Indian Regulator Orders Halt and Recall of Obeticholic Acid Due to Liver Injury Risk

India's Drugs Controller General (DCGI) has mandated an immediate halt to the manufacturing, sale, and distribution of obeticholic acid tablets, used for chronic liver disease, and ordered a recall. This decision follows recommendations from an expert panel and similar actions by global regulators, including the US FDA and European Medicines Agency, citing risks of serious liver injury and unconfirmed efficacy.