India halts Sun Pharma eye-drop production at Assam plant over quality lapses
Regulators have barred India's largest drugmaker from making eye medicines in Assam until it files a satisfactory compliance report.
Indian drug regulators have ordered Sun Pharmaceutical Industries to stop making, selling and distributing eye-care products from its plant in Assam, according to documents reviewed by Reuters and reported by The Straits Times, CNA and The Hindu.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam issued the order on August 20. A joint federal-state inspection had found failures in the facility's quality management system. The regulators sent a show-cause notice on August 10 and, dissatisfied with the reply, halted all ophthalmic output from the site. Production cannot resume until Sun Pharma, India's biggest pharmaceutical company, submits a satisfactory compliance report.
The outlets differ on the company's response. The Hindu reported a Sun Pharma statement on Friday saying: "We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators." The company added that remedial measures were in place. The Straits Times and CNA reported that Sun Pharma did not respond to Reuters' requests for comment on the plant or the recall.
The order followed a voluntary recall in July of about 11 eye-care brands, which the company told stockists was a "precautionary measure". Regulators sought more information on the recall of 332 batches of ophthalmic suspension products. Reuters could not confirm whether those batches covered only the 11 brands. Unnamed industry experts said they could amount to hundreds of thousands of bottles.
Recalled products included Lotepred 1% 5ml, Nepalact OD, Nepalact-Z, Brinzotim 5ml and Depopred 2ml, used for eye inflammation, infections and chronic eye disease. Reuters found from packaging that most were made at the Assam facility in Kokjhar village. It is unclear whether the products were exported, whether patients reported adverse effects or whether all of them were contaminated. Regulators issued no public health alert and did not respond to requests for comment.
In June the All India Ophthalmological Society warned that some batches of Predmet eye drops appeared contaminated. Its secretary, Santosh Honavar, told Reuters there "were some adverse cases of infections reported in patients who used Predmet" and that tests on sealed bottles confirmed contamination. He said Sun Pharma had recalled those drops too.
India's drug standards have faced scrutiny since locally made cough syrups were linked to children's deaths in India, Gambia and Uzbekistan. In 2025 the US FDA halted shipments from Sun Pharma's Halol plant in Gujarat over shortcomings in contamination controls.
Sun Pharma had said the Assam site was expected to become one of its largest sterile manufacturing hubs. Ophthalmology makes up about 3% of its domestic revenue and is a focus area in the US. On Friday the company reported lower second-quarter profit, weighed down by a one-time charge tied to its purchase of US-based Organon. Its compliance report is under review by the regulator, an official told Reuters.
Sources: The Straits Times, India orders Sun Pharma to halt eye-care drug production at plant after quality lapses; CNA, India orders top drugmaker to halt eye medicine production at plant over quality lapses; The Hindu, India orders Sun Pharma to halt eye-care drug production at plant after quality lapses.
