500 poor patients exploited in what was was to be 25-year trial period.
In an unprecedented scandal involving politicians, pharmaceutical companies, and a leading government hospital, a massive clinical trial scam has come to light in Gujarat. Over 500 poor patients were unknowingly subjected to unauthorised and illegal medical trials. At the heart of the controversy is an Ahmedabad-based company, S4 Research Private Limited, which signed a 25-year MoU with Vadilal Sarabhai (V S) Hospital, a major government institution.
Documents accessed by Vibes of India reveal that S4 Research Pvt. Ltd., a patient recruitment firm, managed to sign an MoU signed with V S Hospital, effective November 29, 2024. The company lists Ali Sajjad Bohara, Deepali Swarnkar, and Akshay Shah as directors. While one of their websites claims 11 employees, another lists 47 — a discrepancy the company has not clarified. We could not confirm the exact number.
The company simply stated, “We are involved in recruitment of patients and sites for clinical trials. We support pharmaceutical companies and CROs in their mission to take advantage of the patient recruitment potential and cost-saving opportunities in emerging markets with a focus on Asia.”
The MOU with a government hospital turned out to be entirely bogus. According to hospital insiders, no official permissions were taken, and signatures were forged to fabricate the approval process.
Worse still, the Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI) — both of which must be informed about such trials — were completely bypassed, a clear violation of Indian medical regulations.
With profit as the only motive, approximately 500 low-income patients were subjected to unapproved clinical trials targeting conditions such as arthritis, diabetes, and other chronic illnesses. Patients were falsely told that government medicines were unavailable and were pushed toward “new-age private medicines.”
Two such patients, Kajalben (name changed), a construction worker, and Vinodbhai (name changed), who suffers from joint pain, described how doctors strongly encouraged them to try alternative medications. Most victims were unaware they were participating in clinical research.
At least 57 companies agreed to be a part of the trial. The base company was a Korean firm, which has not been found involved in any irregularities.
A young municipal councillor, Rajashree Kesari, deserves much credit for exposing the scam. Though the irregularities were ongoing since November, a probe has now been launched. About eight doctors have been sacked from Vadilal Sarabhai (V S) Hospital, one of the most prominent government hospitals in Gujarat.
Even as a probe has been announced and customary suspensions have taken place, it is almost certain that such a massive scam could not happen without government backing.
“If a real, fair investigation takes place, many more skeletons will tumble out,” Rajashree told VOI. She emphasised that 100% of the patients subjected to the unauthorised clinical trial were poor.
Rajashree, who spent time with VOI, said: “This is a big scam. It is not just a medical scam. A big politician is making money out of this, and he should be exposed. I have been demanding a police complaint. This evening, I am going to raise the issue at the general board of the Ahmedabad Municipal Corporation. I want justice for the 500 poor people who have no idea what they have been subjected to.”
The patient stories smack of the way they were coerced in this entire operation . Kajalben (name changed), a poor labourer who works at a construction site, complained of itching. Vinodbhai (name changed), equally poor, complained of joint pain. Like hundreds of others, they were offered two options: either the government had run out of medicines, or they could try “very good quality, new-age private medicines.”
According to the patients, doctors appeared too insistent on these alternatives.
After a series of complaints and whistleblowing, a committee found that the ethics body — allegedly formed illegally — at the hospital conducted clinical trials on about 500 patients for various diseases on behalf of private pharmaceutical companies. The committee also allegedly collected lakhs of rupees for these unauthorised trials.
According to the Clinical Trial Agreement (CTA), Ahmedabad-based CBCC Global Research and Dr Dhaivat Shukla (Principal Investigator) were solely responsible for the informed consent of patients undergoing clinical trials. A doctor at VS Hospital signed the CTA that involved CBCC, VS General Hospital, and SM, an Ahmedabad-based company represented by Nishant Kumar Singh, who also handled the accounts.
It has now emerged that several government hospital signatures were forged.
Interestingly, CBCC was given this contract by Caregen Co. Limited, the official sponsor of the trial. The company is based in Gyeonggi-do, Korea. Their clinical trial brief stated: “Randomised, double-blinded, placebo-controlled parallel study to assess effects of Deglusterol on fasting glucose and other cardiometabolic risk factors with type 2 diabetic patients.”
VOI took the CTA to two established city hospitals and pharmaceutical companies in Ahmedabad, neither of which found anything wrong, unethical, or unusual. In fact, the CTA clearly mentions that the trial must comply with all applicable laws, regulations, and protocols.
It must be noted that the Korean company did not violate any laws.
The CTA also specified that patients must be given a clear explanation of the trial. It adds that the investigator must submit regular progress and ethics reports. Also, the patients must receive free treatment, medication, stay, and conveyance. Doctors must meet the directives specified in the CTA which runs across 27 pages.
There is a document dated June 26, 2023, on the letterhead of the Sangini Hospital Ethics Committee which approves the arrangement. Ironically, the agreement signed was in November 2024, but this ethics committee approval is dated June 26, 2023. It lists Dr Pratik Shah, Dr Atish Shah, Dr Janak Khambholja, Dr Amit Shah, Ms Sejal Sutaria, Mr Meet Jhatakia, and Mrs Shiklpa Dhankecha (BE Hindi), the layperson of the ethics committee, as agreeing to the terms and conditions.
VOI can confidently state that the entire ethics committee was a fraud and not constituted as per standard protocols. The committee was operating on behalf of pharmaceutical companies, not as an independent regulatory body.
If the trial was being held at the government-owned V S Hospital, why was the Sangini Hospital committee involved at all?
Dr Devang Rana, the V S Hospital doctor, has been sacked. He has made lakhs of rupees. You can see an exclusive invoice that he raised for Rs 8.73 lakhs exclusively on our website.
Meanwhile, authorities have acknowledged this as the largest unauthorised clinical trial they have encountered. Dr Devang Rana has been dismissed, and evidence, including an invoice for Rs 8.73 lakhs, is available on our website.
New superintendent Parul Shah has declined comment.
The former superintendent, Manish Shah, who was most probably involved, resigned under mysterious circumstances and has become a real estate entrepreneur. He refused to talk to VOI. However, our sources confirm that there are at least six more doctors at V S Hospital, Ahmedabad, who are involved in the scam. No action has yet been taken against them. New superintendent Parul Shah has also refused to talk to us.
VOI has decided to upload all documents for public scrutiny, and we wish public health policy advocates, lawyers, and humanitarians across the world come forward and help uncover these medical mafia practices.
Content retrieved from: https://www.vibesofindia.com/international-illegal-clinical-trial-scam-exposed-in-gujarat/.