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Indian regulators bar Sun Pharma eye-drug production at Assam factory

Indian regulators barred Sun Pharma from producing ophthalmic drugs at its Assam factory until it submits a satisfactory compliance report.

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Cropped view of part of a Sun Pharma sign on a stone wall, with a uniformed guard partly visible at the right.
Detail of a Sun Pharma sign. This photograph does not establish the location of the Assam factory or depict the regulatory action.

Indian regulators barred Sun Pharma, India's largest drugmaker, from producing ophthalmic drugs at its Assam factory until it submits a satisfactory compliance report. The restriction concerns medicines for the eyes.

The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on August 20. A joint federal-state inspection found lapses in the system intended to ensure product quality and safety, following the company's voluntary July recall of about 11 eye-care brands.

Regulators had issued Sun Pharma a show-cause notice on August 10, citing failures in its quality management system.

Dissatisfied with the company's response, regulators ordered manufacturing, sales and distribution of all ophthalmic products from the facility to stop.

In an internal notice to stockists, the company described its withdrawal of products as a precautionary measure. Whether all the recalled products were contaminated remains unclear.