Regulators order Sun Pharma to halt eye-care production at Assam plant
The Central Drugs Standard Control Organisation and Assam Drugs Controller ordered a shutdown following quality management failures.
Indian drug regulators have ordered Sun Pharmaceutical Industries to stop the manufacturing, sale, and distribution of ophthalmic products from its facility in Assam. According to reports by Business Today and The Hindu, the order was issued on August 20 after a joint inspection by the Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam identified lapses in quality and safety systems.
The regulatory action follows Sun Pharma's July decision to voluntarily recall approximately 11 eye-care brands. Regulators have requested further details regarding the recall of 332 batches of ophthalmic suspension products, which are liquid medications used for eye treatments.
Sun Pharma stated on Friday that it had voluntarily initiated a temporary halt to manufacturing and implemented remedial measures. The company has submitted a compliance report, which is currently being reviewed by regulators. Production at the Assam site cannot resume until the regulators accept this report.
The recall includes brands such as Lotepred 1% 5ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5ml, and Depopred 2ml. While the company described the withdrawal as a precautionary measure, it has not publicly disclosed specific details regarding the recall or whether the products were contaminated.
The Assam facility in Kokjhar village was intended to be a major manufacturing hub for sterile products for the company. Ophthalmology currently accounts for about 3 per cent of Sun Pharma's domestic revenue.