Regulators halt Sun Pharma eye-drop production at Assam plant

India's drug regulators have ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing eye-care products made at its plant in Assam, after an inspection found failures in the system meant to guarantee product quality, Reuters reported on Friday, citing documents it had reviewed.

The order was issued on August 20 by the Central Drugs Standard Control Organisation (CDSCO) and the office of the Drugs Controller, Assam, following a joint central and state inspection of the facility. It came after the company voluntarily recalled about 11 eye-care brands in July. The action had not been made public until now.

What the regulators found

According to the report, the regulators issued a show-cause notice to Sun Pharma on August 10 over failures in its quality management system. Not satisfied with the reply, they ordered a halt to all ophthalmic production, sale and distribution from the site. Production cannot resume until the company submits a compliance report that the regulator accepts.

An official told the agency that Sun Pharma has filed such a report and that it is under review. The regulator also asked for more details on the recall of 332 batches of ophthalmic suspensions, which are liquid medicines used for eye conditions. Industry experts estimated the batches could amount to hundreds of thousands of bottles.

The recalled products

Products named in the recall included Lotepred 1% eye drops, Nepalact OD, Nepalact-Z, Brinzotim eye drops and Depopred, used for eye inflammation, infections and chronic eye disease. Based on the packaging, most were made at the Assam plant in Kokjhar village. The company told stockists at the time that the withdrawal was a precautionary measure. It is not clear whether all the recalled batches were contaminated, whether any were exported, or whether patients reported side effects.

Separately, the All India Ophthalmological Society (AIOS), an independent body of eye specialists, issued a patient-safety advisory in June about certain batches of Predmet eye drops. Its secretary told Reuters that infections had been reported in patients who used the drops, that sealed bottles tested by the society were found contaminated, and that Sun Pharma had recalled those batches too.

Why it matters for Assam

Sun Pharma has described the Assam site as set to become one of its largest hubs for sterile products, a business it sees as a key growth area. Eye-care products make up about 3% of its domestic revenue. The company did not respond to Reuters' requests for comment, and the regulators also did not comment. CDSCO did not issue a public health alert after the recall.

The report adds to scrutiny of Indian drug quality after cough syrups made in the country were linked to child deaths at home and abroad. Last year the US Food and Drug Administration halted shipments from Sun Pharma's Halol plant in Gujarat over contamination-control lapses.

Patients who use eye drops from these brands and have concerns should consult their doctor or pharmacist rather than stop prescribed treatment on their own.