Drug Regulator Tightens Watch On GLP-1 Weight-Loss Drugs, Issues Notice

India's drug regulator has intensified surveillance of GLP-1 based weight-loss drugs, targeting their unauthorised sale and promotion across the supply chain amid concerns over rising misuse and easy availability.

The action comes with the entry of multiple generic variants in the market, which officials say has led to on-demand access to these prescription drugs through retail pharmacies, online platforms, wholesalers and wellness clinics.

The Central Drugs Standard Control Organization, along with state regulators, has initiated targeted enforcement measures to curb malpractices and ensure ethical pharmaceutical practices in the supply chain.

As part of the crackdown, inspections and audits were conducted at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers, and slimming clinics, across multiple regions. The checks focused on unauthorised sale, improper prescription practices and misleading or indirect promotion. Notices have been issued to entities found violating norms.

On March 10, the regulator had issued a detailed advisory to manufacturers, reiterating a ban on surrogate advertising and any form of indirect or off-label promotion that could mislead consumers.

Officials said GLP-1 drugs are strictly prescription-only and must be used under medical supervision. In India, they can be prescribed by endocrinologists and internal medicine specialists, and for certain indications, by cardiologists.

Experts have warned that unsupervised use of these drugs can lead to serious adverse effects and health complications.

"Patient safety remains paramount," the regulator stated, adding that the current action is aimed at preventing misuse and ensuring compliance with safety standards.

The regulator has said surveillance will remain heightened in the coming weeks, with violations attracting strict action, including licence cancellation, penalties, and prosecution under applicable laws.

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