Supreme Court Raises Concerns Over Clinical Trials in Low-Income Nations

The Supreme Court, on January 8, 2025, expressed concerns over the prevalent practice of conducting clinical trials for medicines and vaccines in economically disadvantaged nations. The court permitted a petitioner to present objections and suggestions regarding the regulations established by the central government.

A bench consisting of Justices Hrishikesh Roy and S.V.N. Bhatti reviewed the submissions made by Additional Solicitor General Archana Pathak Dave. Ms. Dave informed the court that the New Drugs and Clinical Trials Rules were first introduced in 2019. She also highlighted that the New Drugs and Clinical Trials (Amendment) Rules, 2024, were implemented to streamline the approval process, enhance patient safety protocols, and align India’s clinical trial regulations with global standards.

The bench remarked, "We are aware that clinical trials are frequently conducted in poorer countries, reflecting the ethical implications of such practices."

Senior advocate Sanjay Parikh, representing the NGO Swasthya Adhikar Manch, which filed a Public Interest Litigation (PIL) in 2012, alleged that multinational pharmaceutical companies continued to exploit vulnerable populations in India. He argued that impoverished citizens were often used as "guinea pigs" in these trials without adequate compensation. Parikh sought permission to file objections to ensure the grievances of affected individuals were addressed.

In response, Ms. Dave argued that the PIL had become irrelevant since the issues raised were already addressed through the regulations introduced in 2019 and amended in 2024. However, the Supreme Court granted Parikh four weeks to submit his objections for consideration.

In India, clinical trials are regulated by various rules that require approval from the Drugs Controller General of India (DCGI). The 2024 amendments were intended to improve the framework established in 2019, focusing on safeguarding the rights of participants.

The court reiterated that clinical trials conducted within the country should prioritize the welfare of its citizens rather than cater solely to the interests of multinational corporations. In 2013, the court criticized the central government for its inadequate regulations, which failed to sufficiently protect the rights of trial participants. This critique led to the introduction of revised rules.

The PIL alleged that pharmaceutical companies had conducted widespread clinical trials across the country, exploiting Indian citizens without proper oversight or compensation. It called for stricter regulations to ensure that participants' rights and safety were adequately protected.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)