NEW DELHI (Reuters) – No contamination was found in samples of eye drops made by India’s Global Pharma Healthcare, a product linked to three deaths and blindness in some patients in the U.S., broadcaster NDTV reported on Tuesday citing India’s health ministry sources.
Indian tests found the samples to be of “standard quality”, the report said, nearly two months after U.S. agencies warned against using the Artificial Tears eye drops, citing potential contamination by drug-resistant bacteria.
Spokespeople for India’s health ministry and Global Pharma Healthcare Pvt Ltd did not immediately respond to a request for comment.
The company issued a nationwide voluntary recall of the product in February due to possible contamination, according to the U.S. Food and Drug Administration (FDA), which said the firm had violated good manufacturing practices.
The U.S. Centers for Disease Control and Prevention (CDC) had identified the presence of “a rare strain of extensively drug-resistant” bacteria in 68 patients in 16 states, most of whom reported using Artificial Tears eye drops, as of March 14.
At least three people have died, and there have been eight reports of vision loss and four reports of surgical removal of an eyeball, according to the CDC.
The incident follows the deaths of at least 70 children in Gambia and 19 children in Uzbekistan last year that were linked to Indian-made cough syrups, which hurt the country’s image as the “pharmacy of the world”.
(Reporting by Shivam Patel in New Delhi, Editing by Louise Heavens and Bernadette Baum)
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