The Delhi High Court has ordered India's drug regulatory authority to review the safety and licensing of popular diabetes medications being used for weight loss, following concerns about inadequate clinical trial data and potential health risks.
A bench comprising Chief Justice D.K. Upadhyaya and Justice Tushar Rao Gedela directed the Central Drugs Standard Control Organisation (CDSCO) on July 2, 2025, to decide within three months on a petition filed by Jitendra Chouksey challenging the marketing approval of GLP-1 receptor agonist drugs for weight management purposes.
Regulatory Concerns Over Drug Repurposing
The petition specifically targets three medications: semaglutide, tirzepatide, and liraglutide, which were originally developed and internationally approved for treating Type 2 diabetes mellitus. According to the plea, these drugs have been "repurposed and approved often through accelerated pathways for obesity treatment and chronic weight management, based largely on short-term efficacy trials."
Chouksey's petition alleges that the CDSCO "has recently approved these drugs for weight-loss purposes without requiring large-scale clinical trials specific to Indian demographics or mandating post-marketing surveillance." The petitioner emphasized that there is no evidence suggesting these drugs have undergone rigorous safety evaluation within the Indian population.
Safety Profile Under Scrutiny
The petition highlights significant safety concerns associated with GLP-1 receptor agonist drugs, citing "numerous studies" that have identified risks including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy.
The court filing describes how these medications have been granted marketing approval "despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism."
Commercial Promotion Concerns
Beyond regulatory approval issues, the petition raises concerns about how these drugs are being marketed to consumers. Chouksey cautioned that "pharmaceutical companies, clinics, and digital wellness platforms are promoting the drug combinations as 'quick-fix' weight-loss solutions."
This commercial approach has raised questions about whether patients are being adequately informed about the potential risks associated with using diabetes medications for weight management purposes.
Court's Directive for Expert Consultation
The Delhi High Court emphasized that the CDSCO must "consult experts and relevant stakeholders" before making its decision on the petition. Chief Justice Upadhyaya's bench directed the petitioner to submit scientific studies and data relied upon in the petition to the regulatory authority.
The court allowed Chouksey to "move the authority and bring relevant material and documents to its notice," ensuring that the CDSCO has access to all relevant information when making its determination.
Regulatory Timeline and Next Steps
With the three-month deadline established by the court, the CDSCO now faces pressure to conduct a comprehensive review of the safety and efficacy data for these repurposed diabetes medications. The regulatory authority will need to evaluate whether current approval processes adequately protect Indian patients using these drugs for weight management.
The case represents a significant challenge to India's drug approval processes, particularly regarding the repurposing of existing medications for new therapeutic indications without population-specific clinical trial data.
