Indian regulators have ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its facility in Assam after a joint inspection found failures in the plant’s quality management system, according to documents reviewed by Reuters.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam issued the order on August 20 following an inspection of the facility at Kokjhar village. The action came after Sun Pharma voluntarily recalled about 11 eye-care brands in July and regulators sought information on 332 batches of ophthalmic suspension products.
The recalled products included Lotepred 1% 5ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5ml eye drops and Depopred 2ml. These medicines are used for eye inflammation, infections and chronic eye conditions. Reuters reported that the number of affected batches could represent hundreds of thousands of bottles, although the exact volume was not established in the documents reviewed.
The regulators had issued a show-cause notice to Sun Pharma on August 10, citing failures in the quality management system. The agencies were dissatisfied with the company’s response and subsequently ordered a halt to manufacturing, sale and distribution of all ophthalmic products from the facility. Production can resume only after the company submits a compliance report considered satisfactory by the regulators.
Sun Pharma has submitted a compliance report, which was being reviewed by the regulator, an official familiar with the matter told Reuters on condition of anonymity because the official was not authorised to speak to the media. Sun Pharma did not respond to Reuters’ requests for comment on the Assam plant and recall. The company has previously said that the facility was expected to become one of its largest manufacturing hubs for sterile products.
It remains unclear whether all the recalled products were contaminated, whether the products were exported from India or whether patients reported adverse effects from the recalled batches. Reuters also could not independently establish whether the 332 batches cited by regulators related only to the 11 brands named in the recall notice or included additional products.
The recall followed a June patient-safety advisory from the All India Ophthalmological Society, an independent body of eye specialists, concerning certain batches of Predmet eye drops. Santosh Honavar, a doctor and AIOS secretary, told Reuters that infections had been reported in some patients and that sealed bottles investigated by doctors were found to be contaminated. Sun Pharma had also recalled the Predmet drops, according to the report.
The regulatory action adds to scrutiny of India’s pharmaceutical quality systems, following cases in which locally manufactured cough syrups were linked to child deaths in India, Gambia and Uzbekistan. Sun Pharma’s sterile manufacturing operations have also faced overseas regulatory action: the US Food and Drug Administration halted shipments from its Gujarat plant in Halol last year after inspectors cited shortcomings in contamination controls.
The Indian regulators did not issue a public health alert after the Assam recall, and the agencies did not respond to Reuters’ requests for comment. The review of Sun Pharma’s compliance report will determine whether the production, sale and distribution restrictions on ophthalmic products from the facility are lifted.
