Central Drugs Standard Control Organisation has initiated a nationwide crackdown to curb potential malpractices in the pharmaceutical supply chain and prevent the unauthorized sale and misuse of GLP-1 receptor agonist-based weight loss drugs, following the rapid entry of multiple generic versions of semaglutide in India.

The move comes amid rising concerns over the increasing availability of these drugs across retail pharmacies, online platforms, wholesalers, and wellness clinics. Authorities have warned that unsupervised use of GLP-1-based therapies can lead to serious adverse health effects, emphasizing the need for strict medical oversight.

Taking cognizance of the situation, India’s drug regulator, in coordination with state authorities, has launched targeted enforcement actions to address irregularities across the supply chain. Regulatory surveillance is being intensified, with strict action planned against non-compliance, including license cancellations, financial penalties, and legal prosecution under applicable laws.

On March 10, 2026, the regulator issued a comprehensive advisory to manufacturers, explicitly prohibiting surrogate advertising and any indirect promotional practices that could mislead consumers or encourage off-label use of these drugs.

Enforcement activities have been significantly scaled up in recent weeks. Inspections and audits were carried out across 49 entities, including online pharmacy warehouses, drug wholesalers, retail outlets, and wellness or slimming clinics. These inspections focused on identifying violations such as unauthorized sales, improper prescription practices, and misleading marketing claims. Notices have been issued to entities found in violation.

The regulator reiterated that patient safety remains the top priority, cautioning that misuse of weight loss drugs without clinical supervision could result in severe health complications. It has advised consumers to use such medications strictly under the guidance of qualified medical practitioners.

Currently, semaglutide-based therapies in India are approved with restrictions, requiring prescriptions from specialists such as endocrinologists and internal medicine practitioners, and for certain indications, cardiologists.

Following patent expiry, several leading pharmaceutical companies—including Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, Zydus Lifesciences, Glenmark Pharmaceuticals, and Alkem Laboratories—have launched generic versions of the drug, significantly improving access while also prompting tighter regulatory oversight.