CDSCO Orders Sun Pharma to Halt Eye-Care Drug Production Over Quality Lapses

Indian drug regulators ordered Sun Pharmaceutical Industries to suspend the manufacturing, sale, and distribution of ophthalmic products at its Assam facility following the identification of quality management system lapses. According to reviewed documents, the Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam issued the directive on August 20 following a joint federal-state inspection. The regulatory action follows Sun Pharma's voluntary recall of approximately 11 eye-care brands in July, which involved 332 batches of ophthalmic suspension products.

Regulatory Action and Voluntary Recall

The joint inspection identified shortcomings in the systems designed to ensure product safety and quality at the Kokjhar village facility in Assam. Regulators issued a show-cause notice on August 10 and subsequently ordered the production halt after finding the company's response unsatisfactory. The plant will remain unable to manufacture ophthalmic products until it submits a compliance report that satisfies regulatory review.

• Affected Products: Included brands such as Lotepred 1% 5ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5ml, and Depopred 2ml.
• Scale: Industry experts estimate the recalled batches could comprise hundreds of thousands of bottles.
• Company Response: Sun Pharma stated in an internal notice that the recall was a precautionary measure. An official reported that the company has submitted a compliance report currently under review by regulators.

Context and Patient Safety Advisories

The recall coincided with a June patient-safety advisory from the All India Ophthalmological Society (AIOS), which warned of contamination in certain batches of Predmet eye drops. AIOS officials stated that investigated sealed bottles showed contamination, prompting a recall of those specific drops. It remains unclear whether all recalled products were contaminated or if exports and patient adverse effects occurred, as regulators did not issue a public health alert.

• Verification: Stakeholders can review official regulatory circulars and company notifications to verify enforcement updates.
• Implications: Ophthalmology accounts for approximately 3% of Sun Pharma's domestic revenue and represents a key growth sector for its US business.