Regulator warns pharma firms over promotion of obesity drugs

India’s drug regulator has cautioned pharmaceutical companies against promoting prescription medicines used for obesity and metabolic disorders, including GLP-1 receptor agonists, through surrogate advertising or disease-awareness campaigns aimed at the public.

In an advisory issued on Tuesday, the Central Drugs Standard Control Organisation (CDSCO) said promotional activities relating to prescription medicines must strictly adhere to the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

The advisory, issued by Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), said the regulator had received information suggesting that some pharmaceutical companies may be engaging in direct or indirect promotional campaigns, including digital outreach, disease-awareness drives, and other communications related to GLP-1 receptor agonists and similar drugs indicated for obesity and metabolic disorders.

Industry executives said such promotional activity may include indirect brand-visibility campaigns, influencer-led discussions on weight-loss medicines, sponsored disease-awareness programmes on obesity and metabolic disorders, and digital marketing content highlighting treatment outcomes without naming specific prescription brands.

“Prescription drugs, including GLP-1 receptor agonists, are required to be prescribed by registered medical practitioners as per approved indications and conditions of marketing authorisation,” Raghuvanshi said.

The regulator said such medicines are prescription-only and must be used strictly in accordance with approved indications and prescribing guidance.

The CDSCO warned that promotional activities that exaggerate therapeutic efficacy, suggest guaranteed weight-loss outcomes, or induce demand for pharmacological therapy may be treated as misleading marketing practices and could attract action under the relevant provisions of the Drugs Rules.

“Any promotional activity, including so-called disease-awareness campaigns that function as surrogate advertisements for prescription medicines, will be viewed seriously under the provisions of the Drugs Rules,” Raghuvanshi said.

Pharma analyst Salil Kallianpur said regulators globally have historically remained cautious about obesity medicines because safety monitoring tends to intensify as the number of patients increases. “The larger the patient population becomes, the more closely regulators tend to scrutinise safety, prescribing behaviour, and industry practices,” he said.

The advisory also emphasised that obesity is a chronic metabolic condition requiring comprehensive management, and said pharmacological therapies should not be projected in a manner that undermines the importance of lifestyle interventions such as a balanced diet, physical activity, and behavioural changes.

The regulator further stated that any form of advertisement, direct or indirect, promoting prescription medicines to the general public would be treated as a violation. This includes promotional activity in print, electronic, and digital media, social media campaigns, influencer marketing, corporate campaigns, and other public platforms that increase brand visibility for prescription medicines.

Companies have also been directed to ensure that prescribing information and patient-information leaflets clearly display authorised personnel details, office codes, and contact numbers for addressing consumer queries and complaints.

The advisory further asked pharmaceutical companies to submit appropriate risk-management plans to ensure continued safety monitoring and implementation of risk-minimisation measures associated with these medicines.

The CDSCO said the communication has been circulated to pharmaceutical companies and industry stakeholders, including the Advertising Standards Council of India (ASCI), as part of efforts to ensure responsible communication and compliance with regulatory requirements in the marketing of prescription medicines.

The warning comes at a time when pharmaceutical companies are preparing multiple launches of GLP-1 therapies in India as patent barriers ease and competition in the obesity-treatment segment intensifies. Industry estimates suggest India’s anti-obesity drug market is currently valued at around ₹3,000–₹3,500 crore and could expand rapidly over the coming years as newer metabolic therapies become more widely available.

The regulator said the move is intended to reinforce safeguards around the promotion of prescription drugs as global interest grows in newer therapies used for obesity and metabolic disorders.