CDSCO issues advisory against promotion of prescription obesity drugs 

The Central Drugs Standard Control Organization (CDSCO) has issued an advisory cautioning pharmaceutical manufacturers, importers, and marketing authorisation holders against direct or indirect promotional activities related to prescription drugs indicated for obesity and metabolic disorders, including GLP-1 receptor agonists.

The advisory, issued under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, reiterates that the manufacture, sale, distribution, and promotion of drug products must strictly comply with approved indications, labeling requirements, and other regulatory provisions.

According to CDSCO, it has come to the regulator’s notice that some pharmaceutical companies may be engaging in direct or indirect promotional activities—such as disease awareness campaigns, digital media outreach, and other communications—related to GLP-1 receptor agonists and similar prescription medicines used in the management of obesity and metabolic disorders.

The regulator clarified that prescription-only medicines must be prescribed by registered medical practitioners or specialists in accordance with approved indications and marketing authorization conditions. Any advertisement—direct or surrogate—that promotes prescription medicines to the general public, exaggerates therapeutic benefits, promises guaranteed outcomes such as assured weight loss, or downplays essential lifestyle interventions may be considered misleading and could invite regulatory action.

CDSCO emphasised that obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle measures such as diet control, physical activity, and behavioural interventions. Pharmaceutical therapy, where indicated, must not be promoted in a manner that undermines public health initiatives promoting preventive healthcare.

The advisory also cautions that promotional activities conducted under the guise of “awareness campaigns,” influencer engagement, or corporate communications that create brand recall or visibility for prescription medicines will be treated as surrogate advertising and may be considered a violation of regulatory norms.

Further, pharmaceutical companies have been directed to ensure strict adherence to ethical marketing practices. The regulator has also instructed that prescribing information, patient information leaflets, and product information sheets should clearly display details of authorised personnel, office codes, and dedicated contact mechanisms for addressing consumer queries and complaints.

To strengthen post-marketing safety monitoring, CDSCO has advised companies to submit comprehensive Risk Management Plans (RMPs) to ensure continued safety evaluation and implementation of appropriate risk minimisation measures.

The regulator has urged all stakeholders in the pharmaceutical sector to strictly adhere to the advisory in the interest of public health.