Delhi HC Flags Off-Label Use of Diabetes Drugs for Weight Loss, Seeks CDSCO Report

The bench, comprising Chief Justice Manmohan and Justice Tushar Rao Gedela, expressed alarm at the uncontrolled promotion and use of these medications. “Drugs with such serious consequences must be regulated,” the bench remarked. Justice Gedela further commented during the hearing that “such instances should be reported to the police” when informed that in some cases gym trainers were recommending or even administering these medications to individuals seeking weight loss.

The petitioner’s counsel, senior advocate Diya Kapur, submitted that the drugs were originally meant for diabetes but were being sold as a “magic formula for weight loss,” with little awareness among users about possible adverse effects. The court was also informed that these drugs were being obtained and used in gyms and wellness clinics without medical supervision, and that they were “being promoted by influencers and wellness platforms that target younger populations without adequate risk disclosure.”

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Raising further alarm, the PIL contended that these drugs were granted approval “based largely on short-term efficacy trials” and without robust safety evaluations specific to Indian patients. It pointed out that “these drugs were originally developed for the regulation of glycemic levels. However, over time they were repurposed and approved by CDSCO for the treatment of weight loss and obesity in individuals without diabetes, based largely on short-term efficacy trials,” the plea stated as reported by PTI.

The court, noting recent incidents involving unregulated aesthetic or anti-aging treatments, including the death of television actor Shefali Jariwala, remarked, “See what happened two-three days back…it was in the news,” referring to the widespread media coverage of the death. The court said the issue of drug misuse needed to be addressed comprehensively.

Highlighting the potential dangers, the plea cited risks such as pancreatitis, thyroid cancer, pancreatic cancer, cardiovascular and neurological side effects including optic neuropathy. It also referenced a UK report linking 82 deaths to the use of similar GLP-1 receptor agonist drugs. The petition emphasized that despite widespread use, “there is currently no mandatory pharmacovigilance framework to monitor the safety of these drugs in the Indian population.”

The petitioner called for the immediate suspension of approval for non-diabetic use of such drugs and a prohibition on their marketing for weight loss. It also sought that all clinical trial and safety data be made publicly available and that “a public advisory warning should be issued, highlighting the associated risks,” reports LawChakra.

In response, the Delhi High Court disposed of the PIL, but directed the CDSCO to act on the petitioner’s representation. As per the Live Law report, the court said;

“We direct the respondents to take a decision on the petitioner’s representation after consulting experts and stakeholders including manufacturers within three months.” It also permitted the petitioner to “file an additional representation along with all documents relied upon in court within two weeks."

The Economic Times reports that the PIL had further argued that GLP-1 drugs “should not be administered without adequate medical justification, long-term studies, or medical supervision.” It warned that off-label use had turned into a fitness fad and “must be checked before it becomes a public health hazard.”

The court’s order now places responsibility on the CDSCO and DCGI to review the approvals and safety mechanisms associated with these medications. Their decision is expected within three months, by early October 2025, following stakeholder consultation and submission of supporting data by the petitioner.