India's Supreme Court has demanded a response from the central government regarding allegations of 58 illegal clinical trials conducted at Ahmedabad's Sheth Vadilal Sarabhai (VS) Hospital over the past four years. The trials, allegedly conducted without the mandatory ethics committee approval, have raised serious concerns about regulatory compliance and patient safety.
Senior advocate Sanjay Parikh, representing the NGO Swasthya Adhikar Manch (SAM), informed a bench of Justices P.S. Narasimha and J. Bagchi that these trials violated the New Drugs and Clinical Trials Rules, 2019, which mandate ethics committee oversight for all clinical research.
Investigation Findings
According to an interim report filed by an investigation committee constituted by the Ahmedabad Municipal Commissioner, approximately 500 patients were involved in clinical trials conducted by dozens of pharmaceutical companies at VS Hospital since 2021. The municipal corporation-run hospital allegedly operated these trials without proper ethical oversight.
Deputy Municipal Commissioner Bharat Parmar was quoted in media reports stating, "No ethical committee was established according to National Medical Commission and Drug Controller of India regulations during the tenure of the then Superintendent."
Following the investigation, eight doctors have been suspended, though SAM argues this response is insufficient given the scope of the alleged violations.
Regulatory Violations
The allegations highlight potential breaches of multiple regulatory frameworks:
- New Drugs and Clinical Trials Rules, 2019
- Previous Supreme Court directives on clinical trial conduct
- Patient consent requirements
- Ethics committee registration mandates
"Despite the clear orders and directions of the Supreme Court in the case of unethical clinical trials, it is shocking that clinical trials were approved in the VS Hospital of Gujarat without a registered ethics committee. This is a violation of the Drug and Clinical Trials Rules 2019," SAM stated in a letter to health authorities.
Broader Implications
The case has significant implications for clinical research oversight in India, particularly regarding:
- Protection of vulnerable patient populations
- Enforcement of existing regulatory frameworks
- Accountability of pharmaceutical companies and investigators
- Transparency in clinical trial operations
The allegations emerged after a complaint by local municipal corporator Rajshree Kesari prompted the formation of an investigation committee. The committee's findings led to the suspension of eight doctors, but SAM contends that more comprehensive action is needed.
Calls for Further Investigation
SAM has written to multiple authorities requesting a thorough investigation, including:
- The Union Health Secretary
- The Drug Controller General of India
- Gujarat's Chief Secretary
- The Principal Secretary (Health) of Gujarat
"It is not a matter of just investigators; there should be a detailed investigation by the competent authority," SAM emphasized in their communication to officials.
The NGO is currently involved in Supreme Court case WP (civil) 33/2012, which addresses unethical clinical trials and has been ongoing for over a decade. The Supreme Court had previously issued detailed directions regarding informed consent, ethics committee registration, and other regulatory requirements.
As the case develops, it raises important questions about the effectiveness of India's clinical trial regulatory framework and the mechanisms in place to ensure patient protection in medical research.
