Indian drug regulators have ordered Sun Pharmaceutical Industries to halt the manufacturing, sale, and distribution of all ophthalmic products from its Assam facility. This decisive action, taken on August 20, stems from identified failures within the plant's quality management system, following a joint central-state inspection.
Regulatory Action and Recall Details
The Central Drugs Standard Control Organisation (CDSCO) and the office of the Drugs Controller Assam issued the directive after a show-cause notice on August 10. This order prevents Sun Pharma, India's largest pharmaceutical company, from resuming ophthalmic drug production at the facility until its compliance report is accepted by regulators.
The regulatory scrutiny intensified after Sun Pharma voluntarily recalled approximately 11 eye-care brands and all ophthalmic products from the Assam facility in July. Regulators are seeking more information regarding 332 recalled batches of ophthalmic suspension products, which are liquids used for various eye conditions. While the company stated it initiated the withdrawal as a "precautionary measure" and has implemented remedial actions, it did not publicly disclose comprehensive details of the recall.
Affected Products and Patient Safety Concerns
- Recalled Brands: Products like Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml, and Depopred 2ml were among those withdrawn. These are commonly used to treat eye inflammation, infections, and chronic eye diseases.
- Scale: Industry experts suggest the affected batches could amount to hundreds of thousands of eye-drop bottles.
- Contamination: It remains unclear if all recalled products were contaminated, whether they were exported, or if patients reported adverse effects.
Adding to concerns, the recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society (AIOS). The independent body of eye specialists warned of contamination in certain batches of Predmet eye drops, with reports of adverse infections in patients. Sun Pharma reportedly also recalled those Predmet drops.
Previous Scrutiny and Company Response
This is not the first instance of regulatory scrutiny for Sun Pharma's sterile manufacturing facilities. Last year, the US Food and Drug Administration (FDA) halted shipments from the company's Halol plant in Gujarat due to shortcomings in contamination controls.
Sun Pharma has stated that it "voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," emphasizing that remedial measures are in place. The company's compliance report is currently under review by regulators. Ophthalmology contributes approximately 3% of Sun Pharma's domestic revenue and is a key area for the company in the US market.
"We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," Sun Pharma said in a statement, adding that remedial measures had been put in place.
The company maintains on its website that it adheres to a single global quality standard across its operations.