Eye drops samples taken for testing

Chennai-based company flagged by US authorities

After a Chennai-based pharmaceutical company was flagged by US authorities over lethal contamination in eye drops, officials of Tamil Nadu’s Drug Controller and Central Drug Control Authority conducted a late-night inspection of manufacturing premises of Global Pharma Healthcare Private Limited, sources said.

During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of ‘Artificial Tears’ to the USA which were manufactured in 2021 and 2022, added the sources.

“The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken,” added the sources.

Central Drugs Standard Control Organization (CDSCO) has barred the manufacturing of EzriCare Artificial Tears at the Chennai-based firm after US FDA alleged adverse events due to the use of eyedrops, said a statement yesterday.

US regulator Food and Drug Administration warned consumers “not to purchase or use Chennai-based manufacturer EzriCare Artificial Tears due to potential contamination”, added the statement.

Probe initiated

The CDSCO and Tamil Nadu State Drug Controller have initiated a probe into the matter, a source aware of the issue said on Friday.

The investigation has been started after the Centre for Disease Control and Prevention (CDC) published a report that the artificial tears manufactured and supplied by Global Healthcare Private limited had reported adverse events, including eye infections, permanent loss of vision and death with a bloodstream infection.