New Delhi: Tamil Nadu’s drug regulator has found no contamination in samples of Chennai-manufactured eye drops that have been linked to infections, blindness and even deaths by a US medical watchdog.
The director of Tamil Nadu Drugs Control, P.V. Vijayalakshmi, has said no contamination was found in the samples from unopened eye drops made by Chennai-based Global Pharma Healthcare.
The regulator was quoted by NDTV as saying: “Samples from several batches, including the one under question, were analysed. We found no contamination. The raw materials too were found as per standards.”
US’ Centers for Disease Control and Prevention (CDC) flagged the eye drops or artificial tears as being contaminated with an antibiotic resistant form of aggressive bacteria “Pseudomonas aeruginosa”.
The bacteria type Pseudomonas is found in the environment, with P. aeruginosa being the most common to cause infections in humans.
More than 10 different brands of artificial tears have been recalled so far. “Most cases have been linked to EzriCare and Delsam Pharma eye drops, made by Global Pharma Healthcare,” said abcnews.
According to latest reports, the death toll of the outbreak is three, and at least eight people have gone blind and four people have had their eyeballs surgically removed.
In February, Global Pharma voluntarily recalled entire lots of the artificial tears lubricant eye drop “due to possible contamination”.
The US’ Food and Drugs Administration (FDA) had noted around that time that the “use of contaminated artificial tears can result in the risk of eye infections that could result in blindness”. Artificial tear drops are used as a protectant against irritation or to relieve dryness of the eye.
The FDA visited a Global Pharma Healthcare facility in India for an inspection after the company recalled EzriCare Artificial Tears.
The report published recently said the manufacturer did not follow proper protocol to prevent contamination of its products, according to CNN.
“An 11-day inspection of the Global Pharma facility resulted in 11 observations by the FDA, including a ‘manufacturing process that lacked assurance of product sterility,’ specifically for batches of product that were manufactured between December 2020 and April 2022 and shipped to the US,” the report said.
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