'Clinical trials of drugs are often done in poor countries', Supreme Court will hear the petition

On Wednesday, the Supreme Court said that clinical trials of drugs and vaccines are often done in poor countries. On this issue, a petitioner was allowed to file objections and present arguments against the rules made by the Center.

A bench of Justices Rishikesh Rai and SVN Bhatti considered the arguments of Additional Solicitor General Archana Pathak Dave, appearing for the Center, who said that rules for new drugs and clinical trials were made in 2019.

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

Senior advocate Sanjay Parikh, appearing for NGO Swasthya Adhikar Manch, said that poor citizens are still being used as guinea pigs and are not being adequately compensated. Swasthya Adhikar Manch had filed a PIL in 2012 accusing multinational pharmaceutical companies of conducting large-scale clinical trials of drugs across the country.

Parikh told the bench that he wishes to file his objections and arguments in the matter so that proper redressal of grievances is done. However, Dave said the PIL has become infructuous as the rules and amendments were notified in 2019 and 2024 respectively and there is nothing left to consider in this regard. The Supreme Court has granted four weeks to Parikh for filing his objections to the rules.

The rules have been laid down for clinical trials in India, including those about the approval by the Drugs Controller General of India for such trials. The 2024 rules were intended to amend the rules brought in 2019. The apex court had said that clinical trials in India should be for the benefit of the people of this country and not to allow them for the benefit of multinational companies.