Ophthalmic products recalled: Why drug regulators ordered Sun Pharma to halt eye-drop production at Assam plant?
Indian drug regulators have directed Sun Pharmaceutical Industries, the country's largest pharmaceutical company, to stop manufacturing, selling and distributing ophthalmic products produced at its Assam facility after identifying significant deficiencies in its quality management system.
According to documents reviewed by Reuters, the Central Drugs Standard Control Organisation (CDSCO) and the office of the Drugs Controller, Assam, issued the order on August 20 following a joint inspection by central and state drug regulators.
The action came after Sun Pharma voluntarily recalled around 11 eye-care brands, along with all ophthalmic products manufactured at the facility, in July. The regulators have also sought additional information concerning 332 batches of recalled ophthalmic suspension products.
In an internal notice sent to stockists at the time, Sun Pharma said it was withdrawing the products as a "precautionary measure."
The regulatory action followed a show-cause notice issued to Sun Pharma on August 10, highlighting shortcomings in its quality management system.
After examining the company's response, the authorities were not satisfied with the explanations provided and subsequently ordered the suspension of manufacturing, sale and distribution of all ophthalmic products from the facility.
The directive also means that Sun Pharma cannot restart ophthalmic drug production at the Assam plant until regulators examine and accept its compliance report.
The company has submitted a report outlining the corrective measures undertaken to address the identified deficiencies. An official familiar with the matter told Reuters that the regulator is currently reviewing the submission.
The regulators have sought further details regarding the recall of 332 batches of ophthalmic suspension products. These are liquid formulations commonly prescribed for treating various eye conditions.
"We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," Sun Pharma said in a statement on Friday, adding that remedial measures had been put in place.
The recalled brands include Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml.
According to doctors, these medicines are used to manage eye inflammation, infections and chronic ophthalmological conditions.
Product packaging indicates that most of the affected medicines were manufactured at Sun Pharma's facility in Kokjhar village in Assam.
Industry experts estimate that the affected batches could involve hundreds of thousands of bottles of eye drops, reported Reuters.
Several questions surrounding the recall remain unanswered. It is not yet clear whether all the recalled products were contaminated, whether any of the affected batches were exported or whether patients reported adverse effects after using the medicines.
The regulatory documents reviewed by Reuters do not establish that contamination occurred across all recalled batches.
The developments come at a time when Sun Pharma is facing pressure on its financial performance. The company's ophthalmology business accounts for approximately 3% of its domestic revenue, according to its annual report for 2025-26. The segment is also among its important business areas in the US market.
Sun Pharma reported a decline in its second-quarter profit on Friday, partly due to a one-time charge associated with its acquisition of US-based Organon.
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