Indian regulator halts Sun Pharma eye-drop output at Assam plant

what happened

Indian drug regulators have ordered Sun Pharmaceutical Industries, the country's largest drugmaker, to halt manufacturing, sales and distribution of all ophthalmic products made at its Assam facility. According to documents reviewed by Reuters, the Central Drugs Standard Control Organisation and the Assam Drugs Controller issued the order on August 20, after a joint inspection found serious gaps in the company's quality management system. Earlier, in July, Sun Pharma voluntarily recalled around 11 eye-care brands and all ophthalmic products from the plant. Regulators have also requested more information on 332 batches of ophthalmic suspensions.

Sun Pharma said it voluntarily paused production and informed the regulators, adding that remedial steps are in place. The company has filed a report on corrective measures, which the regulator is now reviewing. Production can resume only after regulators accept that report.

Separately, the company reported a lower second-quarter profit, partly due to a one-time charge linked to its acquisition of US-based Organon.

why it matters

For investors, the key question is the scale of the impact. According to the company's annual report for 2025-26, ophthalmology accounts for about 3% of its domestic revenue, though the segment also matters in the US market. It remains unclear whether all recalled batches were contaminated or whether any were exported.

market impact

Sun Pharma shares: risk of delayed restart and pressure on its eye-care segment

• ▼Sun Pharma shares pressure down — halted eye-drop production and batch recalls create operational and reputational risks

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