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India Cracks Down on Unauthorised Semaglutide Sales
24 Mar
Summary
- India's drug regulator increased surveillance on semaglutide sales.
- CDSCO inspected 49 entities for unauthorised drug distribution.
- Strict actions will follow for non-compliance with drug regulations.
India's top drug regulator has intensified surveillance following the market entry of generic semaglutide, after Novo Nordisk's patent loss on March 20. The Central Drugs Standard Control Organisation (CDSCO) conducted inspections at 49 diverse entities, including online pharmacies and wellness clinics nationwide.
These inspections aimed to detect violations related to unauthorized sales, improper prescription, and misleading marketing. The CDSCO previously issued an advisory mandating that semaglutide be sold only on prescription from a registered medical practitioner.
Doctors have noted instances of the drug being prescribed by non-medical practitioners, such as dieticians and gym instructors. The health ministry reiterated that semaglutide is approved for prescription by endocrinologists, internal medicine specialists, and for certain indications, cardiologists.
Regulatory surveillance will continue, with strict actions like licence cancellation and prosecution planned for non-compliances. Misleading promotion, including surrogate advertising and exaggerating efficacy while downplaying lifestyle changes, will be viewed seriously.
