Key Points

A bench of Chief Justice Devendra Upadhyaya and Justice Tushar Rao Gedela was hearing a public interest litigation (PIL) against the manner in which Glucagon Like Peptide -1 Receptor Agonist (RA) (GLP-1-RA) drugs, specifically semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for weight loss and aesthetic purposes, despite being originally approved for treatment of Type 2 diabetes.

The PIL, filed through advocate Rohit Kumar, referred to the significant risks posed by these medications, including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy.

In its order, the CJ Upadhyaya-led Bench directed the PIL litigant to submit to CDSCO the scientific studies and data relied upon in the petition.

Asking the CDSCO to decide the representation within 3 months, the Delhi High Court closed the proceedings and disposed of the matter.

As per the petition, GLP-1-RA drugs were originally developed and internationally approved for the treatment of Type 2 Diabetes Mellitus, but over the past few years, have been "repurposed and approved often through accelerated pathways for obesity treatment and chronic weight management, based largely on short-term efficacy trials".

Questioning the CDSCO's grant of marketing approval of these drugs for weight loss purposes in the country, the plea cited limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism.

It said that there is no evidence to suggest that these drugs have undergone rigorous safety evaluation within the Indian population and highlighted the "aggressive" and "unregulated marketing" of these drugs for aesthetic and non-medical purposes.

"Pharmaceutical companies, clinics, and digital wellness platforms are promoting semaglutide and tirzepatide as 'quick-fix' weight loss solutions, especially targeting younger populations, including teenagers. The increasing normalisation of these drugs in aesthetic medicine is alarming," added the PIL.

Further, it said that the lack of transparency surrounding the clinical data submitted for approval of these drugs, the absence of publicly available safety profiles, and the regulatory silence on their off-label use violated the right to health, which encompasses the right to safe medication, informed decision-making, and access to scientific information.

- IANS