FDA restrict imports of India-made pharma company linked to vision loss in US

The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination.
For representational purposes
For representational purposes

NEW DELHI: The US Food and Drug Administration (FDA) has restricted imports of products by Chennai-based Global Pharma Healthcare Private Limited after its eye drops were linked to an outbreak of “extensively drug-resistant” bacteria across 12 states in the US, which reportedly infected 55 people and led to the death of one person.

Global Pharma Healthcare is recalling entire lots of eye drops linked to vision loss in the US, according to the US Food and Drug Administration. These eye drops are not sold in India.

The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement.

"The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-ß-lactamase (VIM)- and Guiana-Extended Spectrum-ß-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.

To date, there are 55 reports of adverse events including eye infections, permanent loss of vision and death with a bloodstream infection, it added.

The USFDA noted that the "use of contaminated artificial tears can result in the risk of eye infections that could result in blindness". Artificial Tears Lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.

In a statement released on Thursday, the FDA cited multiple violations of manufacturing regulations by the company, including a lack of appropriate microbial testing and a lack of proper controls concerning tamper-evident packaging.

"FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death," it said.  

FDA’s warning came a day after the US Centers for Disease Control and Prevention issued a health alert to doctors around the country over an unprecedented outbreak of Pseudomonas aeruginosa that had infected at least 55 people across a dozen states.

 FDA also placed import alert on the company for providing an inadequate response to a records request and for not complying with current good manufacturing practice (CGMP) requirements. This would mean the products cannot enter the US.

The specific strain behind the outbreak is said to have never ever been seen before in the US.

While one person died, at least five of the 11 patients who have had infections directly in their eyes have lost their vision, the CDC said.

"Patients who have used EzriCare preservative-free artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately," FDA said.

According to media reports, at one point last year, EzriCare's eye drops had ranked among one of the top ten selling products on Amazon for "dry eye relief."   However, by January, the FDA had added Global Pharma on its "red list" of banned imports. 

The FDA faulted the company for making and selling its eye drops in multiple-use bottles without preservatives, which can make it easier for bacteria to grow between uses.

In a statement posted on its website, Global Pharma Healthcare said it is notifying the distributors of this product Aru Pharma Inc and Delsam Pharma, and is requesting that wholesalers, retailers and customers who have the recalled product should stop using it.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products, it said.

Global Pharma Healthcare produces and supplies a wide range of pharmaceutical formulations in several therapeutic forms to a variety of markets in Southeast Asia, Central America, LATAM, CIS, and Africa.

The eye drop produced by the Chennai-based firm is the latest product from the country to come under scrutiny after some cough syrups were linked to children's deaths in Gambia and Uzbekistan.

This is the third incident of India-made drugs being linked with reported deaths abroad since last October. Earlier, the World Health Organisation (WHO) had issued medical alerts twice for India-made drugs linked to alleged deaths of 66 children in The Gambia and 18 children in Uzbekistan.

(With inputs from PTI)

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