No contamination: Tamil Nadu drug regulator on eye drops recalled by US FDA

New Delhi, April 4

The Tamil Nadu drug regulator on Tuesday said there was no contamination in the samples of Global Pharma manufactured eye drops that the US FDA had red-flagged earlier citing blindness in some cases.

The state drug controller office said samples from several batches, including the one under question, were analysed. “We found no contamination. The raw materials used were also as per standards,” PV Vijayalakshmi of the TN Drug Controller office said.

The production of all ophthalmological preparations at Tamil Nadu-based Global Health Care was halted on February 4 after the US flagged one death and 55 adverse events, including loss of vision, due to use of artificial tear drops manufactured at the facility.

The CDC of the US said earlier that artificial tears manufactured and supplied by Global Healthcare Private Limited, Alathur, Kancheepuram, Tamil Nadu, and supplied to Aru Pharma INC, Locus Street, New York, had led to adverse events.