Artificial Tears Lubricant eye drops are used as a protectant against irritation
New Delhi:
The health ministry found the samples of eyedrops manufactured by Chennai-based Global Pharma Healthcare to be of “standard quality”, sources have said.
PV Vijayalakshmi, the Director of the Tamil Nadu Drugs Control, also said it found “no contamination” in samples of eyedrops after the top medical watchdog in the US raised concerns over its use.
The Centers for Disease Control and Prevention (CDC) has linked the eyedrops to the likelihood of a highly drug-resistant bacteria gaining a foothold in the US.
Citing the US medical watchdog, The New York Times earlier reported that three deaths, eight cases of blindness and dozens of infections had been traced to eyedrops under the brand name EzriCare Artificial Tears.
Infectious disease specialists said this drug-resistant bacteria strain had not been previously detected in the US and was particularly difficult to treat with the antibiotics currently available, the newspaper reported.
Global Pharma Healthcare, located about 40 km south of Chennai, had stopped the production of the eyedrops after the US Food and Drug Administration (USFDA) had raised a red flag over its use.
USFDA had earlier said using contaminated artificial tears increases risk of eye infections that could result in blindness or death.
The drugmaker has also initiated the recall of 50,000 tubes of eye ointment in the US market.
Stating the reason for recall, the US health regulator said: “FDA analysis found unopened tubes to be contaminated with bacteria.”
The Tamil Nadu drugs regulator had then found “no evidence of deviation” at the Chennai plant in February.
The India-made brand of eyedrops were the latest pharmaceutical product from the country to land under scrutiny after dozens of deaths among children in Gambia and Uzbekistan last year linked to cough syrups.
The bacteria, pseudomonas aeruginosa, can cause infections in the blood, lungs or wounds and the germ has been proving tougher to treat in recent times because of antibiotic resistance, experts have said.
Artificial Tears Lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.