Drugs controller cracks down: Strict action against unapproved weight loss meds

Regulatory actions include audits, inspections, and notices to violators, emphasizing patient safety and prescription-only use

Published On 2026-03-24 09:14 GMT   |   Update On 2026-03-24 09:14 GMT

New Delhi (The Uttam Hindu) : To ensure ethical pharmaceutical practices in the supply chain of weight loss drug (GLP-1), the Drugs Controller of India has intensified its regulatory monitoring against unauthorized sale and promotion of the drug.

The recent introduction of several generic variants of GLP-1-based weight loss drugs into the Indian market has raised concerns about their "on-demand availability" through retail pharmacies, online platforms, wholesalers, and wellness clinics. When these drugs are used without proper medical supervision, they can cause serious side effects and associated health risks.

Taking cognizance of the situation, the Drugs Controller of India, in collaboration with state regulators, has initiated several targeted actions to prevent potential malpractices in the pharmaceutical supply chain and to prevent unauthorized sale and use.

A detailed advisory was issued to all manufacturers on 10 March 2026, explicitly prohibiting 'surrogate advertisements' (indirect advertisements) and any form of indirect promotion that may mislead consumers or promote 'off-label use' (use of a drug for which it is not approved).

Enforcement activities have been significantly increased in recent weeks. Audits and inspections were conducted at 49 entities, including online pharmacy warehouses, pharmaceutical wholesalers, retailers, and wellness and slimming clinics. These inspections were conducted in various regions across the country and were primarily aimed at identifying violations related to unauthorized sales, improper prescribing practices, and misleading marketing. Notices were also issued to entities found to be in violation.

The regulator emphasizes that patient safety is paramount. Incorrect use of weight loss medications without medical supervision can lead to serious health complications. Citizens are advised to use such medications only under the guidance of a qualified physician.

The drug has been approved in India with the condition that it be prescribed only by endocrinologists (hormone specialists) and internal medicine specialists, and in certain conditions only by cardiologists (cardiologists). Regulatory oversight will be intensified in the coming weeks, and strict action will be taken against non-compliance, including license cancellation, fines, and prosecution under applicable laws.

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