CDSCO Approves Wegovy (Semaglutide) for Treating Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Key Facts

• On 17 July 2026, the Central Drugs Standard Control Organization (CDSCO), India's drug regulator, approved Novo Nordisk's Wegovy (semaglutide injection 2.4 mg) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults.
• The approval specifically covers noncirrhotic MASH in adults with moderate to advanced liver fibrosis (stages F2 to F3), to be used alongside a reduced-calorie diet and increased physical activity.
• MASH is a progressive liver disease characterized by fat accumulation and inflammation, associated with metabolic dysfunction. It is a subset of metabolic dysfunction-associated steatotic liver disease (MASLD), which includes conditions linked to obesity, type 2 diabetes, and dyslipidaemia.
• Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, which is used in chronic weight management and the treatment of metabolic diseases.
• This approval makes Wegovy the first and only GLP-1 receptor agonist approved globally and in India for noncirrhotic MASH with moderate to advanced liver fibrosis.
• The approval followed evidence from the ESSENCE clinical trial in which 63% of patients treated with Wegovy experienced resolution of steatohepatitis, and 37% showed improvement in liver fibrosis.
• The CDSCO Subject Expert Committee on Endocrinology and Metabolism recommended the drug for this use on 23 April 2026.
• Wegovy was first approved in India on 20 April 2022 for chronic weight management.
• Wegovy received approval for MASH treatment in the United States in August 2025 and conditional marketing approval in Canada in December 2025.
• In India, Emcure Pharmaceuticals is the exclusive domestic distributor marketing semaglutide under the brand name Poviztra. The monthly price of Poviztra was reduced by 55% from ₹8,790 to ₹3,999 effective 3 April 2026.
• According to Novo Nordisk estimates, about two in every three people in India suffer from fatty liver disease.

Background & Context

Metabolic dysfunction-associated steatohepatitis (MASH) is a severe and progressive liver disease caused by excess fat accumulation and inflammation in the liver due to underlying metabolic dysfunction. It is part of a broader spectrum called metabolic dysfunction-associated steatotic liver disease (MASLD), encompassing a range of fatty liver diseases related to obesity, type 2 diabetes, and abnormal lipid metabolism. If untreated, MASH may progress to cirrhosis and liver failure.

Semaglutide is a GLP-1 receptor agonist that modulates glucose metabolism and supports weight reduction, addressing key metabolic risk factors associated with MASH. Its approval offers a pharmacological intervention complementing lifestyle measures such as dietary changes and physical activity, potentially improving liver health and disease outcomes.

Why This Matters for Exams / Exam Relevance

This drug approval is significant for understanding recent advancements in the treatment of metabolic and liver diseases within the Indian healthcare regulatory framework. Knowledge of regulatory bodies like CDSCO and their approval processes is often tested in exams. Details such as drug names, indications, clinical trial data (ESSENCE trial outcomes), fibrosis staging (F2–F3), distributor roles, and pricing strategies are relevant for students of medical, pharmaceutical, and health science courses. Additionally, understanding metabolic conditions linked to liver diseases aligns with syllabus topics in biochemistry, pathology, and clinical therapeutics.

Points to Remember

• CDSCO approved Wegovy (semaglutide 2.4 mg injection) for noncirrhotic MASH with moderate to advanced liver fibrosis on 17 July 2026.
• ESSENCE clinical trial showed 63% resolution of steatohepatitis and 37% improvement in fibrosis among treated patients.
• Wegovy was previously approved in India for chronic weight management in April 2022 and for MASH in the US (August 2025) and Canada (conditional, December 2025).
• Emcure Pharmaceuticals distributes semaglutide in India under the brand name Poviztra, with a significant price reduction effective 3 April 2026.
• Approximately two-thirds of India's population are estimated to have fatty liver disease.
• MASH is linked to metabolic disorders such as obesity, type 2 diabetes, and dyslipidaemia.