How unauthorised clinical trials at Ahmedabad hospital have left many in agony
Between 2021 and 2025, over 500 people from economically weaker sections primarily from the slums of Nikol and Hatkeshwar were subject to unauthorised medical trials
Nikol ni chali, an urban slum in the eastern part of Ahmedabad, houses around 700 families, mostly belonging to Devi Pujak and Madari, who are denotified communities. While women of the slum mostly work as household maids, the men earn a livelihood by doing odd jobs.
For years, the area has served as the go-to place for picking people for clinical trials. Most families in the slum have been subjects of clinical trials for generations to earn small amounts of money.
Unauthorised trials
Between 2021 and 2025, over 500 people with poor socio-economic backgrounds primarily from the slums of Nikol and Hatkeshwar in Ahmedabad were subjected to unauthorised medical trials at the Seth Vadilal Sarabhai (VS) Hospital.
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The issue was first raised in March 2025 by Swasthya Adhikar Manch (SAM), a Gujarat-based NGO along with a local councillor with the Municipal Commissioner of the Ahmedabad Municipal Corporation (AMC).
However, the matter was then brushed aside, with Dr Manisha Patel, the medical superintendent of the hospital, claiming there were no irregularities in the clinical trials at the VS Hospital.
Judiciary intervenes
Later, multiple Opposition leaders raised the issue and SAM filed a PIL. On May 1, the apex court sought a report on the matter from the Gujarat government.
The health department formed a committee comprising the dean of the NHL Medical College, the Medical Superintendent of VS Hospital and the director of vigilance of the AMC to investigate the matter.
According to an interim report by the investigative committee, since 2021 around 58 national and international pharmaceutical companies have conducted clinical trials of their products on some 500 patients at the VS Hospital, run by the AMC. These companies tested drugs for rheumatoid arthritis, skin diseases and various vaccines.
Forged documents
“S4 Research Private Limited, a patient recruitment firm, managed to sign 25-year MoU with the VS Hospital. The firm was responsible for bringing a majority of the subjects for clinical trials at the hospital,” the report read.
It said the subjects were made to sign the Clinical Trial Agreement (CTA) by Dr Dhaivat Shukla of CBCC Global Research, an Ahmedabad-based pharma company. The signature of a VS hospital’s doctor on the CTA was also found to be forged.
“Further, no official permissions were taken and other signatures were also forged for approval process by the authorities of the S4 Research Pvt Ltd. The MoU with the hospital also turned out to be entirely bogus,” read the report.
Probe widened
The health department has widened its investigation following the revelation of an illegal clinical trial in the VS hospital. The committee will be probing clinical trials in colleges and hospitals run by the Directorate of Medical Education and Research (DMER) and the Gujarat Medical Education Research Society (GMERS).
“Rules were being violated in the clinical trials conducted by VS Hospital and that is being investigated. However, ethical clinical trials have been running in medical colleges and hospitals of DMER and GMERS. This is not an investigation but a verification. We have asked for data and details of the clinical trials to check if the records are streamlined,” said Harshad Patel, the Gujarat health secretary.
Doctors suspended
Following the investigation, Dr Devang Rana, an associate professor and expert pharmacologist, and Dr Manisha Patel, Superintendent of the VS Hospital, were suspended for misconduct and procedural violations.
Also, eight contractual doctors including Dr Yatri Patel, psychriatist, Dr Dhaivat Shukla and MD Rajvi Patel, both dermatologists, Dr Kunal Sathwara, general surgeon, Dr Shalin Shah, diabetologist, and Dr Darshil Shah and Dr Kandarp Shah, both urologists, serving at the hospital have been relieved of their duties.
Following his suspension, Rana wrote a letter to the Municipal Commissioner of AMC stating that he had been facing harassment for over a year and files related to clinical trials, important documents and even scrap material were stolen from his office.
Rana reportedly signed all the documents and contracts related to the clinical trials on behalf of all stakeholders, including investigators, sponsors, the dean and the Ethics Committee.
Ex-official speaks
Meanwhile, former medical superintendent Manisha Patel, who has been at the centre of the scam, has refuted all allegations against her.
