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Ahmedabad, May 8, 2025:
A team from the regional office of the Drugs Controller General of India (DCGI) has initiated a formal investigation into allegations of illegal clinical trials at VS Hospital, Ahmedabad. The probe follows serious claims that 58 unauthorized clinical trials were conducted at the hospital over the past four years.
Background and Scope of Investigation
The DCGI team made its first official visit to VS Hospital on Monday, also stopping by the Ahmedabad Municipal Corporation (AMC) to gather relevant documentation and insights. According to a senior AMC official, the DCGI inspectors revealed that they had not conducted routine inspections at the VS Hospital clinical trial site during the past four years, despite the high number of alleged unauthorized trials.
In contrast, the neighboring SVP Hospital, which has its own Institutional Ethics Committee (IEC), has been subject to regular DCGI oversight. The lack of similar oversight at VS Hospital, and the use of a private ethics committee located outside the hospital campus, have raised additional questions that the DCGI investigation aims to address.
Trigger for the Probe
The current probe was reportedly prompted by a Supreme Court intervention on April 30, following a petition by the NGO Swasthya Adhikar Manch (SAM). The petition highlighted alleged irregularities and lapses in the conduct of clinical trials at VS Hospital.
In response, AMC provided the DCGI with a comprehensive enquiry committee report, detailing actions taken by the civic body, financial transactions related to the trials, and measures implemented against doctors implicated in the alleged illegal activities.
Key Areas Under Scrutiny
The DCGI’s investigation will focus on several critical aspects, including:
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Review of Informed Consent: Inspectors will examine the informed consent forms and documentation to ensure that trial subjects’ rights and safety were protected.
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Ethical Oversight: The mechanisms for ethical oversight, including the selection and role of the private ethics committee, will be closely scrutinized.
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Regulatory Compliance: The DCGI will assess whether the trials adhered to Good Clinical Practices (GCP) guidelines and the New Drugs and Clinical Trials Rules, 2019.
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Data Integrity: Study protocols, case report forms (CRFs), and source documents will be reviewed to ensure that trial activities align with approved protocols and regulatory standards. The DCGI will also compare sponsor-submitted data with site source documents to verify data integrity.
Reactions and Next Steps
Rajshri Kesari, the municipal councillor who initially brought the issue to public attention, stated that she was not approached by the DCGI team during their visit. The investigation is expected to continue over the coming weeks, with further scrutiny of documentation and interviews with key stakeholders.
The DCGI’s mandate is to ensure that all clinical trials in India are conducted ethically and in compliance with national regulations, safeguarding the rights and well-being of trial participants.
Disclaimer:
This article is based on publicly available information from ET HealthWorld as of May 8, 2025. The investigation is ongoing, and details may evolve as new information emerges. Readers are advised to consult official sources and updates for the latest developments.
