Indian drug regulators have halted Sun Pharma’s manufacture, sale and distribution of ophthalmic medicines from the company’s plant in Assam after deficiencies were found in its quality management system. Reuters reports this, citing regulatory documents.
The decision was made on 20 August after the company voluntarily recalled around eleven drug brands in July.
The authorities have requested additional information about the recall, which covers 332 manufacturing batches and, according to industry experts, could correspond to hundreds of thousands of bottles.
Sun Pharma has submitted a corrective action report, which is now being reviewed by the authorities.
Production may not resume until the deficiencies have been rectified.
Ophthalmic medicines account for around 3 percent of the company’s domestic revenue.
