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HYDERABAD, Oct 30: Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failure in \u200bits quality management system, documents reviewed by Reuters showed.<\/strong><\/p>\n The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on \u200cAugust 20 after a joint federal-state inspection of the facility identified lapses in the system meant to ensure product quality and safety, following Sun Pharma\u2019s move in July to voluntarily recall about 11 eye-care brands.<\/p>\n India\u2019s drug quality standards have come under increased scrutiny at home and overseas in recent years after locally made cough syrups were linked to the deaths of children in India and also in countries including Gambia and \u200bUzbekistan.<\/p>\n The regulatory agencies\u2019 move marks an escalation of the action against Sun Pharma, India\u2019s biggest pharmaceutical firm, which will be unable to continue ophthalmic drug production at the Assam \u200bfactory until it submits a satisfactory compliance report. Sun Pharma said previously the site was expected to become one of its largest manufacturing \u2060hubs for sterile products in a business identified as a key global growth driver.<\/p>\n The regulator sought more information on the recall of 332 batches of ophthalmic suspension products \u2014 liquids \u200bused to treat eye conditions \u2014 the documents showed.<\/p>\n In an internal notice sent to stockists at the time, the company said it was withdrawing the products as a \u201cprecautionary measure.\u201d It remains unclear \u200bwhether all of the recalled products were contaminated.<\/p>\n Sun Pharma did not publicly disclose details of the recall.<\/p>\n The company has submitted a compliance report in response to the order, which is being reviewed by the regulator, an official familiar with the matter told Reuters on condition of anonymity because they were not authorised to speak to the media.<\/p>\n Sun Pharma did not respond to Reuters\u2019 requests for comment on the Assam \u200bplant and the recall. The company says on its website it follows a single global quality standard.<\/p>\n Some of the recalled products included \u200bLotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. The eye drops are used to treat eye inflammation, infections and chronic eye diseases, according to doctors.<\/p>\n It \u200cis unclear whether these \u2060eye products were exported from India or whether any patients reported any adverse effects.<\/p>\n Reuters found that, based on the product packaging, most of the recalled products were manufactured at the Assam state facility in Kokjhar village. Reuters could not independently verify whether the 332 batches cited by regulators were related only to the 11 identified brands in the recall notice or included additional brands.<\/p>\n The affected batches could translate into hundreds of thousands of eye-drop bottles, according to industry experts, who declined to be identified because they were not authorised to speak publicly.<\/p>\n Ophthalmology \u200bcontributes about 3% of Sun Pharma\u2019s domestic revenue, according \u200bto its 2025-26 annual report. It is \u2060also one of its key areas for the US.<\/p>\n The company reported a drop in second-quarter profit on Friday weighed down by a one-time charge related to its acquisition of US-based Organon.<\/p>\n The eye product recall coincided with a patient-safety advisory issued in June by the All India \u200bOphthalmological Society (AIOS), an independent body of eye specialists, warning that certain batches of Predmet eye drops appeared to be contaminated.<\/p>\n \u201cThere were some \u200badverse cases of infections \u2060reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated,\u201d Santosh Honavar, a doctor and secretary of AIOS, told Reuters, adding that Sun Pharma had also recalled those Predmet drops.<\/p>\n Sun Pharma did not respond to Reuters\u2019 request for comment on the AIOS advisory.<\/p>\n The regulators issued a show-cause notice to Sun Pharma on August 10, citing the quality \u2060management system \u200bfailures, the documents showed.<\/p>\n Dissatisfied with the company\u2019s response, the regulators ordered a halt to the manufacturing, sale and \u200bdistribution of all ophthalmic products from the facility.<\/p>\n Indian regulators did not respond to Reuters\u2019 requests for comment. The agency did not issue a public health alert after the recall.<\/p>\n It is not the first time Sun Pharma\u2019s sterile \u200bmanufacturing facilities have faced regulatory scrutiny. Last year, the US FDA halted the company\u2019s shipments from Gujarat\u2019s Halol plant after inspectors cited shortcomings in contamination controls.<\/p>\n<\/div>\nRECALL COULD INVOLVE HUNDREDS OF THOUSANDS OF BOTTLES<\/strong><\/h3>\n