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India Cautions on GLP-1 Drug Promotions

Summary

  • Regulator warns against promoting GLP-1 drugs to the public.
  • Strict prescription required for semaglutide amid generic launch.
  • Misleading promotion includes disease awareness campaigns.
India Cautions on GLP-1 Drug Promotions

India's Central Drugs Standard Control Organisation (CDSCO) has issued an advisory, mandating that GLP-1 receptor agonists, including semaglutide, must be sold strictly on prescription. This directive comes ahead of the anticipated launch of generic versions of semaglutide, with approximately 50 brands expected in the market soon. The regulator emphasized that any promotion to the general public, exaggerated claims of efficacy, or downplaying lifestyle changes will be considered misleading. Such activities, even under the guise of disease awareness or influencer engagement, will be treated as violations. Semaglutide, initially approved for Type 2 diabetes in 2017, gained significant popularity for weight loss, with higher-dose versions approved for this purpose in 2021. The drug and Eli Lilly's tirzepatide entered the Indian market last year. The CDSCO requires manufacturers to follow ethical marketing, provide consumer contact numbers, and submit comprehensive risk management plans to prevent the exploitation of vulnerable populations.

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