The Drugs Controller General of India (DCGI) has issued an advisory warning pharmaceutical companies against the direct or indirect promotion of prescription medicines used for obesity and metabolic disorders, particularly GLP-1 receptor agonists.
In a notice dated March 10 and circulated through the Central Drugs Standard Control Organization (CDSCO), the regulator flagged concerns over surrogate promotional tactics such as disease awareness campaigns, digital outreach, and influencer-led content that may indirectly boost brand visibility and demand for prescription-only drugs among the public.
The DCGI underscored that such practices could breach provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, which prohibit advertising of prescription medicines to consumers. It warned that communications exaggerating benefits, promising assured weight loss, or undermining the role of diet, exercise, and behavioural changes may be treated as misleading promotion.
The regulator reiterated that GLP-1-based drugs must be prescribed only by registered medical practitioners and used strictly according to approved indications and marketing authorisation conditions.
It further stated that promotional efforts disguised as awareness drives or corporate campaigns that result in brand recall or product visibility will attract regulatory scrutiny. Companies including manufacturers, importers, and marketing authorisation holders have been directed to comply strictly with norms, avoid any form of direct or indirect advertising across media platforms, and adopt ethical marketing practices that do not target vulnerable groups.
Additionally, firms have been asked to improve transparency by ensuring patient information materials clearly mention authorised contacts, office details, and grievance redressal mechanisms. They have also been advised to submit detailed risk management plans for continuous safety monitoring.
The advisory has been shared with stakeholders and the Advertising Standards Council of India to strengthen oversight and curb misleading promotion of prescription obesity drugs in India.
