Overview

• The High Court disposed of Jitendra Chouksey’s PIL challenging India’s approval of Semaglutide, Tirzepatide and Liraglutide for weight-loss and cosmetic uses.
• The bench ordered the DCGI to consult medical experts, industry stakeholders and drug manufacturers before reevaluating existing approvals.
• Petitioners have two weeks to submit additional representations to address concerns over the lack of India-specific clinical trials and safety data.
• The DCGI must issue a detailed decision under the Drugs and Cosmetics Act within three months after reviewing the petition.
• The judgment responds to criticism of accelerated approvals based on short-term international trials and reports of aggressive, unregulated marketing