The group had approached the Supreme Court, raising concerns on clinical trials in a Public Interest Litigation in 2012
Civil society group Swasthya Adhikar Manch (SAM) has called for greater transparency in the enforcement of rules governing clinical trials and compensation for those affected by them.
The group had approached the Supreme Court, raising concerns on clinical trials in a Public Interest Litigation in 2012. They had then highlighted the absence of a robust regulatory framework governing clinical trials in India.
Following the SC’s intervention, several important reforms were introduced, including mandatory registration of Ethics Committees, strengthening of the informed consent process (including video recording), and the notification of the New Drugs and Clinical Trials Rules, 2019, the group said. These rules laid down guidelines for reporting deaths and Serious Adverse Events (SAEs) and introduced multi-layered approval mechanisms, it added.
“Despite these reforms, serious gaps in implementation and repeated violations persist,” the group alleged.
The apex court had hear the PIL earlier this week. Senior Advocate Sanjay Parikh and Advocate Abhimanyu Shrestha, representing SAM, highlighted the gaps that remain in the current regulatory framework, the note said.
According to data compiled by SAM — based on government submissions in court, RTI responses, and replies from the Ministry of Health and Family Welfare in the Rajya Sabha — “a total of 8,205 deaths and 37,711 Serious Adverse Events (SAEs) were reported between 2005 and July 2025. This amounts to 45,916 cases, averaging more than one death and over five serious adverse events every day,” the group alleged.
“It is deeply concerning that only a small proportion of affected individuals or their families have received compensation, raising serious questions about the transparency and effectiveness of the compensation mechanism,” it added.
SAM also raised concerns on Contract Research Organisations (CROs), undertaking work from multinational pharmaceutical companies. The group alleged that they were recruiting vulnerable populations without ensuring proper safeguards or compensation.
The group called for strengthening accountability and transparency in clinical trials, with strict enforcement of existing regulations; ensuring genuine informed consent and protection of participants’ rights and establishment of a “fair, timely, and transparent compensation mechanism.”
