New Delhi– The US Centers for Disease Control and Prevention (CDC) has flagged concern over the use of an Indian eye drop that is causing death and blindness among its citizens.
However, the Tamil Nadu Drugs Control said there is no contamination, according to media reports.
The CDC has, in recent months, traced three deaths, eight cases of blindness and dozens of infections caused by a highly drug-resistant bacteria linked to Chennai-based EzriCare artificial tears, made by Global Pharma Healthcare, The New York Times reported.
Drug-resistant bacteria Pseudomonas aeruginosa has been a cause of concern among people with weak immune systems, residents of nursing homes and patients using catheters and breathing tubes.
In February, Global Pharma Healthcare had recalled and stopped the production of both EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. And the US Food and Drug Administration (FDA) had instructed doctors and consumers not to purchase the product from the market and warned those who have already purchased not to use it.
The warning issued by the FDA read, “using contaminated artificial tears increases risk of eye infections that could result in blindness and death”.
However, the CDC said it was concerned that the bacteria could gain a foothold in the US, as the bacteria showed signs of spreading among asymptomatic patients, in a Connecticut care centre, who had the bacteria colonised in their bodies.
Such spread tends to occur when patients touch common items or when health care workers transmit the germs.
According to experts, pseudomonas is very hard to get rid of.
“Pseudomonas is especially difficult to eradicate, both from health care facilities, where it clings tenaciously to sink drains, water faucets and other moist environments, and from patients who develop bloodstream infections”, David van Duin, an infectious disease specialist at the University of North Carolina School of Medicine, was quoted as saying.
After the FDA had issued the warning in February, a group of drug inspectors from the Central and Tamil Nadu governments conducted an inspection at the company premises which is 40 km south of Chennai.
While refusing to comment on the FDA’s remarks on the eyedrops, the Tamil Nadu drug regulator now said it found “no contamination” in samples of eye drops manufactured by Global Pharma, media reports said.
This is the third such incident where an Indian pharmaceutical product has come under scrutiny.
Last year, dozens of deaths were reported among children in Gambia and Uzbekistan allegedly due to Indian cough syrups.
Cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals were linked to deaths of at least 70 children in Gambia, while Delhi-based Marion Biotech’s cough syrups were linked to the deaths of 18 children in Uzbekistan. (IANS)