Regulators order Sun Pharma to halt eye-drop 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 facility in Assam. According to reports by Mint and The Hindu, the Central Drugs Standard Control Organisation and the office of the Drugs Controller, Assam, issued the order on August 20.
The directive follows a joint inspection by central and state regulators that identified failures in the company's quality management system. This action comes after Sun Pharma voluntarily recalled approximately 11 eye-care brands and all ophthalmic products from the site in July as a precautionary measure.
Regulators have requested further information regarding the recall of 332 batches of ophthalmic suspension products, which are liquid formulations used for eye conditions. The recalled brands include Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml, and Depopred 2ml.
Sun Pharma stated on Friday that it had voluntarily initiated a temporary cessation of manufacturing and had implemented remedial measures. The company has submitted a compliance report outlining corrective actions, which regulators are currently reviewing.
The pharmaceutical company cannot resume ophthalmic drug production at the Assam plant until the regulators examine and accept its compliance report. Most of the affected medicines were manufactured at the company's facility in Kokjhar village.