NEW DELHI: The Drugs Controller General of India (DCGI) has issued strict warning against any surrogate advertisements, including awareness campaigns, for prescription-only drugs.
The regulator in an advisory said, “Any promotional activity, including so-called 'awareness campaigns' that function as a surrogate advertisement for prescription-only drugs shall be viewed seriously and may be treated as irrational or misleading marketing practice.”
The advisory issued by DCGI Dr Rajeev Singh Raghuvanshi said all manufacturers, importers, and marketing authorisation holders should ensure strict compliance with the Drugs and Cosmetics Act, 1940 and Rules.
“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 activities that create brand recall/product visibility of the prescription product, shall also be treated as violations,” the March 10 advisory said.
The DCGI also advised all manufacturers and marketing authorisation holders to “strictly comply with all applicable ethical and regulatory norms, including ethical marketing practices, to ensure that vulnerable populations are not exploited.”
To mitigate any residual risk, the firms were asked to submit a comprehensive Risk Management Plan (RMP), "which shall ensure continued safety monitoring and implementation of appropriate risk minimisation measures."
It added 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 authorisation.
"In view of the above all stakeholders are advised to adhere to this advisory in public interest,” the advisory added.
The advisory also said that the Prescribing Information/ Patient information leaflet/ Product Information Sheet (PIS) shall prominently display the details of authorised personnel and the authorised office code. The PIS shall also provide a dedicated contact number along with a complaint/ticket reference mechanism for addressing consumer queries and facilitating reporting, said the advisory, which was also marked to the Advertising Standards Council of India (ASCI).
“Obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions. 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,” the advisory added.
The advisory was issued after the issue was flagged to the DCGI that “certain pharmaceutical companies may be engaging in 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.”
Under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, all manufacturers and importers of drugs are required to ensure that the manufacture, sale, distribution, and promotion of drug products strictly conform to the approved indications, conditions of permission, labelling requirements, and other statutory provisions.
Any form of advertisement, whether direct or indirect, which promotes prescription-only medicines to the general public; exaggerates therapeutic efficacy; suggests assured or guaranteed weight loss outcomes; downplays lifestyle modification measures (diet, exercise, behavioural interventions); or induces demand for pharmacological therapy may amount to misleading promotion and may attract action under relevant provisions of the Drugs Rules, 1945, including principles underlying Schedule J of the said rules.