Drug regulator issues advisory to pharmaceutical firms against promoting weight loss drugs
Says drug to be prescribed by medical practioners
After the launch of GLP-1 receptor agonists — used to treat obesity and diabetes — the Central Drugs Standard Control Organization (CDSCO) on Wednesday directed the pharmaceutical companies to ensure that manufacture, sale, distribution and promotion of drug products strictly conform to the approved indications, conditions of permission and labelling requirements.
It has also issued a strong advisory, warning pharmaceutical companies against promoting prescription weight-loss drugs to the general public.
“It has been brought to the notice of this Directorate 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,” the advisory said.
The CDSCO clarified that 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.
The CDSCO warned that companies may face action if they in 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,
“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,” the advisory said.
