Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its facility in Assam after finding a failure in its quality management system, Reuters reported on Friday, October 30, citing documents it had reviewed.
Source: Reuters
The Central Drugs Standard Control Organisation (CDSCO) and the office of the Drugs Controller Assam issued the order on August 20, after a joint federal-state inspection of the facility at Kokjhar village identified lapses in the system meant to ensure product quality and safety. The order had not been publicly disclosed before Reuters reported it on October 30.
The regulatory action followed Sun Pharma's move in July to voluntarily recall about 11 eye-care brands as a precautionary measure. Regulators also sought more information on the recall of 332 batches of ophthalmic suspension products, the documents showed. Products named in the recall included Lotepred 1% 5ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5ml eye drops and Depopred 2ml.
According to the documents reviewed by Reuters, the regulators had first issued a show-cause notice to the company on August 10, citing the quality management system failures, and ordered the halt after they were dissatisfied with its response. Production at the Assam facility can resume only after Sun Pharma submits a compliance report that regulators find satisfactory.
Sun Pharma, India's biggest pharmaceutical company, said in a statement on Friday: "We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," adding that remedial measures have been put in place. An official familiar with the matter told Reuters the company has submitted a compliance report, which is being reviewed by the regulator.
It remains unclear whether all of the recalled products were contaminated, Reuters reported, and the drug regulators did not issue a public health alert after the recall and did not respond to requests for comment. The eye-product recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society, an independent body of eye specialists, warning that certain batches of Predmet eye drops appeared to be contaminated.
Ophthalmology products contribute about 3 per cent of Sun Pharma's domestic revenue, according to its 2025-26 annual report, Reuters said. What happens next depends on the regulator's review of the company's compliance report, which will decide whether the restrictions on the Assam plant's eye-care products are lifted.