Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
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New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three months.The order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three months.However a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same grounds.The court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in question.Notably, Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making Ozempic.Victoza (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and obesity.Legal experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight management.The PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism.Fitness-tech entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it said.The drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
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