New Delhi, Nov. 14 -- India's apex drug regulator has ordered an immediate halt to the manufacturing, sale, and distribution of obeticholic acid tablets and directed companies to recall the chronic liver disease medication pending a fresh safety review, according to two officials and a document seen by Mint.

The Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi has sought the cancellation of manufacturing licences for obeticholic acid (5mg and 10mg tablets), approved in India in March 2020 to treat primary biliary cholangitis (PBC), following recommendations from the Central Drugs Standard Control Organisation's (CDSCO) subject expert panel on gastroenterology and hepatology.

The regulator had referred the matter to its ...