Supreme Court Probes Clinical Trial Regulations

The Supreme Court has called on an NGO to submit detailed documentation regarding alleged inadequacies in the 2024 regulations governing clinical trials of vaccines and medicines. The request was made during a hearing of a public interest litigation (PIL) initiated by the NGO Swasthya Adhikar Manch in 2012, which accused multinational firms of conducting widespread drug trials in India.

The PIL highlights concerns over inadequate safety measures and insufficient compensation for victims, asserting that economically disadvantaged citizens are being exploited as 'guinea pigs.' Senior advocate Sanjay Parikh, representing the NGO, emphasized that there is no challenge to the New Drugs and Clinical Trials (Amendment) Rules, but rather significant gaps that require attention. Notably, around 8,000 deaths have been reported during such trials without due compensation.

In response, the Supreme Court has asked Parikh and other legal representatives to compile documentation of actions taken so far and issues with existing rules, setting April 27 for further deliberation. The Centre argues that current rules, formalized in 2019 and amended in 2024, streamline clinical trial approvals and align with global safety standards, yet doubts remain about their effectiveness in safeguarding Indian citizens.