The regulatory shutdown was issued on August 20 by the Central Drugs Standard Control Organisation and Assam drug controllers. It followed a July precautionary recall by the drugmaker that encompassed 332 batches across roughly 11 eye-care brands, including Lotepred, Nepalact OD, and Brinzotim. Patient infections prompted a June safety advisory from the All India Ophthalmological Society concerning contaminated batches of Predmet eye drops. A formal compliance report has been submitted by the company and remains under official review before manufacturing can restart.
Key points
Manufacturing at the intended sterile production hub cannot resume until regulators fully…: Manufacturing at the intended sterile production hub cannot resume until regulators fully review and approve the compliance report.
The affected ophthalmic treatments potentially total hundreds of thousands of bottles int…: The affected ophthalmic treatments potentially total hundreds of thousands of bottles intended for managing eye inflammation and infections.
While ophthalmic products comprise roughly 3% of domestic revenue, the drugmaker has not…: While ophthalmic products comprise roughly 3% of domestic revenue, the drugmaker has not publicly commented on the shutdown.
Sources checked by our analysis pipeline: 1
The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on August 20 after a joint federal-state inspection of the facility identified lapses in the system meant to ensure product quality and safety, following Sun Pharma's move in July to voluntarily recall about 11 eye-care brands.
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India's drug quality standards have come under increased scrutiny at home and overseas in recent years after locally made cough syrups were linked to the deaths of children in India and also in countries including Gambia and Uzbekistan.
The regulatory agencies' move marks an escalation of the action against Sun Pharma, India's biggest pharmaceutical firm, which will be unable to continue ophthalmic drug production at the Assam factory until it submits a satisfactory compliance report. Sun Pharma said previously the site was expected to become one of its largest manufacturing hubs for sterile products in a business identified as a key global growth driver.
The regulator sought more information on the recall…
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