Delhi High Court asks DGCI to decide on plea against licensing of weight-loss drugs
A bench of Chief Justice D. K. Upadhyaya and Justice Tushar Rao Gedela asked the petitioner, Jitendra Chouksey, to give a representation to the DGCI, which was asked to decide the matter within three months.
Mr. Chouksey, in his plea, alleged licenses issued for the use and sale of such drugs were not based on adequate data.
The court, however, said the plea's concerns have to be first looked into and addressed by the DCGI. It allowed Mr. Chouksey to move the authority and bring relevant material and documents to its notice.
Lack of clinical trials
The plea raised concerns regarding the manner in which 'Glucagon-like peptide-1 receptor agonist (RA) drugs, specifically semaglutide, tirzepatide, and liraglutide, have been granted marketing approval in India for use in weight management and aesthetic treatments, despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism.'
It claimed that 'numerous studies have further highlighted the significant risks posed by these medications, including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy.'
The plea said 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,' it added.
The plea said, 'In India, the CDSCO (Central Drugs Standard Control Organisation) has recently approved these drugs for weight- loss purposes without requiring large-scale clinical trials specific to Indian demographics or mandating post-marketing surveillance.'
Mr. Chouksey said there is no evidence to suggest that these drugs have undergone rigorous safety evaluation within the Indian population. He cautioned that pharmaceutical companies, clinics, and digital wellness platforms are promoting the drug combinations as 'quick-fix' weight-loss solutions.
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