India launches investigation into eye drops linked to vision loss in the US
by The Canadian Parvasi
India’s Central Drugs Standard Control Organisation (CDSCO) has reportedly called off the manufacturing of eye drops produced by a Chennai-based firm after the drops were linked to 55 cases of adverse events, reportedly due to the drops being contaminated, by the US FDA.
Chennai-based Global Pharma Private Healthcare Limited was the firm that manufactured ‘EzriCare Artificial Tears’, a type of eyedrop that the Food and Drug Administration in the US has since cautioned users “not to purchase or use.”
“Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the FDA cautioned in a statement.
Global Pharma has initiated a voluntary recall of all the unexpired stock of the eyedrops, according to media reports.
The contract-supplying plant reportedly supplied through others to the US market. The eye drops in question are not sold in India, media outlets report.
Additionally, all import of eye drops in the US has been halted by the FDA, which is reportedly also instructing practitioners in the nation to not prescribe the eye drops.
The eye drops were cautioned to be recalled by the FDA reportedly due to their lack of Current Good Manufacturing Practice (CGMP), including lack of appropriate microbial testing, formulation issues, and lack of measures pertaining to tamper-evident packaging.
A probe into the matter by the Union Ministry’s Central Drugs Standard Control Organisation (CDSCO) as well as Tamil Nadu’s State Drug Controller is reportedly underway.