Regulators order Sun Pharma to halt eye-care production at Assam plant
The Central Drugs Standard Control Organisation and Assam drug regulators identified quality management deficiencies at the facility.
Indian drug regulators have directed Sun Pharmaceutical Industries to stop the manufacturing, sale, and distribution of ophthalmic products from its Assam facility. According to reports by Mint and The Hindu, the order was issued on August 20 following a joint inspection by central and state drug regulators.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller, Assam, took this action after finding deficiencies in the company's quality management system. This follows a show-cause notice issued to the firm on August 10 regarding similar shortcomings.
Sun Pharma had previously moved to voluntarily recall approximately 11 eye-care brands and all ophthalmic products from the site in July. The company stated in an internal notice to stockists that the withdrawal was a "precautionary measure."
Regulators are currently seeking additional information regarding the recall of 332 batches of ophthalmic suspension products. These liquid formulations are used to treat various eye conditions, including inflammation and infections.
The company cannot resume ophthalmic drug production at the Kokjhar village plant until regulators review and accept its compliance report. Sun Pharma said in a statement 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.