India Steps Up Surveillance on GLP-1 Weight Loss Drug to Curb Misuse

India's Drugs Controller has escalated regulatory action against the unauthorised sale and promotion of GLP-1-based weight loss drugs, as concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics, according to a government release.

The crackdown follows the recent introduction of multiple generic variants of GLP-1-based weight loss drugs in the Indian market. Regulators have flagged that these drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks, the release stated.

In recent weeks, enforcement activities were significantly scaled up, with audits and inspections conducted at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers, and wellness and slimming clinics, spanning multiple regions across the country. The inspections focused on identifying violations related to unauthorized sale, improper prescription practices, and misleading marketing. Notices have also been sent to defaulting entities, according to the release.

The enforcement push was preceded by a formal advisory issued on March 10, to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.

The drug has been approved in India with the condition of prescription by endocrinologists and internal medicine specialists, and for some indications by cardiologists only, the release noted.

Regulatory surveillance will continue to be intensified in the coming weeks, the government said. Non-compliances will be dealt with strictly, with consequences including cancellation of licenses, financial penalties, and prosecution under applicable laws.

Citizens have been advised to use such medications only under the guidance of qualified medical practitioners, the release added.