Health and Me

Rachel V Thomas

CDSCO threatens action against pharma companies for promoting GLP-1 weight-loss drugs

India's drug regulator, the Central Drugs Standard Control Organization (<span>CDSCO</span>), has threatened pharmaceutical firms with action for promoting GLP-1 weight-loss drugs among the general public.

Glucagon-Like Peptide-1 (GLP-1) receptor agonists are a class of medicines that help lower blood sugar, support weight loss, reduce the risk of heart and kidney complications, and can even lower the risk of early death in people with type 2 diabetes.

In an official circular, the CDSCO warned drug makers from indulging in "direct or indirect advertising" for <span>obesity</span> and metabolic disorders. 

The regulatory body also cautioned pharma companies against campaigns using influencers, noting that any violation "could attract regulatory action". 

Advertisements, which "function as a surrogate advertisement for prescription-only drugs, shall be viewed seriously and may be treated as irrational or misleading marketing practice", read the letter signed by the Drug Controller General of India (DCGI) <span>Rajeev Raghuvanshi</span>. 

The order comes as the CDSCO noted that drugmakers have been engaging in surrogate promotional activities, under the garb of disease awareness campaigns, and digital media outreach.

<ul><li>Weight-loss drugs, specifically GLP-1 medications, must only be sold with a prescription from a registered medical practitioner.</li></ul>

<ul><li>There should be no ads, whether direct or indirect, in print, electronic, digital, social media, or any other public platform intended, directly or indirectly, to promote the product to the general public. </li></ul>

<ul><li>No GLP-1 drugs must exaggerate for therapeutic efficacy; suggest for assured or guaranteed weight loss outcome; and induce demand for pharmacological therapy</li></ul> The CDSCO also called out promotional activity that disguises itself as 

<ul><li>awareness campaigns</li><li>influencer engagement</li><li>corporate campaigns</li></ul>

<h2>Rush For Generic Weight Loss Drugs</h2>

The government's advisory comes patent for semaglutide -- an active ingredient in diabetes and anti-obesity drugs, specifically <span>Wegovy and Ozempic</span> -- expires on March 20. 

This will allow Indian pharma companies to launch cheaper <a href="https://www.healthandme.com/health-news/indian-drugmakers-are-gearing-up-to-launch-generic-semaglutide-injections-as-weight-loss-drugs-patent-expires-in-march-article-153708033" data-type="tilCustomLink">generic versions</a>, significantly increasing affordability and access for millions battling Type 2 diabetes and obesity. 

Major Indian drugmakers gearing up to launch their generic semglutide injection in the country in March include <span>Sun Pharmaceutical Industries</span>, <span>Zydus Lifesciences</span>, <span>Alkem Laboratories</span>, Dr. Reddy’s Laboratories, Torrent Pharmaceuticals, and <span>MSN Laboratories</span>.

<h2>Obesity A Chronic Metabolic Condition</h2>

The CDSCO stressed the importance of "lifestyle modification measures (diet, exercise, behavioural interventions)" in treating obesity. 

"Obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions," the regulator said. 

"Pharmaceutical therapy, where indicated, must not be projected in a manner that undermines public health initiatives promoting diet control, physical activity, and preventive healthcare," it added.

Amid increasing prevalence of GLP-1 drugs, the World Health Organisation (WHO), late last year, acknowledged its role in treating obesity. 

However, it warned that medications like GLP-1 alone will not solve the problem affecting more than one billion people worldwide.

The global health body also issued conditional recommendations for using these therapies as part of a comprehensive approach that includes healthy diets, regular physical activity, and support from health professionals.

Health Conditions A-Z

health

cdsco

GLP 1

reddys laboratories

rajeev raghuvanshi

zydus lifesciences

wegovy and ozempic

sun pharmaceutical industries

msn laboratories

alkem laboratories

obesity

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India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), has threatened pharmaceutical firms with action for promoting GLP-1 weight-loss drugs among the general public.Glucagon-Like Peptide-1 (GLP-1) receptor agonists are a class of medicines that help lower blood sugar, support weight loss, reduce the risk of heart and kidney complications, and can even lower the risk of early death in people with type 2 diabetes.In an official circular, the CDSCO warned drug makers from indulging in "direct or indirect advertising" for obesity and metabolic disorders. The regulatory body also cautioned pharma companies against campaigns using influencers, noting that any violation "could attract regulatory action". Advertisements, which "function as a surrogate advertisement for prescription-only drugs, shall be viewed seriously and may be treated as irrational or misleading marketing practice", read the letter signed by the Drug Controller General of India (DCGI) Rajeev Raghuvanshi. The order comes as the CDSCO noted that drugmakers have been engaging in surrogate promotional activities, under the garb of disease awareness campaigns, and digital media outreach.What The CDSCO Mandated Weight-loss drugs, specifically GLP-1 medications, must only be sold with a prescription from a registered medical practitioner.There should be no ads, whether direct or indirect, in print, electronic, digital, social media, or any other public platform intended, directly or indirectly, to promote the product to the general public. No GLP-1 drugs must exaggerate for therapeutic efficacy; suggest for assured or guaranteed weight loss outcome; and induce demand for pharmacological therapy The CDSCO also called out promotional activity that disguises itself as awareness campaignsinfluencer engagementcorporate campaignsRush For Generic Weight Loss DrugsThe government's advisory comes patent for semaglutide -- an active ingredient in diabetes and anti-obesity drugs, specifically Wegovy and Ozempic -- expires on March 20. This will allow Indian pharma companies to launch cheaper generic versions, significantly increasing affordability and access for millions battling Type 2 diabetes and obesity. Major Indian drugmakers gearing up to launch their generic semglutide injection in the country in March include Sun Pharmaceutical Industries, Zydus Lifesciences, Alkem Laboratories, Dr. Reddy’s Laboratories, Torrent Pharmaceuticals, and MSN Laboratories.Obesity A Chronic Metabolic ConditionThe CDSCO stressed the importance of "lifestyle modification measures (diet, exercise, behavioural interventions)" in treating obesity. "Obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions," the regulator said. "Pharmaceutical therapy, where indicated, must not be projected in a manner that undermines public health initiatives promoting diet control, physical activity, and preventive healthcare," it added.WHO Guidelines On GLP-1 drugsAmid increasing prevalence of GLP-1 drugs, the World Health Organisation (WHO), late last year, acknowledged its role in treating obesity. However, it warned that medications like GLP-1 alone will not solve the problem affecting more than one billion people worldwide.The global health body also issued conditional recommendations for using these therapies as part of a comprehensive approach that includes healthy diets, regular physical activity, and support from health professionals.