DCGI intensifies crackdown on GLP-1 drug misuse, sales and misleading ads

The Drugs Controller of India has intensified its regulatory surveillance to uphold ethical pharmaceutical practices across the GLP-1 weight loss drugs supply chain, with a focus on curbing unauthorised sale and promotion.

Over the past several weeks, audits and inspections were carried out across 49 entities spanning online pharmacy warehouses, drug wholesalers, retailers, and wellness and slimming clinics across multiple regions of the country.

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The inspections focused on critical violations, including unauthorised sale, improper prescription practices, and misleading promotional activities, with notices subsequently issued to all defaulting entities, the drug regulator said in a statement.

The regulator has said that the surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws.

The recent introduction of multiple generic variants of GLP-1weight loss drugs in the Indian market has raised significant concerns over their on-demand availability across retail pharmacies, online platforms, wholesalers, and wellness clinics, given the serious adverse effects and health risks associated with their use without proper medical supervision.

Taking cognizance of the situation, India’s Drugs Controller, in collaboration with State Regulators, initiated a series of targeted actions to curb malpractices across the pharmaceutical supply chain and prevent unauthorized sale and use.

As part of these measures, an advisory was earlier prohibiting manufacturers from engaging in surrogate advertisements or any form of indirect promotion that could mislead consumers or encourage off-label usage.

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“In the recent weeks, enforcement activities were significantly scaled up,” it further said.

The drug regulator has advised people to take these medications “only under the guidance of qualified medical practitioners”.

“It is important to reiterate here that the drug has been approved in India with condition of prescription by Endocrinologists and Internal Medicine Specialist and for some indications by Cardiologists only”.