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The Delhi High Court has directed the Drug Controller General of India (DCGI) to examine and address issues raised in a petition challenging the approval and sale of certain weight loss drug combinations in India.
The Court instructed the DCGI to consult medical experts, stakeholders, and drug manufacturers before arriving at any regulatory decision. The bench of Justice Devendra Kumar Upadhyay and Justice Tushar Rao Gedela acknowledged the issues raised and stressed the need for initial regulatory scrutiny. The petitioner has been permitted to submit an additional representation within two weeks, supplementing a previous one submitted in April. The Court further directed the DCGI to provide a well-reasoned decision within three months, considering expert advice and industry input. The proceedings arise from a Public Interest Litigation (PIL) seeking a ban on the sale of weight loss drugs that are still undergoing clinical trials internationally. The PIL specifically raised concern over India's approval of GLP-1 RA drugs--Semaglutide, Tirzepatide, and Liraglutide--for weight loss and cosmetic purposes without adequate India-specific trials, safety data, or regulatory checks. Originally developed for diabetes treatment, these drugs are now under global scrutiny for potentially severe side effects, including cancer risks, organ damage, and neurological complications, the plea stated. The plea also flags the aggressive, unregulated marketing of these drugs--especially to younger demographics--alongside the absence of post-market surveillance and transparency in approval processes. It argues that these regulatory lapses threaten the constitutional right to health and calls for immediate judicial oversight to avert a potential public health crisis. The plea was filed by Jitendra Chouksey, with Senior Advocate Diya Kapur leading the arguments, assisted by Advocate Rohit Kumar. (ANI)
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