CDSCO Approves Wegovy for MASH Treatment

India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), approved Novo Nordisk’s Wegovy (semaglutide injection 2.4 mg) on 17 July 2026 for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults. The approval covers noncirrhotic MASH in adults with moderate to advanced liver fibrosis, along with a reduced-calorie diet and increased physical activity.

Metabolic Dysfunction-Associated Steatohepatitis

MASH is a progressive liver disease linked to metabolic dysfunction and fat accumulation in the liver. It is part of the broader spectrum of metabolic dysfunction-associated steatotic liver disease (MASLD), which includes fatty liver conditions associated with obesity, type 2 diabetes, and dyslipidaemia.

Wegovy and GLP-1 Receptor Agonists

Wegovy contains semaglutide, a GLP-1 receptor agonist used in chronic weight management and metabolic disease care. It became the first and only GLP-1 receptor agonist approved globally and in India for noncirrhotic MASH in adults with moderate to advanced liver fibrosis.

Clinical Trial and Regulatory Process

The approval was based on the ESSENCE clinical trial, which found that 63% of patients treated with Wegovy experienced resolution of steatohepatitis, while 37% showed improvement in liver fibrosis. The CDSCO Subject Expert Committee on Endocrinology and Metabolism had recommended the drug for adults with noncirrhotic MASH with fibrosis stages F2 to F3 at a meeting held on 23 April 2026.

Important Facts for Exams

• Wegovy was first approved in India on 20 April 2022 for chronic weight management.
• Wegovy received MASH approval in the United States in August 2025.
• Wegovy received conditional marketing approval in Canada in December 2025.
• Emcure Pharmaceuticals markets semaglutide in India under the brand name Poviztra.

Pricing and Market Access

Emcure Pharmaceuticals is the exclusive domestic distribution partner for semaglutide under the brand name Poviztra. Effective 3 April 2026, the starting monthly price of Poviztra was reduced to ₹3,999 from ₹8,790, which is a 55% reduction.

Fatty Liver Disease in India

Wegovy’s expanded indication is relevant to India, where Novo Nordisk estimates that about two in three people have fatty liver disease. MASH is associated with obesity and other metabolic disorders, and semaglutide is used in conditions linked to body weight and glucose regulation.