The Supreme Court of India, on Wednesday, highlighted the prevalent practice of conducting clinical trials for medicines and vaccines in poorer countries, while allowing a petitioner to file objections against the rules set by the Centre regarding such trials. Justices Hrishikesh Roy and S V N Bhatti were responding to the submissions of the Centre’s additional solicitor general Archana Pathak Dave, who discussed the regulatory framework established in 2019 and updated in 2024.
During the proceedings, Dave explained that the New Drugs and Clinical Trials (Amendment) Rules of 2024 were designed to streamline the approval processes for clinical trials and new drugs in India, emphasizing enhancements in patient safety protocols and adherence to international standards. Despite these updates, concerns persist about the ethical dimensions of these trials.
Senior advocate Sanjay Parikh, representing the NGO Swasthya Adhikar Manch, argued that despite the regulatory updates, vulnerable populations in India were still being exploited as “guinea pigs” without adequate compensation. The NGO, which initially filed a Public Interest Litigation (PIL) in 2012, has been vocal about its concerns regarding the exploitation by multinational pharmaceutical firms conducting large-scale clinical trials in India.
Parikh expressed his intention to file detailed objections and submissions to ensure that the grievances related to the clinical trials are appropriately addressed. Conversely, Dave argued that the PIL had become outdated or infructuous since the rules had already been updated twice since the filing.
The Supreme Court granted Parikh a four-week period to submit his objections to the current regulatory framework. The discussion reflects ongoing judicial scrutiny over the ethical implementation of clinical trials in India, which must align with both national interests and the protection of participants’ rights.
This legal scrutiny traces back to earlier judicial observations where, in 2013, the Court criticized the existing norms as “deficient” in safeguarding the rights of trial subjects, prompting a significant overhaul of the clinical trial rules. The court has consistently emphasized that such trials should primarily benefit the Indian populace and not just serve the interests of international pharmaceutical giants.
