Supreme Court Scrutinizes Clinical Trials Amidst Ethical Concerns

The Supreme Court has allowed submissions against rules by the Centre concerning clinical trials in poor countries. The decision follows claims by NGO Swasthya Adhikar Manch about inadequate compensation for Indian citizens used in clinical drug trials. Amendments aim to improve patient safety and compliance.

In a critical move, the Supreme Court has permitted a petitioner to file objections against the rules established by the Centre related to clinical trials in impoverished nations. This decision comes amidst allegations by NGO Swasthya Adhikar Manch, represented by senior advocate Sanjay Parikh, concerning inadequate compensation for Indian citizens purportedly used as 'guinea pigs' in these trials.

During the session, Justices Hrishikesh Roy and S V N Bhatti emphasized the need for trials to be conducted for the benefit of national interests rather than for multinational companies. The Centre's additional solicitor general, Archana Pathak Dave, noted that rules introduced in 2019 and further amended in 2024 aimed to enhance patient safety and ensure adherence to global standards.

The court has given Parikh four weeks to submit his objections while stressing the clinical trials' necessity for aiding India's populace. Dave argued the existing Public Interest Litigations may no longer hold validity given the updated regulations. The rules are under the approval of the Drugs Controller General of India to enhance accountability and protection for participants.

(With inputs from agencies.)