File image for representation. , Photo credit: PV Shivakumar
The absence of a warning or communication from the United States’ Centers for Disease Control and Prevention (CDC) or the Food and Drug Administration (USFDA) to India highlights their concern that a drug-resistant bacterial strain may have been reported from the eye drops. Attached to imported eyes. India’s Drugs Controller General of India (DCGI) has written to the USFDA seeking details on its case on Tuesday, health ministry sources said, adding that India could have gained a foothold in US health care settings.
US public health bodies raised the alarm after the USFDA said the maker of EzriCare eye drops – Chennai-based Global Pharma Healthcare – is recalling 50,000 tubes from the US market following reports of contamination.
The source further said that Global Pharma Healthcare has been directed to stop production of ophthalmic products till the completion of the investigation.
“So far, the samples taken from the company have been found free of contamination,” the source said, adding, “The samples were taken by a joint central-state team and the results have been shared with the department concerned. Preliminary Reportedly, the samples are free of contamination. Reports of alleged contamination in the United States have come from unopened bottles. The eye drops are distributed in the US market by New York-based Delsum Pharma.”
Sources in the State Drug Control Department said that the raw material used to make the eye drops was found to be of standard quality. “We are closely monitoring the investigation and taking the matter forward,” the official said.
Earlier this year, ErziCare artificial tears were linked to more than 50 reports of adverse events in 12 states in the US, including eye infections, permanent loss of vision, and death due to bloodstream infection. After this, Global Pharma Healthcare recalled the product manufactured by it.
Previously, the CDC cautioned that patients should stop using the eye drops pending additional information and guidance from the CDC and FDA. The CDC said it had made no recommendations for testing patients who had used the product and who were not experiencing any signs or symptoms of infection. It states that symptoms of an eye infection may include yellow, green or clear discharge from the eye; pain or discomfort; redness of the eye or eyelid; feeling of something in your eye (foreign body sensation); increased sensitivity to light; and blurred vision.