The Central Drugs Standard Control Organization (CDSCO) advises all manufacturers, importers, and Marketing Authorization Holders that promotional activities for prescription drugs, including GLP-1 receptor agonists for obesity and metabolic disorders, must comply strictly with the Drugs and Cosmetics Act, 1940 and Rules, 1945. Direct or indirect advertising, including disease awareness campaigns, digital or social media outreach, that misleads or exaggerates therapeutic benefits is prohibited to protect public health and ensure ethical marketing practices.
Under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, all manufacturers and importers must ensure that manufacture, sale, distribution, and promotion of prescription drugs conform to approved indications, labeling, and statutory requirements.
CDSCO has noted potential direct or surrogate promotional activities for GLP-1 receptor agonists and similar drugs.
Key clarifications include:
- Prescription Requirement: Drugs must be prescribed by registered medical practitioners/specialists as per approved indications.
- Prohibited Promotion: Any activity that exaggerates efficacy, guarantees weight loss, downplays lifestyle interventions, or induces demand for pharmacological therapy is misleading.
- Public Health Compliance: Promotion must not undermine diet, exercise, and preventive healthcare initiatives.
- Consumer Safety Measures: Prescribing Information Sheets must include authorized personnel details, contact numbers, and complaint mechanisms.
- Risk Management: Firms should submit a Risk Management Plan (RMP) for ongoing safety monitoring.
All stakeholders must comply to uphold ethical marketing and protect public health.