The Supreme Court of India permitted a petitioner to challenge the Central Government’s clinical trial rules, amid concerns over exploitation of poor citizens. Despite recent regulatory amendments aimed at improving safety and compliance, criticisms persist regarding inadequacies in protecting participants’ rights. The court emphasized trials must prioritize the citizens’ welfare over corporate interests.
New Delhi: The Supreme Court of India on Wednesday (Jan 8th) allowed a petitioner to file objections and submissions against the rules framed by the Central Government concerning clinical trials of medicines and vaccines. The court expressed concerns that such trials were often conducted in poor countries.
A bench comprising Justices Hrishikesh Roy and S V N Bhatti made the observation during the hearing of a Public Interest Litigation (PIL) filed by Swasthya Adhikar Manch, an NGO. The PIL, filed in 2012, alleged large-scale clinical drug trials in India by multinational pharmaceutical firms using poor citizens as “guinea pigs” without adequate compensation.
The Centre’s additional solicitor general, Archana Pathak Dave, informed the court that rules for new drugs and clinical trials were framed in 2019 and amended in 2024.
She stated that the New Drugs and Clinical Trials (Amendment) Rules, 2024, were introduced to streamline the approval process for clinical trials and new drugs. These amendments aimed to improve patient safety protocols and ensure compliance with global standards.
Dave also argued that the PIL had become infructuous due to these updated regulations.
Senior advocate Sanjay Parikh, appearing for Swasthya Adhikar Manch, highlighted that despite the new rules, poor citizens were still being used in trials without adequate safeguards or compensation. Parikh sought permission to file objections and submissions to address these grievances.
The court granted Parikh four weeks to submit his objections and emphasized that clinical trials in India must benefit the country’s citizens rather than serve the interests of multinational corporations.
In 2013, the Supreme Court had criticized the clinical trial norms then in place, calling them “deficient” in protecting the rights of trial participants. This led to the introduction of updated rules in 2019 and subsequent amendments in 2024.
Clinical trials in India are regulated by several frameworks, including approval from the Drugs Controller General of India. While the government claims the rules ensure safety and compliance, the ongoing concerns raised by the NGO underline the need for continued vigilance to protect vulnerable populations from exploitation.
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