Sun Pharma Ordered To Halt Eye Drug Output At Assam Plant

Drug regulators flagged quality management failures at the Assam facility, with restrictions covering the manufacture, sale and distribution of ophthalmic products

Drug regulators have ordered Sun Pharmaceutical Industries to halt the manufacture, sale and distribution of ophthalmic products from its Assam facility after identifying lapses in its quality management system. The 20 August order followed a joint inspection by central and state authorities and the company's voluntary recall of around 11 eye-care brands in July.

The action by the Central Drugs Standard Control Organisation (CDSCO) and the Office of the Drugs Controller, Assam, requires Sun Pharma to demonstrate compliance with quality standards before resuming ophthalmic drug production at the facility. The extent of potential contamination and the impact on patients remain unclear, according to Reuters report.

Regulators Flag Quality Management Lapses

The regulatory action followed a joint inspection of Sun Pharma's Assam manufacturing facility by the CDSCO and the state drug control authority. The inspection identified deficiencies in the systems designed to en...