India orders top drugmaker to halt eye medicine production at plant over quality lapses
Indian regulators have ordered Sun Pharmaceutical Industries to halt production of ophthalmic drugs at its Assam facility due to quality management failures. The shutdown follows a voluntary recall of several eye-care brands and a joint federal-state inspection.
Why it matters
This regulatory action highlights ongoing concerns regarding the quality control standards of major Indian pharmaceutical exporters, which are critical to global supply chains.
Indian regulators have escalated action against India's largest drugmaker, Sun Pharma, barring ophthalmic drug production at its Assam factory until it submits a satisfactory compliance report.
A guard walks inside the office of Sun Pharmaceutical Industries Ltd in Mumbai, India, Nov 13, 2018. (Photo: Reuters/Francis Mascarenhas)
HYDERABAD: Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failure in its quality management system, documents reviewed by Reuters showed.
The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on Aug 20 after a joint federal-state inspection of the facility identified lapses in the system meant to ensure product quality and safety, following Sun Pharma's move in July to voluntarily recall about 11 eye-care brands.
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