India Unveils Worlds First NorUDCA Drug, NODUCA

Following the historic approval granted in August 2025 by India’s Central Drugs Standard Control Organization (CDSCO), Shilpa Medicare has launched NODUCA (Nor Ursodeoxycholic Acid, or norUDCA), the first medication of its kind to be introduced in India or anywhere in the world.

This breakthrough therapy opens a new treatment avenue for patients with metabolic dysfunction–associated fatty liver disease (MAFLD), previously known as NAFLD.

NorUDCA delivers three key therapeutic benefits: it provides strong anti-inflammatory effects that help prevent progression to cirrhosis and liver failure, with Phase 3 trials showing fibrosis reversal in 83.3% of patients and normalization of liver enzyme levels in 90% within just three months; it offers choleretic protection by enhancing bile flow, promoting toxin elimination, and safeguarding cholangiocytes; and it addresses inflammation, fibrosis, and cholestasis through mechanisms distinct from conventional treatments.

Also Read: Zydus Secures USFDA Nod for Leuprolide Acetate Injection

Together, these actions position NODUCA™ as a first-in-class, innovative therapy aimed at significantly improving liver health in individuals with MAFLD.

The Central Drugs Standard Control Organisation (CDSCO), operating under the Directorate General of Health Services in the Ministry of Health & Family Welfare, serves as India’s National Regulatory Authority (NRA).

Headquartered at FDA Bhawan on Kotla Road, New Delhi 110002, the organisation also functions through six zonal offices, four sub-zonal offices, thirteen port offices, and seven laboratories across the country. Under the Drugs & Cosmetics Act of 1940 and the Rules of 1945, both central and state regulators are assigned specific responsibilities to oversee the regulation of drugs and cosmetics.