Staggering toll of clinical trials, 8,205 deaths: Supreme Court seeks accountability

By A Representative

In a significant legal proceeding on April 21, 2026, the Supreme Court of India addressed ongoing concerns regarding unethical medical research during a hearing of the Public Interest Litigation filed by Swasthya Adhikar Manch against the Union of India. Presided over by Justice Pamidighantam Sri Narasimha and Justice Alok Aradhe, the Court examined the persistent regulatory gaps in the country’s clinical trial framework despite reforms introduced over the last decade.

Senior Advocate Sanjay Parikh and Advocate Abhimanyu Shrestha, representing the petitioners, argued that while the New Drugs and Clinical Trials Rules, 2019, were established following prior judicial intervention, significant lacunae remain in enforcement and compliance.

Data compiled by the Swasthya Adhikar Manch from government records and RTI responses revealed a staggering toll of 8,205 deaths and 37,711 serious adverse events reported between 2005 and July 2025, yet only a small fraction of victims or their families have received financial compensation.

The petitioners highlighted specific instances of alleged malpractice across multiple states, including the controversial rollout of the HPV vaccine that resulted in the deaths of seven adolescent girls in Andhra Pradesh and Gujarat without adequate accountability.

Further allegations of unethical conduct were brought forward concerning trials in Indore, where participants allegedly suffered 81 adverse events while doctors profited significantly, and in Bhopal, where survivors of the gas tragedy were reportedly subjected to trials resulting in 22 deaths.

In Ahmedabad and Jaipur, reports emerged of fabricated patient records and trials conducted without proper oversight from institutional ethics committees. A primary point of contention remains the recruitment of vulnerable, low-income populations by Contract Research Organizations acting for multinational firms, often without ensuring genuine prior informed consent or adequate safeguards.

The Swasthya Adhikar Manch and the Drug Trial Peedit Sangh have called for a total overhaul of the compensation mechanism and stricter enforcement of the informed consent process, noting that the mandate for video-recorded consent has been diluted in recent years.

Counsel for the petitioners urged the Court to address the remaining flaws in the 2019 Rules to protect the thousands of citizens living in poverty who are often treated as experimental subjects without their full understanding.

Taking note of these systemic failures, the Supreme Court is expected to scrutinize the existing regulatory enforcement mechanisms and the specific gaps in the New Drugs and Clinical Trials Rules during the upcoming hearings to ensure that medical research in India adheres to fundamental ethical and human rights standards.

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