Delhi HC Asks DCGI to Re-examine Approval of Weight Loss Drugs Amid Safety Concerns
The Delhi High Court has directed the Drug Controller General of India (DCGI) to revisit and evaluate regulatory concerns raised in a Public Interest Litigation (PIL) challenging the approval and sale of certain weight loss drug combinations in the country.
A Division Bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Gedela instructed the DCGI to consult medical experts, relevant stakeholders, and drug manufacturers before arriving at any decision. Emphasising the need for preliminary regulatory scrutiny, the Court allowed the petitioner to submit a supplementary representation within two weeks, in addition to an earlier one submitted in April.
The PIL, filed by Jitendra Chouksey and argued by Senior Advocate Diya Kapur along with Advocate Rohit Kumar, seeks a ban on the marketing and distribution of specific GLP-1 receptor agonist (RA) drugs, namely Semaglutide, Tirzepatide, and Liraglutide, for weight loss and cosmetic use.
These drugs, originally developed for managing diabetes, are alleged to have been approved in India without sufficient domestic clinical trials, safety data, or transparent regulatory checks. The petitioner has raised concerns over emerging global reports linking these medications to serious side effects such as cancer risks, organ damage, and neurological complications.
Further, the PIL criticises the unregulated and aggressive promotion of these drugs, particularly targeting younger individuals, and highlights the absence of robust post-marketing surveillance mechanisms. It contends that such regulatory gaps could jeopardise the constitutional right to health and calls for immediate judicial intervention to prevent a potential public health crisis.
The Court directed the DCGI to pass a reasoned order within three months, taking into account expert inputs and industry perspectives before determining the future course of action.