A team from the regional office of the Drugs Controller General of India (DCGI) has launched its first investigation into allegations of illegal clinical trials at VS Hospital in Ahmedabad, marking a significant regulatory response to claims involving 58 unauthorized trials at the facility. The probe was initiated following Supreme Court intervention on April 30, prompted by a petition from the NGO Swasthya Adhikar Manch (SAM) concerning alleged irregularities at the hospital.
Regulatory Oversight Gaps Revealed
During their visit to VS Hospital and the Ahmedabad Municipal Corporation (AMC), DCGI officials made a startling revelation about their inspection history. According to a senior AMC official, the inspecting DCGI team stated they "never recalled conducting routine inspections at the VS Hospital clinical trial site over the past four years." This admission comes despite the significant number of unauthorized trials alleged to have taken place during this period.
The senior AMC official further disclosed that DCGI representatives explained they "never visited VS Hospital as a clinical site, but used to frequent the neighbouring SVP Hospital clinical trial site, which had its own Institutional Ethics Committee (IEC) and were aware of the subjects and drug trials being conducted there."
Comprehensive Investigation Scope
The DCGI's investigation will encompass multiple critical aspects of clinical trial conduct and compliance. As outlined by the AMC official, "The DCGI inspection team will review the informed consent forms and documentation of the trial subjects and their rights and safety." The probe will also examine the ethical oversight mechanisms employed at the facility.
A particularly significant focus of the investigation involves the hospital's choice of ethics committee arrangements. "Another crucial aspect of the investigation is the choice of a private ethics committee outside the VS Hospital campus, while neighbouring SVP Hospital had an ethics committee in place," the AMC official pointed out, indicating that the rationale and implications of this arrangement will be scrutinized.
Regulatory Compliance Assessment
The investigation will thoroughly evaluate adherence to established clinical trial standards and regulations. "The DCGI will also examine study protocols, CRFs, and source documents to ensure trial activities align with approved protocols and regulatory standards," the AMC official explained.
The regulatory body's assessment will specifically focus on compliance with current guidelines and rules. "The DCGI checks whether there was conformity with Good Clinical Practices (GCP) guidelines and the New Drugs and Clinical Trials Rules, 2019. Also, it compares sponsor-submitted data with site source documents to ensure data integrity, especially during post-trial or for-cause inspections."
Institutional Response and Documentation
The AMC has provided comprehensive documentation to support the investigation. "We supplied a copy of our enquiry committee report to the DCGI, including the action taken by the civic body, the details of the financial transactions, and the action taken against doctors who participated in the alleged illegal trials," the senior AMC official informed reporters.
Notably, Rajshri Kesari, the municipal councillor who initially brought the issue to public attention, revealed that she "was not approached by the DCGI team" during their investigation activities.
The DCGI's mandate to ensure adherence to ethical and regulatory guidelines will guide their comprehensive investigation into the alleged violations at VS Hospital, with particular attention to patient safety, informed consent procedures, and compliance with established clinical trial protocols.
