Sun Pharma Ordered to Stop Eye-Drug Production at Assam Plant Over Quality Concerns

Indian drug regulators have directed Sun Pharmaceutical Industries to halt the manufacture, sale and distribution of all ophthalmic products produced at its Assam facility after identifying serious deficiencies in its quality management system.

The Central Drugs Standard Control Organisation (CDSCO) and the Assam Drugs Controller issued the order on August 20 following a joint inspection. The action came after the company voluntarily recalled around 11 eye-care brands in July, with regulators seeking clarification regarding 332 batches of ophthalmic suspension products.

The recalled medicines included Lotepred 1% eye drops, Nepalact OD, Nepalact-Z, Brinzotim and Depopred. The company had described the recall as a precautionary measure, but it remains unclear whether all affected products were contaminated or whether patients suffered adverse effects.

Sun Pharma said it had temporarily suspended manufacturing activities voluntarily and implemented corrective measures. Its compliance report has been submitted to regulators and is under review. Production at the facility cannot resume until the authorities receive a satisfactory compliance report.

The development comes amid growing scrutiny of pharmaceutical manufacturing standards in India. Sun Pharma has also faced regulatory concerns at its Halol facility in Gujarat, where US authorities halted shipments last year over shortcomings in contamination controls.