Late-Night Inspection At Chennai Firm Linked To Vision Loss, Death In US

Chennai:

Acting swiftly after a Chennai-based pharmaceutical company was flagged by US authorities for fatal contamination in a line of eye drops, Tamil Nadu’s Drug Controller and members from the Central Drug Control Authority conducted a late night inspection of Global Pharma Healthcare Private Limited. The pharma company, located about 40 km south of Chennai, 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.

“We have collected samples from the batches sent to the US, besides samples of raw materials used. We are awaiting unopened samples from the US. I’ve filed a preliminary report to the government,” Dr P V Vijayalakshmi, the Drug Controller of Tamil Nadu, told NDTV.

The investigation concluded at 2 am, and authorities have ordered suspension of production of ophthalmic solutions by the manufacturer. Confirming the plant has valid licence for 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. “They have only examined the opened samples from hospitals,” she said.

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.

The US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare, while FDA said it has moved to restrict imports of products made by the company.

Earlier, Global Pharma Healthcare had issued a statement, saying the company “is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC – and Delsam Pharma, to the consumer level, due to possible contamination”.

Doctors around the country have been alerted to an unprecedented outbreak of Pseudomonas aeruginosa, affecting at least 55 people across a dozen states, and at least one death, CBS News reported.

So far, at least five of the 11 patients who have had infections directly in their eyes have lost their vision, a CDC spokesperson was quoted as saying by the network.

Pseudomonas aeruginosa can cause infections in the blood, lungs, or wounds and the germ has been proving tougher to treat in recent times because of antibiotic resistance, Insider.com reported.

The India-made brand of eye drops are the latest pharmaceutical product from the country to land under scrutiny after dozens of deaths among children in the Gambia and Uzbekistan last year linked to cough syrups.