海得拉巴：印度药品监管机构已责令太阳制药工业公司停止生产、销售和分销其阿萨姆邦工厂生产的眼科产品，此前监管机构发现该工厂的质量管理体系存在缺陷，路透社查阅的文件显示。
HYDERABAD: Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failure in its quality management system, documents reviewed by Reuters showed.
中央药品标准控制组织和阿萨姆邦药品监管局于8月20日下令关停该工厂，此前联邦和邦两级联合检查组对该设施进行检查，发现旨在确保产品质量和安全的体系存在疏漏，此次检查是在太阳制药于7月自愿召回约11个眼科护理品牌之后进行的。
The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on Aug 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's move in July to voluntarily recall about 11 eye-care brands.
近年来，印度制造的止咳糖浆与印度以及冈比亚、乌兹别克斯坦等国儿童死亡事件有关联，导致印度的药品质量标准在国内外面临更严格的审视。
India's 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 Uzbekistan.
监管机构的这一举措标志着针对印度最大制药企业太阳制药的行动升级，除非提交令人满意的合规报告，否则该公司将无法继续在阿萨姆邦工厂生产眼科药物。
The regulatory agencies' move marks an escalation of the action against Sun Pharma, India's biggest pharmaceutical firm, which will be unable to continue ophthalmic drug production at the Assam factory until it submits a satisfactory compliance report.
太阳制药此前曾表示，该工厂预计将成为其无菌产品最大的制造中心之一，而无菌产品业务被视为关键的全球增长驱动力。
Sun Pharma said previously the site was expected to become one of its largest manufacturing hubs for sterile products in a business identified as a key global growth driver.
文件显示，监管机构要求提供关于召回332批眼科混悬剂产品（用于治疗眼部疾病的液体制剂）的更多信息。
The regulators sought more information on the recall of 332 batches of ophthalmic suspension products - liquids used to treat eye conditions - the documents showed.
据当时发送给经销商的内部通知，公司称撤回产品是“预防性措施”。目前尚不清楚所有被召回产品是否均受到污染。太阳制药未公开披露召回的详细情况。
In an internal notice sent to stockists at the time, the company said it was withdrawing the products as a "precautionary measure." It remains unclear whether all of the recalled products were contaminated. Sun Pharma did not publicly disclose details of the recall.
一位知情官员在接受路透社采访时表示，因未获授权对媒体发言，该官员要求匿名，公司已针对该命令提交合规报告，监管机构正在审查中。
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.
Sun Pharma未回应路透社就阿萨姆邦工厂及召回事件提出的置评请求。该公司在其网站上称，遵循单一的全球质量标准。
Sun Pharma did not respond to Reuters' requests for comment on the Assam plant and the recall. The company says on its website it follows a single global quality standard.
召回或涉及数十万瓶产品 部分被召回产品包括洛替泼德1% 5毫升眼药水、奈帕酮OD眼药水、奈帕酮-Z、溴莫尼定眼药水5毫升和地泼尼松2毫升。据医生介绍，这些眼药水用于治疗眼部炎症、感染和慢性眼病。
RECALL COULD INVOLVE HUNDREDS OF THOUSANDS OF BOTTLES Some of the recalled products included Lotepred 1 per cent 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.
目前尚不清楚这些眼科产品是否从印度出口，也不知是否有患者报告不良反应。
It is unclear whether these eye products were exported from India or whether any patients reported any adverse effects.
一名男子在印度孟买举行的新闻发布会上走过一块屏幕，会上宣布Sun Pharma收购美国公司Organon，摄于2026年4月27日。
A man walks past a screen during a press conference announcing Sun Pharma's acquisition of US company, Organon in Mumbai, India, Apr 27, 2026.
路透社根据产品包装发现，大多数被召回产品产自阿萨姆邦科克贾尔村的工厂。路透社无法独立核实监管机构引用的332个批次是否仅涉及召回通知中确定的11个品牌，还是还包含其他品牌。
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.
据行业专家称，受影响批次可能相当于数十万瓶眼药水，这些专家因未获授权公开发言而拒绝透露姓名。
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.
根据其2025-26年度报告，眼科业务贡献了Sun Pharma国内收入的约3%。这也是其在美国的重点领域之一。
Ophthalmology contributes about 3 per cent of Sun Pharma's domestic revenue, according to its 2025-26 annual report. It is also one of its key areas for the United States.
该公司周五（10月30日）报告称，第二季度利润下滑，主要受收购美国Organon公司相关的一次性费用拖累。
The company reported a drop in second-quarter profit on Friday (Oct 30) weighed down by a one-time charge related to its acquisition of US-based Organon.
此次眼科产品召回与全印度眼科学会（AIOS）于6月发布的一份患者安全建议同时发生，该独立眼科专家机构警告称，某些批次的泼尼松龙眼药水疑似受到污染。
The eye product recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society (AIOS), an independent body of eye specialists, warning that certain batches of Predmet eye drops appeared to be contaminated.
“我们收到一些使用Predmet（泼尼松龙）患者出现不良感染病例的报告，随后对密封瓶进行了检测，发现受到污染，”全印度眼科协会（AIOS）秘书、医生Santosh Honavar对路透社表示，并补充说，Sun Pharma（太阳制药）也已召回那些Predmet眼药水。
"There were some adverse cases of infections reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated," Santosh Honavar, a doctor and secretary of AIOS, told Reuters, adding that Sun Pharma had also recalled those Predmet drops.
Sun Pharma未回应路透社关于AIOS警示的置评请求。
Sun Pharma did not respond to Reuters' request for comment on the AIOS advisory.
文件显示，监管机构于8月10日向Sun Pharma发出了说明原因通知，理由是质量管理体系失效。
The regulators issued a show-cause notice to Sun Pharma on Aug 10, citing the quality management system failures, the documents showed.
对公司的回复不满意，监管机构下令停止该工厂所有眼科产品的生产、销售和分销。
Dissatisfied with the company's response, the regulators ordered a halt to the manufacturing, sale and distribution of all ophthalmic products from the facility.
印度监管机构未回应路透社的置评请求。该机构在召回后未发布公共卫生警示。
Indian regulators did not respond to Reuters' requests for comment. The agency did not issue a public health alert after the recall.
这并非Sun Pharma的无菌生产设施首次面临监管审查。去年，美国食品药品监督管理局（FDA）在检查人员指出污染控制存在缺陷后，叫停了该公司古吉拉特邦Halol工厂的发货。
It is not the first time Sun Pharma's sterile manufacturing facilities have faced regulatory scrutiny. Last year, the US FDA halted the company's shipments from Gujarat's Halol plant after inspectors cited shortcomings in contamination controls.