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 gastroenterology and hepatology to assess whether obeticholic acid should continue to be sold in India after global regulators, including the Food and Administration (USFDA) and the European Medicines Agency, recommended revocation of the drug’s authorization due to risks of serious liver injury and a lack of confirmed clinical efficacy.
“Obeticholic acid 5mg/10mg tablets approved by the CDSCO on 11.03.2020 are being marketed in the country for primary biliary cholangitis. However, the European Medicines Agency, in its press release dated 28.06.2024, has recommended that obeticholic acid’s marketing authorization be revoked, because its benefits are no longer considered to outweigh its risks,” read the 10 November directive.
“The drug has also been withdrawn from the US market after the FDA request dated 12.09.2025. The reasons for withdrawal in the US and the European Union were failure to show efficacy and serious liver injury in some patients,” the document said.
The directive also referred to the global assessment of Ocaliva, the drug’s innovator brand. “As per the published global regulatory review, the clinical benefits of innovator products have not been confirmed. In particular, study 747-302 failed to show that Ocaliva (innovator) was more effective than placebo (a dummy treatment) in terms of the number of patients whose disease worsened or who died, both in the overall population and in a group of patients with early-stage PBC,” the document said.
The regulator added that supplementary evidence did not alter the assessment of the trial outcome. “It was also considered that the data from supportive studies and real-world data were not sufficient to confirm the benefits of Ocaliva and could not counterbalance the negative results of study 747-302,” the document added.
Pharmaceutical industry experts questioned the regulatory delay. “Once the USFDA and European Medicines Agency stopped the drug over serious safety risks and even halted clinical trials, what prevented the subject expert committee from acting for more than a year?,” asked Uday Bhaskar, former director general at Pharmaceuticals Export Promotion Council of India (Pharmexcil).
“While around 10 to 11 manufacturers continued making the API (active pharmaceutical ingredient) and formulations here, stocks remained in the market for patients to consume. Moreover, how effective this recall will actually be across the country remains a big question mark,” he added.
Generic versions of obeticholic acid are marketed in India by several companies, including Cipla Ltd, Zydus Lifesciences Ltd, Alkem Laboratories Ltd and Natco Pharma Ltd. Mint‘s queries sent to the Union health ministry, CDSCO, Cipla, Zydus, and Alkem on Thursday, and to Intercept Pharmaceuticals and Natco Pharma on Friday, remained unanswered.
Medical specialists advised that patients currently on the medication should seek medical evaluation rather than stop treatment without guidance. “The drug can cause severe itching, worsening liver function and, in some patients, serious liver injury, including liver failure. While stopping the medicine does not typically cause withdrawal symptoms, the underlying liver disease, PBC, continues to require treatment and monitoring,” said Sharad Malhotra, senior consultant and director, Gastroenterology, Hepatology and Therapeutic Endoscopy, Aakash Healthcare.
He further added that the priority now must be to ensure that affected patients receive timely medical guidance, appropriate alternative therapies and regular follow-up, while strengthening regulatory vigilance to prevent such delays in future.
