Artificial Tears Lubricant eye drops are used as a protectant against irritation
The samples of eye drops made by Chennai-based Global Pharma Healthcare - linked to three deaths and blindness in the US, are of "standard quality", sources in the Health Ministry told NDTV today. The result of the samples, taken during a joint inspection by Tamil Nadu's Drug Controller and Central Drugs Standard Control Organisation in February, "came in favour of Global Healthcare private limited," they added.
However, just to be "on the safe side", the pharmaceutical company was asked to "halt the production of the eye drops", they said, nearly two months after the US Centres for Disease Control and Prevention- a top medical watchdog in America - warned against using the Artificial Tears eye drops, citing potential contamination by drug-resistant bacteria.
The Health Ministry sources also said that US Food and Drug Administration (USFDA) is America's drug regulator and not the CDC. "The USFDA has not said anything about the Artificial Tears product till now and the Drugs Controller General of India is awaiting their response," they said.
Global Pharma Healthcare, about 40 km south of Chennai, issued a nationwide voluntary recall of the product in February after the US health agency had identified the presence of "a rare strain of extensively drug-resistant" bacteria in 68 patients in 16 states.
The pharma company, at the same time, "voluntarily" recalled the eye drops which were sent to America, even as the Indian drug controllers did not ask it to withdraw the same, said the sources.
Earlier in the day, Tamil Nadu's drug regulator also said it found "no contamination" in samples of eye drops.
The director of the Tamil Nadu Drugs Control PV Vijayalakshmi has said no contamination was found in samples from unopened eye drops manufactured by the Chennai plant. "Samples from several batches, including the one under question, were analysed. We found no contamination. The raw materials too were found as per standards," the drug regulator's director said.
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 a report, citing the CDC.