India orders Sun Pharma to halt eye-drop production at Assam plant after quality failures
Indian drug regulators have ordered Sun Pharmaceutical Industries to stop making, selling and distributing eye medicines produced at its Assam plant, after finding failures in the factory’s quality management system. Reuters reported the order on Friday, 30 October 2026, citing documents it reviewed.
The Central Drugs Standard Control Organisation and the Assam Drugs Controller issued the order on 20 August, after inspecting the plant at Kokjhar village. It followed a July recall of about 11 eye-care brands by Sun Pharma, and a show-cause notice on 10 August. Regulators said they were not satisfied with the company’s reply.
Regulators have also asked for more information about 332 batches of the eye medicines. The recalled products include Lotepred 1% 5ml, Nepalact OD, Nepalact-Z, Brinzotim 5ml and Depopred 2ml eye drops. Industry experts told Reuters the batches could amount to hundreds of thousands of bottles, though it is unclear if all were contaminated.
Concerns had surfaced in June, when the All India Ophthalmological Society warned some batches of Predmet eye drops appeared contaminated. Its secretary, Dr Santosh Honavar, told Reuters that users had reported infections and sealed bottles tested were found contaminated.
Sun Pharma, India’s biggest drugmaker, has submitted a report on its corrective steps, which regulators are reviewing. Production cannot restart until they accept it. In a statement on Friday, the company said: “We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators.” It did not respond to Reuters’ questions about the recall.
No public health alert was issued after the recall, and it is not clear whether any recalled medicines were exported. Eye medicines account for about 3 per cent of Sun Pharma’s domestic revenue.
Why it matters
Eye drops go directly into the eye, so a failure in how they are made carries a clear risk of infection and eye damage. The episode also adds to scrutiny of India’s drug industry after locally made cough syrups were linked to children’s deaths in India, The Gambia and Uzbekistan.
For Sun Pharma, the halt hits a business it had called a key growth area: the Assam site was expected to become one of its largest hubs for sterile products.
What happens next
Regulators are now reviewing Sun Pharma’s compliance report. If they accept it, production of eye medicines at the Assam plant can restart; if not, the halt stays in place.
This article is for general information and education only. It is not legal or financial advice.
Sources
- https://wncy.com/2026/10/30/exclusive-india-orders-sun-pharma-to-halt-eye-care-drug-production-at-plant-after-quality-lapses/ (Reuters via WNCY, 30 October 2026)
- https://dailythedestination.com/india-orders-sun-pharma-to-halt-eye-drug-production-over-quality-failures/ (The Destination, 31 October 2026)
