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.

NEW DELHI:

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.