Sun Pharma halts Assam eye-drug production after India quality order

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Sun Pharma halts Assam production

Highlights

Sun Pharmaceutical Industries is ordered by India's regulators on August 20 to halt manufacturing, sales, and distribution of ophthalmic products from its Assam facility after quality system failures.
Regulators are reviewing Sun Pharma's compliance report following the precautionary recall of 332 batches of ophthalmic suspension products, including Lotepred, Nepalact OD, Brinzotim, and Depopred eye drops.
Ophthalmology, contributing about 3% of Sun Pharma's domestic revenue, faces business disruption amid increased quality scrutiny and previous U.S. FDA action against the company's Halol sterile plant.

Regulatory action follows recall and inspection

As first reported by Reuters, India's Central Drugs Standard Control Organisation and the office of Drugs Controller Assam order Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after a joint inspection finds failures in its quality management system.

The shutdown order is issued on August 20, after regulators send a show-cause notice on August 10 and then deem the company's response unsatisfactory, according to documents reviewed by Reuters. Sun Pharma submits a compliance report in response to the order, and that filing is under regulatory review, an official familiar with the matter tells Reuters.

The documents also show regulators seek more information on the recall of 332 batches of ophthalmic suspension products, liquids used to treat eye conditions. In an internal notice to stockists at the time, the company says it withdraws the products as a precautionary measure, while it remains unclear whether all of the recalled products are contaminated.

Some of the recalled products include Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. Reuters finds from product packaging that most of the recalled products are manufactured at the Assam facility in Kokjhar village, although it cannot independently verify whether the 332 batches cited by regulators relate only to the 11 identified brands or also include additional brands.

Business impact grows amid wider quality scrutiny

Sun Pharma, India's biggest pharmaceutical company, cannot continue ophthalmic drug production at the Assam factory until it submits a satisfactory compliance report. The site was previously expected by the company to become one of its largest manufacturing hubs for sterile products, a business it identifies as a key global growth driver.

Industry experts say the affected batches could amount to hundreds of thousands of eye-drop bottles. Ophthalmology contributes about 3% of Sun Pharma's domestic revenue, according to its 2025-26 annual report, and the segment is also one of its key focus areas for the U.S.

The recall coincides with a June patient-safety advisory from the All India Ophthalmological Society, which warns that certain batches of Predmet eye drops appear to be contaminated. Santosh Honavar, doctor and secretary of AIOS, tells Reuters that some adverse infection cases are reported in patients who use Predmet and that testing of sealed bottles finds contamination, adding that Sun Pharma also recalls those drops.

It remains unclear whether the affected eye products are exported from India or whether any patients report adverse effects linked to the wider recalled portfolio. The latest action also adds to earlier scrutiny of Sun Pharma's sterile manufacturing operations after the U.S. FDA last year halts shipments from the company's Halol plant in Gujarat over shortcomings in contamination controls.

NAFDAC’s crackdown on unsafe and counterfeit regulated products in Nigeria highlighted how regulators are stepping up enforcement to protect consumers and tighten oversight across the supply chain. In our earlier coverage, we noted that the agency destroyed falsified and non-compliant goods worth N22.73 billion in the first eight months of the year, underscoring rising compliance risks for importers, distributors, and retailers.

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