Ahmedabad: A team from the regional office of the Drugs Controller General of India (DCGI) made its first visit to VS Hospital on Monday and initiated a probe into allegations of illegal clinical trials there. The team also visited the Ahmedabad Municipal Corporation (AMC).
This development follows allegations involving 58 such clinical trials at VS Hospital. During their visit, the DCGI officials reportedly shared details with a senior AMC official.
The senior AMC official revealed to TOI that the inspecting DCGI team stated they “never recalled conducting routine inspections at the VS Hospital clinical trial site over the past four years.”
This comes despite the significant number of ‘unauthorised’ trials alleged to have taken place during this period. The senior AMC official further said, “We were told by the DCGI that 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.”
The SC’s intervention on April 30, prompted by a petition from the NGO Swasthya Adhikar Manch (SAM) concerning the alleged irregularities at VS Hospital, appears to have spurred the DCGI’s current action.
“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 AMC official informed TOI.
Interestingly, Rajshri Kesari, the municipal councillor who initially brought the issue to the forefront, revealed, “I was not approached by the DCGI team.”
The DCGI’s investigation is set to cover crucial aspects of the clinical trials. The AMC official outlined the scope of the probe, stating, “The DCGI inspection team will review the informed consent forms and documentation of the trial subjects and their rights and safety.” Also, the ethical oversight mechanisms employed will be examined.
“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 are likely to be scrutinised.
The DCGI’s mandate to ensure adherence to ethical and regulatory guidelines will guide their investigation. “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 DCGI checks whether there was conformity with Good Clinical Practices 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.”
