India Halts Sun Pharma Eye Drug Output Over Quality Fears

Indian drug regulators have mandated Sun Pharmaceutical Industries to halt the production, sale, and distribution of all ophthalmic products originating from its facility in Assam. This stringent measure, implemented on August 20, stems from identified failures within the company's quality management system, as revealed by documents reviewed by Reuters. The order came after a joint inspection by the Central Drugs Standard Control Organisation and the Drugs Controller Assam.

This regulatory action escalates oversight for Sun Pharma, India's largest pharmaceutical company. The Assam facility, previously earmarked as a significant manufacturing hub for sterile products and a key global growth driver, will remain non-operational for ophthalmic drugs until a satisfactory compliance report is submitted. This situation arises subsequent to Sun Pharma's voluntary recall in July of about 11 eye-care brands, impacting 332 batches of ophthalmic suspension products.

Details regarding the extent of contamination in the recalled products remain unclear, though the company cited a "precautionary measure." Industry experts estimate the affected batches could amount to hundreds of thousands of eye-drop bottles. This event occurs amid heightened scrutiny of India's drug quality standards, following international concerns linked to locally manufactured cough syrups. Furthermore, an independent body of eye specialists issued an advisory in June concerning potential contamination in certain batches of Predmet eye drops, which Sun Pharma also recalled.

Sun Pharma, which noted that ophthalmology constitutes approximately 3% of its domestic revenue, has submitted a compliance report that regulators are currently reviewing. The company has faced previous regulatory challenges, including a halt on shipments from its Gujarat facility by the US FDA last year due to shortcomings in contamination controls.