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The Central Drugs Standard Control Organization (CDSCO) has issued an advisory to pharmaceutical manufacturers, importers, and marketing authorization holders to ensure strict compliance with the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945 in the promotion and marketing of prescription medicines, particularly GLP-1 receptor agonists and similar drugs indicated for obesity and metabolic disorders, the release said.
The advisory highlights concerns regarding certain promotional activities, including disease awareness campaigns and digital outreach, that may indirectly promote prescription-only medicines to the general public. CDSCO has clarified that such drugs must be prescribed only by Registered Medical Practitioners in accordance with approved indications and conditions of marketing authorisation.The regulator has reiterated that any direct or indirect advertisement of prescription medicines to the public is strictly prohibited, including promotional activities on print, electronic, digital, or social media platforms. Activities that exaggerate therapeutic claims, guarantee weight-loss outcomes, or undermine the importance of lifestyle modifications such as diet and physical activity will be treated as misleading promotion. CDSCO has advised all concerned stakeholders to strictly adhere to regulatory and ethical marketing standards. Firms have also been directed to ensure proper prescribing information, maintain consumer grievance mechanisms, and submit comprehensive Risk Management Plans (RMPs) to ensure continued safety monitoring. The advisory emphasises that obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions, and pharmaceutical therapy should not be projected in a manner that undermines broader public health initiatives. (ANI)
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