Indian drug regulators have ordered Sun Pharmaceutical Industries (SUNPHARMA) to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failures in its quality management system.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam issued the shutdown order on August 20, following a joint federal-state inspection that identified lapses in the systems meant to ensure product quality and safety. The inspection followed Sun Pharma’s decision in July to voluntarily recall about 11 eye-care brands.
The order marks an escalation of regulatory action against India’s largest drugmaker, which will be unable to resume ophthalmic production at the site until it submits a satisfactory compliance report. Sun Pharma has previously said the plant was expected to become one of its largest manufacturing hubs for sterile products, part of a business it has identified as a key driver of global growth.
The regulators had issued a show-cause notice on August 10 citing the quality management failures. Dissatisfied with the company’s response, they ordered a halt to manufacturing, sale and distribution of all ophthalmic products from the facility. They also sought further information on the recall of 332 batches of ophthalmic suspension products, liquids used to treat eye conditions.
In an internal notice sent to stockists at the time, Sun Pharma described the withdrawal as a “precautionary measure.” It is unclear whether all of the recalled products were contaminated. The company did not publicly disclose details of the recall, and Indian regulators did not issue a public health alert.
Sun Pharma has submitted a compliance report, which is being reviewed, according to an official familiar with the matter who was not authorized to speak publicly. The company said in a statement that it had voluntarily initiated a temporary cessation of manufacturing activities, informed the regulators and put remedial measures in place. It did not respond to a request for comment on the recall. Its website says it follows a single global quality standard.
The recalled products included Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml, which doctors say are used to treat eye inflammation, infections and chronic eye diseases. Based on product packaging, reporting found that most were made at the facility in Kokjhar village in Assam. It could not independently verify whether the 332 batches related solely to the 11 brands named in the recall notice or included others. Industry experts said the affected batches could amount to hundreds of thousands of eye-drop bottles. It is unclear whether any of the products were exported or whether patients reported adverse effects.
The recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society, which warned that certain batches of Predmet eye drops appeared to be contaminated. Santosh Honavar, a doctor and secretary of the society, said adverse infection cases were reported in patients who used Predmet and that tests on sealed bottles found contamination. He said Sun Pharma had also recalled those drops. The company did not respond to a request for comment on the advisory.
Ophthalmology accounts for about 3 per cent of Sun Pharma’s domestic revenue, according to its 2025-26 annual report, and is also a key area for the company in the US. Sun Pharma recently reported a drop in second-quarter profit, weighed down by a one-time charge related to its acquisition of US-based Organon (OGN).
The case adds to scrutiny of Indian drug quality at home and abroad, after locally made cough syrups were linked to child deaths in India, Gambia and Uzbekistan. It is not the first time Sun Pharma’s sterile manufacturing sites have drawn regulatory attention: last year the US Food and Drug Administration halted shipments from the company’s Halol plant in Gujarat after inspectors cited shortcomings in contamination controls.