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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.

From gut pills to graphene condoms: What VS Hospital in Ahmedabad tested before splitting from SVP Hospital
From gut pills to graphene condoms: What VS Hospital in Ahmedabad tested before splitting from SVP Hospital

Time of India

time22-04-2025

  • Health
  • Time of India

From gut pills to graphene condoms: What VS Hospital in Ahmedabad tested before splitting from SVP Hospital

Ahmedabad: Over the past 15 years, hundreds of patients, ranging from tiny infants just six months old to senior citizens nearing 80, have been part of clinical trials conducted at VS Hospital. A cursory glance at the Union govt's Clinical Trial Registry, India, reveals that these medical studies, conducted since 2007, have tested everything from the efficacy of anti-depressants and digestive treatments to a new type of condom that claimed to enhance sexual pleasure using graphene-coated latex versus standard ones. "Between 2009 and 2019, several medical studies were conducted at VS Hospital. Then it separated from SVP Hospital in 2019 and became devoid of its own institutional ethics committee (IEC). SVP Hospital had one," said a senior AMC official. The earliest study in 2009 at VS Hospital tested a combination of pantoprazole and cinitapride on patients to treat acid reflux and non-ulcer stomach pain. Other multicentric trials included research on antidepressant combinations like paroxetine and clonazepam, and one that compared two different versions of mesalamine for patients with ulcerative colitis — though this one was eventually called off. In 2015, the hospital treated some patients suffering from avascular necrosis — a condition where bone tissue dies due to a lack of blood supply — with cultured bone cells grown from their own bodies (autologous adult live-cultured osteoblasts). by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Trade Bitcoin & Ethereum – No Wallet Needed! IC Markets Start Now Undo The final trial officially linked to VS Hospital happened just before its split from SVP Hospital in 2019. This unique study, led by the gynaecology department, tested whether condoms with graphene offered more pleasure than regular latex ones. It enrolled scores of participants between March 2019 and June 2020, straddling the period when VS Hospital separated from SVP Hospital. "Clinical trials were also held at VS, following the split with SVP Hospital. The latest — a Phase 4 trial on Sporlac for paediatric diarrhoea targeting participants aged 6 months to 18 years — was held this year," adds the senior AMC official.

‘Only 21 legal drug trials at SVP Hospital against 58 illegal trials at VS'
‘Only 21 legal drug trials at SVP Hospital against 58 illegal trials at VS'

Time of India

time22-04-2025

  • Health
  • Time of India

‘Only 21 legal drug trials at SVP Hospital against 58 illegal trials at VS'

Ahmedabad: A five-member investigation committee from the Ahmedabad Municipal Corporation 's vigilance department has begun investigation into the allegations of illegal clinical trials at VS Hospital. According to senior AMC officials in the know of the development, 21 authorized clinical trials were conducted at SVP hospital over the past four years, whereas more than double that – 58 illegal clinical trials – were allegedly conducted covertly at the neighbouring VS Hospital during the same period. Doctors involved in these illegal trials allegedly deposited crores of rupees into their bank accounts, sources said. Notably, since 2019, SVP Hospital and VS Hospital have been operating on the same premises. However, in Jan 2019, separate superintendents were appointed for both hospitals and senior doctors from VS Hospital were gradually transferred to SVP Hospital, while doctors were hired on contract to operate 500 beds at VS Hospital. During the pandemic, in 2020, both hospitals provided Covid treatment. The officials told TOI that it is after 2021 that illegal clinical trials began at VS Hospital after approval from a private ethics committee instead of through proper regulatory channels. These trials were conducted for private companies and Rs 17–20 crore were allegedly deposited into the doctors' personal bank accounts, said AMC sources. The investigation committee is preparing to charge Dr Manish Patel , the then superintendent of VS Hospital and Dr Devang Rana, the associate professor who was suspended after the allegations surfaced, sources told TOI. Multiple illegal clinical trials were allegedly conducted simultaneously in VS Hospital in 2021 and 2022. The Medical Education Trust managing SVP Hospital had information regarding these trials but did not take any action, senior AMC officials claimed.

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