No Promotional Campaigns for GLP-1 Obesity Drugs: CDSCO Cautions Pharma Firms
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New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued an advisory cautioning pharmaceutical companies against direct or indirect promotional activities related to GLP-1 receptor agonists and similar prescription medicines used for obesity and metabolic disorders.
The advisory, issued by the Directorate General of Health Services under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, states that manufacturers and importers must ensure that the manufacture, sale, distribution, and promotion of drugs strictly adhere to approved indications, labeling requirements, and conditions of marketing authorization.
It has been brought to the notice of this Directorate that certain pharmaceutical companies may be engaging in direct or indirect (surrogate) promotional activities, including disease awareness campaigns, digital media outreach, and other communications, relating to GLP-1 receptor agonists and similar prescription drugs indicated for obesity and metabolic disorders.
CDSCO clarified that prescription medicines, including GLP-1 receptor agonists, must only be prescribed by registered medical practitioners as per the approved indications. Any form of advertisement or promotional communication directed at the general public for prescription-only medicines is prohibited.
According to the advisory, promotional material that exaggerates therapeutic efficacy, guarantees weight-loss outcomes, downplays lifestyle interventions such as diet and exercise, or induces unnecessary demand for pharmacological therapy may be treated as misleading promotion and may attract regulatory action under the Drugs Rules, including principles outlined in Schedule J.
The regulator also emphasized that obesity is a chronic metabolic condition that requires comprehensive management involving lifestyle modification and preventive healthcare measures. Pharmaceutical therapy, where appropriate, should not be portrayed in a manner that undermines these public health interventions.
Further, CDSCO warned that so-called disease awareness campaigns that indirectly promote prescription products or create brand recall may be treated as surrogate advertisements and considered violations of regulatory norms.
The advisory directs manufacturers, importers, and marketing authorization holders to ensure strict compliance with the Drugs and Cosmetics regulatory framework. Companies have also been asked to ensure that Prescribing Information Sheets and Patient Information Leaflets clearly display details of authorized personnel, office codes, and a dedicated contact number with a complaint or ticket reference mechanism for addressing consumer queries.
In addition, the regulator has mandated that firms submit a comprehensive Risk Management Plan (RMP) to ensure continued safety monitoring and appropriate risk-minimization measures for these medicines.
The CDSCO reiterated that advertisements, including surrogate promotions of such prescription drugs across print, electronic, digital, or social media platforms, are strictly prohibited. Promotional activities conducted under the guise of awareness campaigns, influencer engagement, or corporate branding that enhance product visibility will also be treated as violations.
The advisory concluded by urging all stakeholders to adhere strictly to ethical and regulatory norms to prevent exploitation of vulnerable populations and to safeguard public health.
To view the official notice, click the link below:
