The Drugs Controller General of India (DCGI) has issued a strong advisory cautioning pharmaceutical companies against direct or indirect promotion of prescription medicines used for obesity and metabolic disorders, particularly GLP-1 receptor agonists.
In the advisory issued on March 10 through the Central Drugs Standard Control Organization (CDSCO), the regulator noted that certain companies may be engaging in surrogate promotional practices such as disease awareness campaigns, digital media outreach, and influencer-driven communication that indirectly create brand visibility and demand for prescription-only drugs among the general public.
The regulator stressed that such promotional practices may violate provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, which prohibit advertisement of prescription medicines to the public. According to the advisory, any communication that exaggerates therapeutic benefits, suggests assured or guaranteed weight-loss outcomes, or downplays the importance of lifestyle modifications such as diet control, exercise, and behavioural interventions could be treated as misleading promotion.
The DCGI emphasised that drugs like GLP-1 receptor agonists must only be prescribed by registered medical practitioners and used strictly in line with approved indications and conditions of marketing authorisation.
The advisory further warns that promotional activities carried out under the pretext of disease awareness initiatives, corporate campaigns, or influencer engagement that lead to brand recall or product visibility of prescription medicines will be viewed seriously by regulators. Pharmaceutical manufacturers, importers, and marketing authorization holders have been directed to ensure strict compliance with regulatory norms, refrain from any form of direct or surrogate advertising across print, electronic, digital, or social media platforms, and adopt ethical marketing practices that do not exploit vulnerable populations.
Additionally, companies have been asked to strengthen transparency and patient communication by ensuring that product information sheets and patient information leaflets clearly display details of authorized personnel, office codes, and dedicated contact numbers with complaint or ticket reference mechanisms. The regulator has also advised firms to submit comprehensive risk management plans to support ongoing safety monitoring and risk minimisation measures.
The advisory has been shared with stakeholders and the Advertising Standards Council of India (ASCI) to reinforce compliance and prevent misleading promotion of prescription obesity drugs in the country.
