According to recent reports, the US Food and Drug Administration has raised concerns about the Indian eye drops manufacturer, Global Pharma, for its product EzriCare Artificial Tears Eye Drop, which allegedly caused blindness in some people.
The US Food and Drug Administration has found a series of violations in the manufacturing process and sterilisation methods adopted by Global Pharma, the Indian manufacturer of an eye drop that has been linked to 68 cases of eye infection in America, including eight cases of vision loss and three deaths.
The company recalled its product, EzriCare Artificial Tears Eye Drop, early in February. The over-the-counter product has been linked to a highly drug-resistant and rare bacterial infection.
From February 20 till March 3, a team of the US FDA inspected the Alathur plant of Global Pharma in Tamil Nadu.
The report, accessed by Scroll, lists several lapses at the plant that indicate that the eye drops might have been contaminated during the manufacturing stage.
The US drug inspectors found that the Indian manufacturer skipped vital tests to check for microbial growth in the drug, did not test active pharmaceutical ingredients and packaging material to ensure sterility, and failed to maintain an aseptic, pathogen-free environment in its plant.
“The US FDA takes its responsibility seriously to ensure the medical products the American public relies on meet our rigorous standards for quality, safety and effectiveness,” Jeremy Kahn, FDA press officer, told Scroll. “This issue continues to be an ongoing compliance matter.”
Scroll sent an email to Global Pharma, seeking its response to the report. This story will be updated if the company responds.
Doctors in the journal Medical Mycology Case Reports said that an Indian man is the world’s first human to be infected with the deadly plant fungus Chondrostereum purpureum.
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