Delhi High Court has asked the Drug Controller General of India to consult experts and relevant stakeholders in deciding a plea over drug combinations sold in the market for weight loss treatment.
The Court 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.
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.
In an apparent reference to the recent death of popular TV actor Shefali Jariwala, the court said, “See what happened two-three days back…” News reports suggest Jariwala was taking anti-ageing treatment for the last several years.The petitioner claimed the licenses have been issued without conducting any specific trials and studies and without noting the serious adverse health effects of the drugs.
“These drugs were originally developed and internationally approved for the treatment of Type 2 Diabetes Mellitus, with their primary therapeutic role being the regulation of glycemic levels.
However, over the past few years, they have been repurposed and approved often through accelerated pathways for obesity treatment and chronic weight management, based largely on short-term efficacy trials,” the plea said.
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.
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
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