New Delhi [India], March 12 (HBTV): The Central Drugs Standard Control Organization (CDSCO) has issued an advisory to pharmaceutical manufacturers, importers, and marketing authorisation 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 advisory highlighted concerns regarding certain promotional activities, including disease awareness campaigns and digital outreach, that may indirectly promote prescription-only medicines to the general public.
The CDSCO clarified that such drugs must be prescribed only by registered medical practitioners in accordance with approved indications and conditions of marketing authorisation.
The regulator 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.
It also warned that activities exaggerating therapeutic claims, guaranteeing weight-loss outcomes, or undermining the importance of lifestyle modifications such as diet and physical activity would be treated as misleading promotion.
The CDSCO advised all stakeholders to strictly adhere to regulatory and ethical marketing standards. Firms were also directed to ensure proper prescribing information, maintain consumer grievance mechanisms, and submit comprehensive Risk Management Plans (RMPs) to ensure continued safety monitoring.
The advisory emphasised that obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions, and stated that pharmaceutical therapy should not be projected in a manner that undermines broader public health initiatives.
(ANI)