Regulator steps up oversight of GLP-1 drug distribution chain

New Delhi: India's drug regulator has asked the state drug controllers to strengthen monitoring of the end-to-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 label.

The drug regulator has asked the state authorities to ensure that manufacture/import, distribution, retail/wholesale sales, and dispensing occur only through authorised channels and strictly in line with approved indications and labelling, in an advisory dated March 27. "Any diversion, leakage into unauthorised channels, promotions influencing supply practices, or non-adherence to approval conditions should be viewed seriously with appropriate regulatory action," the letter said. All State and Union Territory drug controllers have also been asked 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," the letter said.


Where necessary, the state drug controllers are asked to coordinate with the Advertising Standards Council of India (ASCI) and other relevant authorities to ensure effective enforcement.

Over the past several weeks, the Central Drugs Standard Control Organisation (CDSCO), in coordination with state Licensing Authorities (SLAs), has conducted a comprehensive nationwide enforcement campaign targeting the illegal distribution, non-compliant dispensing, and misuse of GLP-1-based weight loss medications.

As part of an initiative, coordinated audits and inspections were carried out across multiple regions, covering a wide range of entities.