New Delhi, March 11 The apex drug regulator, CDSCO, has issued an advisory, directing that weight-loss drugs, specifically GLP-1 medications, must only be sold with a prescription from a registered medical practitioner.
It cautioned pharmaceutical companies against "directly or indirectly" promoting prescription medicines such as GLP-1 receptor agonists for obesity and metabolic disorders to the general public.
The Drugs Controller General of India issued the advisory on Tuesday.
The Central Drugs Standard Control Organisation (CDSCO) in the advisory, said that all stakeholders, including manufacturers, importers, must ensure that their manufacturing, sale, distribution and promotion strictly conform to the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
The regulator highlighted that certain pharmaceutical companies may be engaging in direct or indirect promotional activities, including disease awareness campaigns, digital media outreach related to GLP-1 and similar prescription drugs.
"Prescription drugs, including GLP-1 receptor agonists, are required to be prescribed by registered medical practitioners or specialists according to the approved indications and conditions of marketing authorisation," the advisory said.
It warned that any form of advertisement -- direct or indirect -- promoting such medicines to the general public could attract regulatory action under relevant provisions of the Drugs Rules, including principles underlying Schedule J, the advisory said.
The regulator emphasised that obesity is a chronic metabolic condition, requiring comprehensive management, including lifestyle interventions, it said.
Any pharmaceutical therapy should not undermine public health initiatives promoting diet control and physical activity, it added.
The advisory, which was also shared with the Advertising Standards Council of India (ASCI), said, "awareness campaigns" that function as a surrogate advertisement may also be treated as an irrational or misleading marketing practice.
The advisory also directed manufacturers and marketing authorisation holders to ensure that prescribing information and patient information leaflets prominently display details of authorised personnel and office codes, along with a dedicated contact number and complaint or ticket mechanism for consumer queries.
The advisory strictly prohibited the advertisement or surrogate promotion of such products across print, electronic, digital or social media platforms.
Companies have also been asked to submit a comprehensive Risk Management Plan (RMP) to ensure continued safety monitoring and implementation of appropriate risk-minimisation measures.