Supreme Court seeks Centre’s response on unethical clinical trials in Gujarat

By A Representative

The Supreme Court of India on Tuesday directed the Union Government to respond to serious allegations regarding unethical and illegal clinical trials conducted in Ahmedabad and other parts of the country. The directive came while hearing a Public Interest Litigation (PIL) filed by Swasthya Adhikar Manch (SAM), which exposed the exploitation of vulnerable populations in drug trials.

Senior advocate Sanjay Parikh, representing the petitioners, told the court that approximately 500 patients were subjected to clinical trials in a public hospital managed by the Ahmedabad Municipal Corporation. These trials, allegedly conducted without mandatory oversight by an Ethics Committee as required under the New Drugs and Clinical Trials Rules, 2019, involved 58 pharmaceutical companies—both national and international—since 2021.

According to the petition, private drug companies allegedly transferred Rs 17 to 20 crore into the personal accounts of doctors involved in the trials. Meanwhile, trial participants were paid meagre sums between Rs 200 to Rs 500 and reportedly received no compensation in cases of death or serious adverse effects (SAEs). Between 2005 and 2020, India recorded 34,390 cases involving clinical trial-related deaths and SAEs, including 6,500 deaths.

Activists from across the country also raised alarms. ND Jayprakash noted that survivors of the Bhopal Gas Tragedy were exploited in similar trials in Bhopal, resulting in multiple deaths and SAEs. In Indore, some doctors allegedly earned over Rs 5 crore while conducting unethical trials, with 81 adverse events reported. In Rajasthan, out of 213 clinical trials, 95 deaths were recorded, including several in Jaipur in 2018.

The Supreme Court instructed the Government to respond specifically to the affidavit filed on April 23, 2025, by Swasthya Adhikar Manch, and address multiple issues raised regarding clinical trial regulation.

Amulya Nidhi of SAM stated that the organization, in collaboration with Jan Swasthya Abhiyan India, Rajasthan Nagrik Manch, Drug Trial Peedit Sangh, and others, would continue its campaign to ensure justice for clinical trial victims.

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