Medicines regulator halts production of obetic acid, withdraws orders

India’s top drug regulator ordered an immediate halt to the production, sale and distribution of obeticholic acid tablets and ordered companies to withdraw the chronic liver disease drug pending a new safety review, according to two officials and a document seen by Mint.

Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi has requested the cancellation of manufacturing licenses for obeticholic acid (5 mg and 10 mg tablets), approved in India in March 2020 for the treatment of primary biliary cholangitis (PBC), in line with the recommendations of the Central Drug Standard Control Organization (CDSCO) industry panel on gastroenterology and gastroenterology.

The regulator referred the matter to its gastroenterology and hepatology experts to assess whether obeticholic acid should continue to be sold in India after global regulators, including the US Food and Drug Administration (USFDA) and the European Medicines Agency, recommended revoking the drug’s authorization due to the risk of serious liver damage and lack of confirmed clinical efficacy.

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“Obeticholic acid 5mg/10mg tablets approved by 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 recommended that the marketing authorization for obeticholic acid be revoked as it already outweighs its benefits.

“The drug was also withdrawn from the US market following a request by the FDA on 12/09/2025. The reason for the withdrawal in the US and the European Union was a lack of evidence of efficacy and serious liver damage in some patients,” the document states.

Global security

The guideline also referred to the global evaluation of Ocaliva, the drug’s innovator brand. “According to a published global regulatory review, the clinical benefits of the innovator products have not been confirmed. In particular, study 747-302 did not show that Ocaliva (the innovator) was more effective than placebo (a dummy treatment) in terms of the number of patients who got worse or died, both in the overall population and in the early-stage PBC group,” the document states.

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The regulator added that the additional evidence did not change the assessment of the court’s outcome. “It was also considered that the data from the supporting studies and the real-world data were insufficient to confirm the benefits of Ocaliva and could not offset the negative results of the 747-302 study,” the document added.

Pharmaceutical industry experts questioned the regulatory delay. “Once the USFDA and the European Medicines Agency stopped the drug due to serious safety risks and even stopped the clinical trials, what prevented the expert panel in question from acting for more than a year?” asked Uday Bhaskar, former CEO of the Pharmaceuticals Export Promotion Council of India (Pharmexcil).

“While about 10 to 11 manufacturers continued to manufacture API (active pharmaceutical ingredient) and formulations here, the stock remained in the market for patients to consume. Moreover, a big question mark remains how effective this recall will be across the country,” 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. The mint’s queries sent to the Union health ministry, CDSCO, Cipla, Zydus and Alkem on Thursday and Intercept Pharmaceuticals and Natco Pharma on Friday remained unanswered.

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Doctors recommended that patients currently taking medication seek medical evaluation rather than stopping treatment without guidance. “The drug can cause severe itching, deterioration of liver function and in some patients severe liver damage, including liver failure. Although stopping the drug usually does not cause withdrawal symptoms, the underlying liver disease, PBC, still requires 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 advice, appropriate alternative therapies and regular follow-up, while strengthening regulatory vigilance to avoid such delays in the future.