NEW DELHI: ‘No contamination’ was found from the samples of eye drops manufactured by India’s Global Pharma Healthcare, which were linked to three deaths and blindness in some patients in the US, said health ministry sources on Tuesday.
According to official sources, the samples of the eye drops were found to be “free of any contamination."
The Centers for Disease Control and Prevention (CDC), the top medical watchdog in the US, has linked the eyedrops manufactured by Chennai-based pharma company to the likelihood of a highly drug-resistant bacteria gaining a foothold in the US.
The New York Times, quoting CDC, reported that three deaths, eight cases of blindness, and dozens of infections have been traced to the eyedrops made by Global Pharma Healthcare under the brand name EzriCare Artificial Tears.
The Drug Controller General of India (DCGI) has also formally written a letter to USFDA, though USFDA has not yet communicated to DCGI, sources added.
A joint inspection was also conducted by Central Drugs Standard Control Organization (CDSCO) and Tamil Nadu state drugs inspectors on Tuesday at the manufacturing unit and the manufacturing has been kept on hold till the completion of the investigation.
Earlier, in February, USFDA warned the consumers not to purchase or use EzriCare Artificial Tears due to potential contamination. Using contaminated artificial tears can increase the risk of eye infections that could result in blindness or death. Following the warning, Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and of all unexpired lots Delsam Pharma’s Artificial Tears.
Indian drug inspectors – both central and state - had conducted an inspection at the company premises which is 40 km south of Chennai and asked the pharma company to halt all manufacturing in February.