Clinical trials of medicines, vaccines often carried out in poor countries: SC
Supreme Court of India
New Delhi: Observing that clinical trials of medicines and vaccines are often conducted in poor countries, the Supreme Court has permitted a petitioner to submit objections to the rules established by the Centre on the matter.
A bench comprising Justices Hrishikesh Roy and S. V. N. Bhatti noted, “We know that the clinical trials are conducted in poor countries."
The bench considered submissions made by the Centre's Additional Solicitor General, Archana Pathak Dave, who noted that rules for new drugs and clinical trials had been framed in 2019.
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.
This follows a public interest litigation (PIL) filed by an NGO Swasthya Adhikar Manch in 2012 alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms, PTI reported.
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