Late-Night Inspection At global Pharma Healthcare, linked to US vision loss case
Tamil Nadu’s Drug Controller and members from the Central Drug Control Authority conducted a late-night inspection of Global Pharma Healthcare Private Limited, which was flagged by US authorities for fatal contamination in a line of eye drops.
The Chennai-based pharmaceutical company had voluntarily recalled its artificial tears lubricant eye drops from the US market after the country’s health protection agency said they could be contaminated with drug-resistant bacteria that have been linked to 55 adverse events, including permanent vision loss and one death from a bloodstream infection.
The investigation concluded at 2 am, and authorities have ordered a suspension of the production of ophthalmic solutions by the manufacturer. Confirming the plant has a valid licence for the manufacture and export of the product, Dr Vijayalakshmi added that their investigation would proceed after they receive investigation reports from the US of the unopened samples, which are still awaited.
Global Pharma Healthcare, the drug manufacturer at the centre of the controversy, has said it’s working closely with the US Food and Drug Administration (FDA). It has also advised consumers in the US to stop using the product, and asked those experiencing adverse effects to seek medical help immediately, besides reporting on a portal it has set up or on its telephone helplines, the statement said.
