India-Made Eye Drops Linked To Deaths In US Have 'No Contamination,' Says Report

NEW DELHI: 'No contamination' has been found in eye drops made in Chennai by Global Pharma Healthcare that have been linked to three deaths and blindness in some patients in the United States have, news agencies said Tuesday, citing a report from union health ministry sources. The report said tests showed samples of the eye drops are of 'standard quality'.

This comes days after the US' Food and Drug Administration (FDA) said the Chennai-based firm was recalling 50,000 tubes of the lubricant due to 'bacterial contamination'.

On February 24, Global Pharma Healthcare initiated a voluntary Class I recall of the product for artificial tear drops used to protect against irritation or to relieve dryness of the eye.

A Class I recall is the most urgent and is usually reserved for defective products that can cause serious health problems, FDA regulations say.

According to reports, last month patients in the United States were asked by FDA to immediately stop using the product after over 50 reports of 'adverse events' including eye infections and permanent vision loss. One death had been linked to use of the eye drops at that time.

In the latest case, the US’ Centre for Disease Control and Prevention (CDC) said it is testing unopened bottles of EzriCare Artificial Tears eye drops, the product at the centre of the controversy.

At the time FDA said in its statement, “FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death.”

The CDC further said that patients reportedly displayed a variety of conditions - from eye infections to blood poisoning, often called sepsis, the CDC said. The infections are caused by a rare strain of Pseudomonas aeruginosa bacteria that is resistant to many commonly used antibiotics and had not been previously seen in the United States,.

An investigation by Tamil Nadu's Drug Controller and Central Drug Control Authority was prompted by the FDA action, which led to the agency conducting a late-night inspect of the manufacturing premises and taking samples for analysis.

The eye drops are the latest pharmaceutical product from India to be mired in a global controversy over possible contamination, after Haryana-based Maiden Pharmaceuticals and Noida-based Marion Biotech cough syrups were reported to have caused deaths of children in The Gambia and Uzbekistan.

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