The Central Drugs Standard Control Organisation (CDSCO), India’s National Drug Regulatory authority, has issued an advisory cautioning pharmaceutical companies against the promotion of prescription-only medicines—particularly GLP-1 receptor agonists used for obesity and metabolic disorders—through direct or surrogate advertising.

The advisory, issued under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, reminds drug manufacturers and importers that the manufacture, sale, distribution and promotion of pharmaceutical products must strictly adhere to approved indications, labeling requirements and regulatory conditions.

According to the regulator, certain pharmaceutical companies may be engaging in indirect promotional activities such as disease awareness campaigns, digital outreach and other communications that could effectively function as surrogate advertising for prescription-only medicines, including GLP-1 receptor agonists indicated for obesity management.

CDSCO clarified that prescription medicines must only be prescribed by registered medical practitioners as per approved indications and marketing authorisation conditions. Any promotional communication that promotes prescription drugs to the general public, exaggerates therapeutic benefits, promises guaranteed weight loss outcomes or undermines lifestyle interventions such as diet and physical activity could be considered misleading promotion.

The regulator emphasised that obesity is a chronic metabolic condition that requires comprehensive management involving lifestyle modification, behavioural interventions and preventive healthcare strategies. Pharmaceutical therapy, where appropriate, should not be presented in a manner that diminishes the importance of these public health measures.

As part of the advisory, CDSCO warned that any promotional activity whether through print, digital platforms, social media, influencer engagement or corporate awareness campaigns, that creates brand recall or indirectly promotes prescription-only drugs will be treated as a regulatory violation.

The regulator has directed manufacturers, importers and marketing authorisation holders to ensure strict compliance with applicable legal and ethical standards. Companies have also been asked to prominently display authorised contact details in product information materials and establish complaint mechanisms for consumer queries.

In addition, firms are required to submit comprehensive Risk Management Plans (RMPs) to ensure continued safety monitoring and implementation of risk-minimisation measures for such medicines.

The advisory has also been shared with the Advertising Standards Council of India (ASCI), highlighting the regulator’s intent to curb misleading pharmaceutical marketing practices and protect public health.