A team from the regional office of the Drugs Controller General of India (DCGI) began an investigation into suspected unauthorized clinical trials at VS Hospital in Ahmedabad on April 5. As part of their probe, the team also visited the Ahmedabad Municipal Corporation (AMC).
This inquiry follows serious allegations that 58 unapproved clinical trials may have been conducted at the hospital. During their visit, DCGI officials reportedly shared information with a senior AMC officer, who disclosed to TOI that the DCGI team admitted they hadn’t performed routine inspections at the VS Hospital site in the past four years.
Despite the high number of allegedly illegal trials, the DCGI had previously only inspected the nearby SVP Hospital, which had its own Institutional Ethics Committee (IEC) and regularly conducted approved trials. The DCGI was reportedly unaware of the activities at VS Hospital until the issue was recently brought to national attention.
The Supreme Court’s involvement on April 30 prompted by a petition filed by the NGO Swasthya Adhikar Manch (SAM) appears to have catalyzed the DCGI’s action. In response, the AMC provided the DCGI with a copy of its internal investigation report. This included records of financial transactions, disciplinary measures against the involved doctors, and other details related to the alleged violations.
Notably, Rajshri Kesari, the municipal councillor who originally raised concerns about the trials, stated that she had not been contacted by the DCGI team during their visit.
According to the AMC official, the DCGI’s inspection will examine several critical aspects of the trials, including how informed consent was obtained, whether participants’ rights and safety were upheld, and what kind of ethical oversight was used. A key issue is the hospital’s reliance on a private ethics committee located off-campus, despite the nearby SVP Hospital having its own in-house ethics committee. Investigators are expected to assess the reasoning and consequences of this decision.
The DCGI will also verify that all clinical trial practices complied with ethical standards and legal regulations, such as Good Clinical Practices (GCP) guidelines and the New Drugs and Clinical Trials Rules, 2019. The team will review trial protocols, case report forms (CRFs), and original medical records to ensure that trial data was collected properly and matches what sponsors submitted especially in cases of follow-up audits or targeted inspections.
