minister Patel said. An inquiry is still on and further action will be taken as per the findings of the investigation, he said. Citing various documents in her possession, Kesari claimed that clinical research conducted by Rana and others led to the death of at least three patients. "I have various documents to prove the irregularities. Four companies had signed MoUs with the management of the V S Hospital to carry out clinical trials on patients. As per my knowledge, this illegal clinical research led to the death of at least three patients," she said. "As per the law, fees paid by these companies should have been divided between the doctors and VS Hospital. But in this case, not a single rupee was deposited into the hospital's bank account despite 500 patients undergoing trials," the corporator added. Since Kesari also put VS Hospital's current superintendent Dr Parul Shah in the dock, the latter claimed that Rana was given the responsibility of carrying out clinical trials by the then superintendent Dr Manish Patel. "Clinical trials at the V S Hospital started in 2021 when Dr Manish Patel was the hospital superintendent. Dr Patel had appointed Dr Devang Rana here as an expert pharmacologist and began the trials on patients. I was not involved in this exercise as I joined just six month ago," she told reporters on Monday. She claimed that clinical trials at the VS Hospital had been permanently stopped in December last year after the hospital management learnt about the irregularities. Instead of forming an official 'Ethics Committee' as mandated under the law, Rana and Patel had created their own committee of doctors and started conducting clinical trials, she said. "An internal inquiry has revealed that since 2021, Rana and his team of doctors conducted clinical trials on nearly 500 patients of the VS Hospital for 4 pharmaceutical research companies," she said, adding that around 50 types of such trials were conducted. Shah claimed that no one has approached her with a complaint of death due to a clinical trial at the hospital. She did not rule the angle of financial irregularities under Rana because despite conducting trials and collecting fees from companies as per agreements, money was not deposited into the hospital's official bank account.

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