Regulators order Sun Pharma to stop ophthalmic production at Assam plant
The Central Drugs Standard Control Organisation and Assam drug regulators identified quality management deficiencies at the facility.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller, Assam, ordered Sun Pharmaceutical Industries to halt the manufacturing, sale, and distribution of ophthalmic products at its Assam facility on August 20. This directive followed a joint inspection by central and state regulators that identified failures in the plant's quality management system.
The order comes after the company voluntarily recalled approximately 11 eye-care brands and all ophthalmic products from the site in July. Sun Pharma previously described the withdrawal as a "precautionary measure" in a notice to stockists.
Regulators have requested further information regarding the recall of 332 batches of ophthalmic suspension products, which are liquid formulations used for eye conditions. The company has submitted a compliance report detailing corrective measures, which is currently being reviewed by authorities.
Sun Pharma cannot resume ophthalmic drug production at the Kokjhar village plant until regulators accept its compliance report. The company stated on Friday that it had initiated a temporary cessation of manufacturing and implemented remedial measures.
The recalled brands include Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml, and Depopred 2ml. It remains unclear if the products were contaminated or if any patients reported adverse effects.