Instead of confronting the ethical violations at VS Hospital—where poor and unsuspecting patients were reportedly exploited for illegal clinical trials—the Ahmedabad Municipal Corporation (AMC) has chosen to zero in solely on the financial aspect of the scandal. A five-member committee has been formed not to investigate how a civic-run hospital was reduced to a testing ground for unauthorised trials, but merely to trace how doctors managed to siphon off crores without triggering alarms within the system.
Swasthya Adhikar Manch, a non-profit organisation in India which advocates safety in clinical trials, has also questioned the AMC investigating committee’s inquiry process. Amulya Nidhi of Swasthya Adhikar Manch, a petitioner in Supreme Court Civil Writ Petition No. 33 of 2012, which addresses clinical trial misconduct, has said that by excluding the subjects from the investigation, the committee is essentially admitting that patient safety and regulatory compliance aren’t priorities.
The New Drugs and Clinical Trials Rules, 2019, stipulate that every trial site must have an independent ethics committee (EC) appointed by the institution’s head—not by the pharmaceutical sponsor. Yet, when AMC’s committee reviewed clinical trials conducted at VS Hospital between 2022 and 2024—trials that were officially registered with the Clinical Trial Registry of India—it merely listed new approvals, without examining whether these trials were carried out under legal and ethical conditions.
Meanwhile, a national daily has reported that as many as 10 doctors are suspected of having illegally generated wealth for around Rs 20 crores through the 58 unauthorised clinical trials conducted between 2021 and 2024. Yet AMC officials remain tight-lipped about whether a broader probe will be launched to scrutinise the actual trial records or examine the gross misconduct inflicted on vulnerable patients. What they have confirmed, the daily has reported, is that the investigation currently focuses on following the money trail—specifically the flow of funds into the bank accounts of former superintendent Dr Manish Patel and associate professor Dr Devang Rana—and on understanding how the civic body allowed such massive financial leakage to occur under its nose.
The ongoing probe glaringly sidesteps a fundamental question: were the 58 clinical trials conducted at VS Hospital even legal under the guidelines laid down by the Central Drugs Standard Control Organization (CDSCO) and the Drug Controller General of India (DCGI)? There is no serious attempt to determine whether regulatory protocols were adhered to—a glaring omission that raises alarming concerns about the integrity of the entire investigation.
Shockingly, VS Hospital, where the trials took place, lacked an institutional ethics committee—a basic legal requirement. However, SVP Hospital, located on the same campus, did have one. Despite this, private pharmaceutical companies went ahead and carried out dozens of trials at VS over a span of four years. This not only points to financial irregularities, but also suggests a deliberate effort to circumvent ethical oversight to fast-track trials and meet deadlines imposed by pharma sponsors.
According to insiders, serious violations—ranging from lack of proper documentation to inadequate or manipulated patient consent—are likely to be unearthed if the records of all 58 trials are properly scrutinised. The issue is further muddled by the administrative overlap: in January 2019, AMC established SVP Hospital on the premises of VS Hospital and began transferring senior doctors from VS to SVP. This shift in personnel may have allowed questionable activities at VS to go unchecked, while cloaking them in the credibility of the newer institution.
