The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory against pharmaceutical companies engaging in direct or indirect promotional activities relating to anti-obesity drugs under glucagon-like peptide-1 (GLP-1) receptor agonist class and similar prescription drugs indicated for obesity and metabolic disorders.
The advisory has been issued following the Directorate General of Health Services (DGHS), under which the CDSCO operates, noticed that certain pharmaceutical companies may be engaging in direct or indirect (surrogate) promotional activities including disease awareness campaigns, digital medial outreach, and other communications related to GLP-1 receptor agonists and similar prescription drugs.
The CDSCO clarified that the prescription drugs including GLP-1 receptor agonists are required to be prescribed by registered medical practitioners or specialist, as per approved indications and conditions of marketing authorisation.
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 such as diet, exercise, behavioural interventions etc., and which induces demand for pharmacological therapy, may amount to misleading promotion and may attract action under relevant provisions of the Drugs Rules, 1945, including principles under Schedule J of the Rules, it added.
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.
"Any promotional activity, including so-called 'awareness campaigns,' that functions as a surrogate advertisement for prescription-only drugs shall be viewed seriously and may be treated as irrational or misleading marketing practice," said the drug regulator.
It advised the manufacturers, importers and marketing authorisation holders to ensure strict compliance with the Drugs and Cosmetics Act, 1940 and the Rules, and the Prescribing Information/Patient information leaflet/Product Information Sheet (PIS) shall prominently display the details of authorized personnel and the authorized 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.
"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 activities that create brand recall/product visibility of the prescription product, shall also be treated as violations," added the drug regulator.
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 averred.
In order to mitigate any residual risk, the firms need to submit comprehensive Risk Management Plan (RMP) which shall ensure continued safety monitoring and implementation of appropriate risk minimization measures, said the regulator.
Under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 made thereunder, all manufacturers and importers of drugs are required to ensure that manufacture, sale, distribution, and promotion of drug products strictly conform to the approved indications, conditions of permission, labelling requirements, and other statutory provisions. |