Now Reading: DCGI halts obeticholic acid production, orders recall
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DCGI halts obeticholic acid production, orders recall
The Story in Brief
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. The Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi has sought the cancellation of manufacturing licences for the drug, approved in India in March 2020 to treat primary biliary cholangitis (PBC), following recommendations from the CDSCO's expert panel on gastroenterology and hepatology.
The regulator acted after global regulators including the USFDA and European Medicines Agency recommended revoking the drug’s authorization due to risks of serious liver injury and a lack of confirmed clinical efficacy. Generic versions of obeticholic acid are marketed in India by Cipla Ltd, Zydus Lifesciences Ltd, Alkem Laboratories Ltd and Natco Pharma Ltd. Medical specialists advised that patients currently on the medication should seek medical evaluation rather than stop treatment without guidance.
Pharmaceutical industry experts questioned the regulatory delay. Uday Bhaskar, former director general at Pharmexcil, asked what prevented the expert committee from acting for more than a year after global regulators stopped the drug over safety risks.
Indian Opinion Analysis
The DCGI’s recall order, more than two years after the European Medicines Agency recommended revocation, exposes a gap in India’s drug safety surveillance. Around 10 to 11 domestic manufacturers were producing the active ingredient and formulations while global regulators had already flagged serious liver injury risks. The effectiveness of the recall across India remains uncertain, as the former Pharmexcil director noted. For patients, the key immediate step is to consult a doctor for alternative therapies and monitoring, not to stop treatment abruptly.
Source: livemint.com
This brief was synthesised by AI from the source linked above. Methodology and corrections.
