Clinical trials of medicines often done in poor countries, says SC

Observing clinical trials of medicines and vaccines were often carried out in poor countries, the Supreme Court on Wednesday allowed a petitioner to file submissions and objections to the rules framed by the Centre on the issue.

A bench comprising Justices Hrishikesh Roy and S V N Bhatti considered the submissions of Centre's additional solicitor general Archana Pathak Dave who said rules for new drugs and clinical trials were framed in 2019.

"We know that the clinical trials are conducted in poor countries," the bench said.

Following the rules, Dave said New Drugs and Clinical Trials (Amendment) Rules were notified in 2024 to streamline the approval process for clinical trials and new drugs in India which aimed to improve patient safety protocols and ensure compliance with global standards.

Senior advocate Sanjay Parikh, appearing for NGO Swasthya Adhikar Manch, which filed a PIL in 2012 alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms, said poor citizens were still being used as "guinea pigs" and not paid adequate compensation.

The senior lawyer said he wanted to file his objections and submissions in the case to ensure a proper redressal of the grievances.

Dave, however, said the PILs had become infructuous as the rules and the amendments were notified in 2019 and 2024, respectively, and nothing remained to be dealt with.

The top court granted four weeks to Parikh to file his objections to the rules and otherwise.

Clinical trials in India are governed by several rules, including the approval of the Drugs Controller General of India for such trials.

The 2024 rules were intended to make changes to the existing ones introduced in 2019.

The top court had said clinical trials in the country must be for the help of people in the country and not be allowed for the benefits of multinational companies.

In 2013, it said norms formulated by the Centre were "deficient" to protect the rights of the subjects following which new rules were introduced.

The PIL alleged clinical drug trials by various pharmaceutical firms took place indiscriminately across states in the country and used Indian citizens as guinea pigs.