India's Drugs Controller General (DCGI) has initiated a complete probe into 58 purportedly unauthorized clinical trials that took place at VS Hospital, a well-known government-run medical facility in Ahmedabad. The investigation was initiated by a complaint filed by Swasthya Adhikar Manch, a health rights NGO, and follows serious allegations of ethical misconduct, patient safety, and the seeming absence of institutional checks and balances.
Based on reports, a DCGI team has visited VS Hospital recently and interacted with the AMC officials to receive documents and analyze the situation in which the clinical trials had taken place. Importantly, the hospital lacked an Institutional Ethics Committee (IEC)—an obligatory body to review and clear trials—functioning at the time these studies were conducted. This lack of ethical review has sounded alarm bells regarding the integrity of the research and protection of rights of the participants.
The AMC that operates the hospital has also completed its own investigation and filed a report with the DCGI. The report indicates a number of discrepancies such as the failure to obtain informed consent from the trial participants, poor management of trial records, and unrecorded financial transactions regarding the studies. Some of the trials were jointly conducted with pharma companies, adding further doubt about conflict of interest and profiteering from patients.
Interestingly, the adjacent SVP Hospital, which is also owned by the AMC, has its own IEC and has been inspected by the DCGI on a regular basis. VS Hospital, on the other hand, has not received a DCGI inspection in more than four years, which is a cause of concern regarding regulatory loopholes and selective enforcement. [1]
The trials in question cut across a broad spectrum of therapeutic categories, although information on the precise nature of the drugs or interventions under investigation has not yet been released. What has emerged, however, is that the trials enrolled vulnerable patients, with many not realizing they were being enrolled in experimental studies. The absence of informed consent, especially, amounts to a very serious breach of ethical standards enunciated by the Indian Council of Medical Research (ICMR) and those prevailing globally. [2]
As a part of ongoing inquiry, records of patients, consent forms, financial audits, and other documents related to the trial are being scrutinized by the DCGI team. Disciplinary actions have already been initiated against a few hospital officials, although the extent of the accountability is being decided upon currently.
This event has once again sparked public and professional discussion regarding the status of clinical research ethics in India. Experts are demanding stricter regulation of trial rules, transparency of hospital research activities, and the formation of strong ethics committees in all institutions that carry out human research.
While the DCGI presses on with its investigation, the case is a harsh reminder of the dangers of complacency in the oversight of clinical trials—and the absolute necessity to put patient welfare ahead of institutional or corporate profit.
References:
1. Central Drugs Standard Control Organization. Guidance for Industry: Biologicals. Version 1.2. New Delhi: CDSCO, 2024. Accessed May 8, 2025. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/biologicals/1CDSCOGuidanceForIndustry.pdf.
2. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR, 2017. Accessed May 8, 2025. https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx.
(Input from various sources)
(Rehash/Sakshi Thakar/MSM)
