The Drugs Controller General of India (DCGI) has started investigations in the case involving 58 illegal clinical trials at VS Hospital, following the Supreme Court’s directive.
The trials, according to reports, were conducted without proper regulatory oversight.
The action was prompted by an April 30 petition filed by the NGO Swasthya Adhikar Manch (SAM), which led the apex court to intervene. A media house reported that according to a senior official from the Ahmedabad Municipal Corporation (AMC), the civic body has submitted its enquiry report to the DCGI. The report included details of financial transactions, actions taken against doctors involved in the alleged misconduct, and the civic body’s overall response to the controversy.
On Monday, a team from the DCGI’s regional office conducted its first inspection of VS Hospital and also visited the AMC office. During the visit, the officials reportedly told a senior AMC officer that they could not recall conducting any routine inspections at the VS Hospital trial site over the past four years—a statement that raises serious questions about regulatory oversight.
The AMC official also said that DCGI representatives mentioned they had regularly inspected SVP Hospital’s clinical trial site instead. SVP Hospital had its own Institutional Ethics Committee (IEC) and was aware of the clinical trial activities taking place there, unlike VS Hospital.
As part of its probe, the DCGI is examining whether trial protocols and documentation adhered to legal and ethical standards. AMC sources said the DCGI team is reviewing informed consent forms, documentation concerning the rights and safety of trial subjects, and the oversight mechanisms in place. One major area of concern is the use of a private ethics committee located outside the hospital premises, while the neighboring SVP Hospital had its own in-house IEC overseeing trials.
The investigation will also scrutinise study protocols, case report forms (CRFs), and source documents to verify that trial activities were consistent with approved procedures and regulatory norms. According to AMC officials, the DCGI is cross-referencing sponsor-submitted data with site-level documents to ensure data integrity and compliance with Good Clinical Practices (GCP) guidelines and the New Drugs and Clinical Trials Rules, 2019.
Despite the scale of the inquiry, some stakeholders have reportedly been left out of the process. Municipal councillor Rajshri Kesari, who initially brought the issue to light, said she had not been contacted by the DCGI team.
As the investigation unfolds, the regulatory body is under increasing pressure to explain how dozens of clinical trials may have been conducted without its knowledge or intervention for several years.
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