CDC finds no containment in eye drops manufactured by pvt TN firm

CHENNAI: After the State Drugs Control Department directed a State-based Pharma company to stop manufacturing eye drops since their samples were found to be infected with bacteria based on an alert from the US Food and Drugs Administration, further investigations by Centers for Disease Control and Prevention found no contamination.

Earlier, the FDA had linked the death of one person and infections in about 55 people due to the use of Ezricare Artificial Tears, manufactured by Global Pharma Healthcare.

After an initial inquiry by the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller officials, the company was asked to stop the manufacturing and distribution until the results. The company had recalled the mentioned eye drops after the same and stopped the distribution of the artificial tear eye drops.

FDA had issued an alert based on a report that the eye drop is infected with drug resistant bacteria and it poses a risk to the eye vision. However, the further investigations of the control samples of the eye drop that were transported to the USA were done.

State Drug Controller Dr P V Vijayalakshmi said that the samples did not reveal any contamination upon testing and the final instructions are awaited on resuming the manufacturing of the eye drops. "Several samples including the product samples manufactured in 2021 and 2022 were tested for any strain of the bacteria and the samples were found to be of standard quality," an official from the State Drug Control Department said.

The results revealed that the eye drops are of standard quality and the raw materials were also of proper quality. Meanwhile, the US Food and Drug Administration (USFDA) is yet to issue a response on the same.