TN Pharma company directed to stop manufacturing of eye drops

CHENNAI: Based on an alert from the US Food and Drugs Administration, the State Drug Controller has directed a Tamil Nadu based Pharma company to stop manufacturing eye drops since their samples were found to be infected with bacteria.

FDA 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. The Central Drugs Standard Control Organisation (CDSCO) also conducted an inquiry along with the State Drug Controller officials and directed the company to stop manufacturing all the products for eye use until the investigation was over.

The officials from the State drug Controller said that FDA alert was issued based on a finding that the eye drop is infected with a drug resistant bacteria that can result in permanent vision loss.

State Drug Controller Dr P V Vijayalakshmi said that we have taken the samples and sent them to the concerned authorities. "We are also running the tests on raw materials used for making the eye drop and tests are being conducted in King Institute. The results are awaited. There seems to have been infected with the particular bacteria in the open containers. The samples from the sealed containers have also been taken and reports from CDSCO are awaited. Once the CDSCO gives a report, they will be sharing the report with us based on the findings," she said.

While the company did not have stocks of the batches manufactured in 2021 and 2022 that were exported to the USA, the control samples of those were available and have been tested. The state authorities are testing all the available samples. The company had earlier stated that they are withdrawing the lots of eye drops/artificial tears manufactured by them and distributed by Ezricare, LLC and Delsam Pharma, due to the possible contamination.