A five-member investigation committee from the Ahmedabad Municipal Corporation (AMC)’s vigilance department has begun probing allegations of illegal clinical trials at VS Hospital. According to senior AMC officials who didn’t want to be named, while SVP Hospital conducted 21 authorised clinical trials over the past four years, a staggering 58 unauthorised trials were allegedly carried out covertly at the adjoining VS Hospital during the same period.
A national daily has reported that these unapproved trials reportedly generated between Rs 17–20 crore, allegedly deposited into the personal accounts of doctors involved.
Since 2019, VS and SVP Hospitals have shared the same premises, but were administratively separated that year. Senior doctors from VS Hospital were allegedly moved to SVP, while contract-based medical staff were brought in to manage the 500-bed VS Hospital. During the pandemic in 2020, both hospitals provided COVID-19 care. However, it was only after 2021 that the alleged illegal trials began, approved not through official regulatory channels but via a private ethics committee, bypassing standard oversight.
Attributing sources, the daily reported that the AMC’s investigation is preparing to charge Dr Manish Patel, the then superintendent of VS Hospital, and Dr Devang Rana, an associate professor who was suspended following the emergence of these allegations. Multiple illegal trials were allegedly conducted simultaneously in 2021 and 2022, and though the Medical Education Trust managing SVP Hospital was aware, it reportedly took no action.
The probe also reveals a troubling history. According to the media house, over the past 15 years, scores of patients—ranging from six-month-old infants to elderly individuals nearing 80—have participated in clinical trials at VS Hospital. A glance at the Union government’s Clinical Trial Registry, India, shows a range of studies conducted since 2007, from testing antidepressant combinations and digestive treatments to evaluating a new type of condom that claimed to enhance sexual pleasure through graphene-coated latex.
One of the earliest trials, conducted in 2009, tested a combination of pantoprazole and cinitapride to treat acid reflux and non-ulcer pain. Other multicentric studies examined the effects of paroxetine and clonazepam on depression, and compared different formulations of mesalamine for ulcerative colitis, though the latter was eventually called off.
In 2015, the hospital experimented with cultured bone cells—grown from patients’ own bodies—to treat avascular necrosis, a condition caused by restricted blood flow to bone tissue. The final officially registered trial linked to VS Hospital occurred just before its 2019 split from SVP, when the gynaecology department led a study comparing graphene and standard latex condoms, with participants enrolled between March 2019 and June 2020.
Following the administrative separation, VS Hospital was left without its own institutional ethics committee (IEC), unlike SVP, which retained one. A senior AMC official noted that this absence of institutional oversight may have created a regulatory gap that allowed unauthorized trials to proceed unchecked.
Most recently, a Phase 4 trial of Sporlac, targeting pediatric diarrhoea in patients aged six months to 18 years, was reportedly conducted at VS Hospital earlier this year—underscoring the continuing need for tighter oversight and accountability.
HEIGHT OF THE MATTER
Since ending its association with SVP Hospital six years ago, VS Hospital has held trials spanning a broad range of treatments.
- Four years ago, a Phase 3 trial tested a topical spray combining calcipotriol and betamethasone dipropionate for treating mild to moderate psoriasis, specifically targeting affected areas like the scalp and groin. The study enrolled 294 participants across India, aged between 18 and 99.
- Another Phase 3 study, this time in 2022, turned its focus to moderate to severe atopic dermatitis. Researchers evaluated the efficacy of tacrolimus 0.03% ointment in a group of 354 Indian adults aged 18 to 65.
- That same year, a Phase 3 Ayurveda-based trial explored the effects of Guduchyadi tablets in managing mild Covid-19 cases. The aim was to reduce hospitalisation or prevent death, and the study enrolled 750 Indian participants between 18 and 70 years.
- Meanwhile, in the area of diabetes care, a Phase 4 single-arm study assessed the safety profile of dulaglutide, a once-weekly injectable drug for Type 2 diabetes. This trial involved 200 Indian patients ranging in age from 18 to 99.
- This year brings another significant study. A Phase 4 randomised, parallel-group trial is underway to examine the safety and effectiveness of Sporlac, a probiotic treatment for acute diarrhea. This trial targets 300 children across India, aged 6 months to 18 years.
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