Indian drug regulator warns of stern action against surrogate advertisements promoting obesity treatment awareness

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This prohibition shall extend to any form of direct or indirect promotional activity in print, electronic, digital, social media, or any other public platform that is intended, directly or indirectly, to promote the product to the general public, the DCGI said.

An advisory issued by DCGI on March 10 said such instances shall be viewed seriously and may be treated as irrational or misleading marketing practice.
An advisory issued by DCGI on March 10 said such instances shall be viewed seriously and may be treated as irrational or misleading marketing practice. | Credits: Fortune India

The Drugs Controller General of India (DCGI) has issued strict warning against promotional activities, including “awareness campaigns," that functions as a surrogate advertisement for prescription-only drugs including the GLP-1 class of obesity and diabetes medications.

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An advisory issued by DCGI on March 10 said such instances shall be viewed seriously and may be treated as irrational or misleading marketing practice. “Advertisement including surrogate advertisement of the said product shall be strictly prohibited. This prohibition shall extend to any form of direct or indirect promotional activity in print, electronic, digital, social media, or any other public platform that is intended, directly or indirectly, to promote the product to the general public. Further, any promotional activity carried out under the pretext of disease awareness, influencer engagement, corporate campaigns or similar actívities that create brand recall/product visibility of the prescription product, shall also be treated as violations”, the advisory issued to all stakeholders states. “All manufacturers and marketing authorization holders shall strictly comply with all applicable ethical and regulatory norms, including ethical marketing practices, to ensure that vulnerable populations are not exploited”, it said.

The drug regulatory agency - Central Drugs Standard Control Organization – has issued the advisory after it took note of the actions of certain pharmaceutical companies that may be seen as direct or indirect (surrogate) promotional activities, including disease awareness campaigns, digital media outreach, and other communications, relating to GLP-1 receptor agonists and similar prescription drugs indicated for obesity and metabolic disorders.

The CDSCO clarified that prescription drugs, including GLP-1 receptor agonists, are required to be prescribed by Registered Medical Practitioners/specialists as per approved indications and conditions of marketing authorization. “Any form of advertisement, whether direct or indirect, which promotes prescription-only medicines to the general public, exaggerates therapeutic efficacу, suggests assured or guaranteed weight loss outcomes, downplays lifestyle modification measures (diet, exercise, behavioural interventions), or induces demand for pharmacological theraру, may amount to misleading promotion and may attract action under relevant provisions of the Drugs Rules, 1945”, it said.

It further clarified that obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions and pharmaceutical therapy, where indicated, must not be projected in a manner that undermines public health initiatives promoting diet control, physical activity, and preventive healthcare measures.

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