The unauthorised and unethical clinical trials on hundreds of unsuspecting patients at Ahmedabad’s VS Hospital strikes at the core of public trust in the healthcare system. As citizen protests intensify, Swasthya Adhikar Manch, a non-profit organisation in India which advocates safety in clinical trials, has demanded immediate, widespread action to nab all the responsible parties accountable for this scam of monumental proportions.
In a letter to the Chief Secretary and the Principal Secretary of the Ministry of Health and Family Welfare, Government of Gujarat, it has said that a comprehensive investigation into the matter is necessary to restore integrity of medical research in the state. The organisation has also highlighted that a case on this issue has been pending in the Supreme Court of India, where Swasthya Adhikar Manch has been advocating for ethical oversight in clinical research for the past 15 years.
According to a recent interim report by an investigation committee formed by the Ahmedabad Municipal Commissioner, approximately 500 patients at VS Hospital were subjected to clinical trials by 58 national and international pharmaceutical companies since 2021. Of particular concern, the institution has highlighted, is the reported Phase II trial. The trials were conducted without an ethical review committee in place, which the National Medical Commission and the Drug Controller General of India (DCGI) mandates.
The letter mentions that deputy Municipal Commissioner Bharat Parmar confirmed that no ethical committee was in place during the tenure of the then hospital superintendent, directly violating guidelines under the Drugs and Cosmetic Act and orders issued by the Honourable Supreme Court of India in WP (Civil) 33/2012. These include detailed directives on informed consent, ethics committee registration, and other regulatory safeguards.
Further, Swasthya Adhikar Manch’s report alludes to the way pharmaceutical companies compensated patients between Rs 200 and Rs 500 per trial, with higher sums reportedly offered by larger companies. Moreover, financial irregularities were found: companies conducted trials without providing any financial support to the hospital itself.
Vibes of India had reported that at the heart of the operation is Ahmedabad-based S4 Research Private Limited, which managed to secure a 25-year Memorandum of Understanding (MoU) with VS Hospital, signed on November 29, 2024 — an agreement now revealed to be entirely fraudulent. According to hospital insiders, the MoU was executed without any official permission, with forged signatures used to fabricate the approval process.
Under the guise of this sham agreement, over 500 low-income patients were subjected to unauthorised and illegal clinical trials, with regulatory bodies like the Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI) completely bypassed. This calculated abuse of public healthcare infrastructure, driven purely by profit, has left patients misled, unprotected, and used as human subjects without consent — while whistleblowers now warn that this is just the surface of a far deeper, politically shielded conspiracy.
Prompted by a complaint from municipal corporator Rajshree Kesari, an investigation committee was formed, and eight doctors have since been suspended. Swasthya Adhikar Manch is not convinced that this response is adequate enough. Demanding a high-level inquiry involving all stakeholders — including regulators, sponsors, and investigators — it has questioned how such trials were approved in the absence of an ethics committee.
To reinforce the point, the organisation has referred to Rajya Sabha Question No. 216, which states that 1,517 clinical trials were conducted in Gujarat between 2015 and 2018. As many as 133 ethics committees were registered with the CDSCO during that period. There are currently 50 clinical trial centres in Gujarat, all of which, the organisation believes, must be evaluated for compliance with regulatory norms and ethical guidelines.
Swasthya Adhikar Manch and Jan Swasthya Abhiyan’s demand:
-A full investigation by the Government of Gujarat into all stakeholders involved, and a detailed audit of clinical trials registered in the state over the last 10 years — including completed and ongoing trials.
-An inquiry into the procedures followed by institutions, hospitals, and investigators conducting these trials.
-Disclosure of how many institutions have had their Ethics Committees officially registered over the past decade.
-Data on deaths and Serious Adverse Events (SAEs) linked to clinical trials in the last 10 years.
-Information on how many patients have been compensated as a result.
Swasthya Adhikar Manch believes this is a serious violation of medical ethics and public confidence rather than just an administrative oversight. It has called on the state government to act swiftly and openly in order to protect the integrity of clinical research in Gujarat and to guarantee justice for the impacted patients.
