Indian health authorities have ruled out any bacterial infection in samples of eye drops made by Chennai-based Global Pharma Healthcare, which were flagged by US watchdog Centers for Disease Control and Prevention, (CDC.)
CDC flagged and recalled EzriCare Artificial Tears for the presence of “a rare strain of extensively drug-resistant” bacteria, that caused eight patients to lose vision in one of their eyes and infections in numerous others.
According to a NDTV report quoting sources in the Union Health Ministry, America’s drug regulator is the US Food and Drug Administration (USFDA) and not the CDC. The former institution has not raised any objections about the Artificial Tears product. However, the Drugs Controller General of India has raised the issue and is awaiting their response.
According to the report, an inspection of the product was carried out jointly by Tamil Nadu’s Drug Controller and the Central Drugs Standard Control Organisation in February, which did not flag any inconsistencies.
Speaking to NDTV, Tamil Nadu Drugs Control PV Vijayalakshmi days, "Samples from several batches, including the one under question, were analysed. We found no contamination. The raw materials too were found as per standards."
In light of the accusations, the pharma company has “voluntarily” recalled the eye drop phials which were sent to America, though the Indian drug controllers did not ask it to withdraw the same.
