CDSCO Cautions Pharma Companies Against Promotion of GLP-1 Obesity Drugs 

Key Highlights: 

• Central Drugs Standard Control Organisation has issued an advisory warning pharmaceutical manufacturers, importers, and marketing authorisation holders against direct or indirect promotional activities for prescription drugs used in obesity and metabolic disorders, including GLP-1 receptor agonists. 

• The regulator said prescription-only medicines must only be promoted in line with approved indications under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. Any public-facing advertisements, influencer campaigns, or awareness initiatives that create brand recall for such drugs could be considered misleading or surrogate advertising. 

• CDSCO also directed companies to ensure ethical marketing practices, clear prescribing information, and submission of Risk Management Plans (RMPs) to strengthen post-marketing safety monitoring, emphasizing that obesity management should prioritize lifestyle interventions alongside responsible pharmaceutical use.  

Implications: 

This curbs aggressive GLP-1 marketing (e.g., Ozempic/Wegovy), protecting India’s $115M diabetes/obesity segment from off-label hype amid 101M diabetics. 
Ahead of semaglutide patent expiry/generic launches (40-50% price drop FY27), it favors ethical B2B strategies 

Source: Expresspharma | Image: CDSCO