Misuse of Ozempic and other diabetes drugs for weight loss: Delhi High Court directs CDSCO to respond

The Delhi High Court on Tuesday disposed of a public interest litigation (PIL) raising alarm over the off-label and unregulated use of powerful anti-diabetic drugs like Ozempic for weight loss, while directing the Central Drugs Standard Control Organisation (CDSCO) to respond to the petitioner’s representation within three months. [Jitendra Chouksey v. Union of India].The drugs in question include widely known anti-diabetic medications such as Ozempic (Semaglutide), Mounjaro (Tirzepatide) and Victoza (Liraglutide). Originally developed to manage Type 2 Diabetes by regulating blood sugar levels, these GLP-1 receptor agonists have gained global popularity for their secondary effect of promoting weight loss..A Bench of Chief Justice Devendra Kumar Upadhyay and Justice Tushar Rao Gedela expressed serious concern over the misuse of these drugs, particularly when they are procured over the counter without prescriptions. The Court orally observed that drugs with such serious consequences must be regulated. .Senior Advocate Diya Kapur, appearing for the petitioner, highlighted that some gyms were prescribing these drugs as a “magic formula” for weight loss. Justice Gadela remarked that such instances should be reported to the police..The PIL, filed by Jitendra Chouksey, flagged that these drugs have increasingly been repurposed for aesthetic weight loss without adequate India-specific clinical trials, safety evaluations or regulatory safeguards. The petition cited 82 deaths reported in the UK and pending lawsuits in the United States, warning of serious health risks including pancreatitis, thyroid cancer, cardiovascular complications and potential neurological damage..It further raised concerns about the unregulated promotion of these medications via influencers, clinics and digital wellness platforms, particularly targeting youngsters.Arguing that this constituted a violation of the right to health under Article 21 of the Constitution and the precautionary principle, the petitioner sought urgent regulatory interventions, including suspension of approvals for non-diabetic use, a ban on off-label promotion and institution of a pharmacovigilance mechanism..While the Court did not issue directions on those substantive prayers, it directed CDSCO to consider the petitioner’s representation and file a reasoned reply within three months, and asked the petitioner to place on record copies of the studies and data relied upon..Parallelly, the Delhi High Court is also hearing the dispute between Dr. Reddy's and Novo Nordisk (the manufacturer of Ozempic) over the patent of Ozempic. Ozempic, launched in 2017, is a once-weekly injectable GLP-1 receptor agonist widely prescribed for the treatment of Type 2 Diabetes. In recent years, it has also seen rising global demand for off-label use as a weight-loss drug. Its active compound, Semaglutide, is considered one of the most commercially successful molecules in the pharmaceutical market today, making the underlying patent a critical commercial asset for Novo Nordisk..For the petitioners, Kapur was briefed by Advocates Rohit Kumar, Aditya Ladha, Raghav Kumar, Ujjawal Gaur and Aakansha Chauhan.