3 Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs 2026-May-18 75 KB

Directorate General of Health Services Central Drugs Standard Control Organization (Enforcement & Intelligence Cell)

F. No. Enforc-11021(11)/34/2026-eoffice-Part(1) Government of India

FDA Bhawan, Kotla Road New Delhi-110002 a Dated:

All State/UT Drug controllers

Subject: Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs — Reg

Sir/Madam,

Over the past several weeks, CDSCO, in coordination with State Licensing Authorities (SLAs), has undertaken a nationwide enforcement drive to curb illegal distribution channels, noncompliant dispensing practices, and misuse of GLP-1-based weight loss drugs. As part of this initiative, audits and inspections were carried out across multiple regions at various entities, including online pharmacy warehouses, drug wholesalers, retail outlets, and wellness and slimming clinics. Additionally, notices have been issued to entities found to be in violation of the conditions of the permission and warning on label. Press release in this regard has been issued on 24.03.2026. State and Union Territory Drug Controllers are requested to strengthen monitoring of the endto-end supply chain of the GLP-1-based weight loss drugs to ensure strict adherence to the conditions of approval and the warnings on the labei. This includes ensuring that manufacture/import, distribution, retailAwholesale sales, and dispensing occur only through authorized channels and strictly in line with approved indications and labelling. Any diversion, leakage into unauthorized channels, promotions influencing supply practices, or non-adherence to approval conditions should be viewed seriously with appropriate regulatory action.

Further, all State and Union Territory Drug Controllers are also requested to actively monitor print, electronic, digital, social-media, and outdoor platforms for non-compliant advertisements or surrogate promotional activities relating to these drugs. Appropriate action should be initiated under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, Drugs and Cosmetics Act, 1940 and Rules made thereunder against manufacturers, importers, marketers, or any other entities found in violation. Where required, coordination with the Advertising Standards Council of India (ASCI) and other relevant agencies may be undertaken for effective enforcement.

You are also requested to issue advisory to stakeholders in your states for necessary compliance of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, Drugs and Cosmetics Act, 1940 and Rules made thereunder and advisory issued by this office.

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----- Start of picture text -----<br> (Dr. Rajeev $i ghuvanshi)<br>Drugs Controlle General (I)<br>----- End of picture text -----<br>

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e All CDSCO Zonal/Sub-zonal offices e Guard file F. No. Enforc-11021(11)/34/2026-eoffice-Part(1)