“I have not committed any scam. Around 40 to 45 clinical trials were conducted under my tenure. Due process was followed in all of them and Rs 6 crore earned were deposited into the accounts of the VS Hospital,” Dr Patel told The Federal.
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“Normally, the income from the clinical trial is split between doctors and the hospital. But in this case, the entire amount was split between the doctors who approved the illegal trials and formed an ethics committee involving doctors from another private hospital,” said Harshad Patel.
No aid for victims
Notably, an ethics committee comprising Dr Pratik Shah, Dr Atish Shah, Dr Janak Khambholja, Dr Amit Shah, Sejal Sutaria and Meet Jhatakia practicing at Sangini Hospital, a private institute, approved the arrangement at the VS Hospital agreeing to the terms and conditions of the clinical trials.
“Approximately 500 low-income patients were subjected to unapproved clinical trials over a period of four years. People who were already ailing with various medical conditions were falsely told that government-approved medicines were unavailable and were administered unapproved medicines instead,” said Amulya Nidhi, coordinator of SAM.
“Now most of them suffer from irreparable health damages. There are seven people whose kidneys are failing and they have no money for treatment. The government has not offered any help for the victims of the trials,” adds Nidhi.
Destitute victims
Rina (name changed) was one of the residents of Nikol ni chali who was unknowingly part of two clinical trials conducted at the VS Hospital.
“We are not new to clinical trials. We undergo the process knowing there might be some health complications. Yet we do it for money. The last two clinical trials I was part of paid me enough money to repay my debt of Rs 1.5 lakh. But I have been unwell since the trials. It took a toll on my body and I was diagnosed with type A diabetes. For three years I have not been part of any trial owing to my health,” moans 29-year-old Rina.
Renal failure
“But this time, I was told there is a new medicine approved by the government that treats diabetes in young people. I trusted the information as it came from the man who always comes to our slum to recruit people for trials. I was told I just had to go to the VS Hospital to get the medicine.
“But my condition kept deteriorating. Doctors, however, assured me it takes time. Now I am bedridden with both my kidneys failing. I have a fever and body pain on most days. I can’t get up or even turn sides on the bed on my own,” shared Rina, who is one of the people who was enrolled in a clinical trial at VS Hospital without her consent.
Losing eyesight
Another patient, Kishore (name change), who has lost complete vision in his left eye and has partial vision in his right eye, was convinced to be treated for his chronic skin issue.
The 34-year-old, also a resident of Nikol ni chali, was approached by a contractor of a patient recruitment firm who assured him of a new medicine that would help his condition. “I was part of a drug trial in 2019 that gave me chronic skin issues. After the trial, my whole body itched all the time. After a while, it starts paining. It was getting unbearable so I readily agreed to the new medicine."
Human suffering
“But I started feeling dizzy after the first dose. The doctors were quite persistent that the medicine would work in due time. By the fourth month, I developed redness and swelling in my eyes. Doctors at the VS Hospital gave me an eye ointment and told me not to worry. But I eventually lost vision in the left eye. I can partially see through my right eye. When I reported this to the doctors, they told me to stop taking medicines for some time before they could start treating the eyes. But I never got any treatment,” shares Kishore who used to be a construction worker and sole earner of his family.
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Notably, among the subjects are 10 tribal people from Dang who have been subjected to trials since 2021 at the VS Hospital.
“Out of the 10, two men aged 49 and 21 died in 2023 after ailing from various complications. One of them has suffered a paralytic attack that has rendered him completely immobile,” says Nidhi.
Not paid enough
“I used to work as a sugarcane cutter. However, since the income was seasonal and I had a piling debt of around Rs 2.5 lakhs, I signed up for one clinical trial in Ahmedabad. I was told I would be required to visit VS Hospital twice a month to take the medicines and report back any symptoms. After eight months, they started to call me every week. I was told I was given the same medicines but in increased dosage. But later I learned that they administered two other medicines as part of different drug trials that I did not sign up for,” says Ravi (name changed), who got paid Rs 200 a month between March 2021 and September 2023.
“I had thought it would pay me enough to repay my debts. Instead, I was left paralysed. I cannot move or work anymore. My 15-year-old son went to work this season as a sugarcane cutter instead of me. He had to quit school to sustain our family,” complained 49-year-old Ravi.