An Indian pharmaceutical company has been placed under the scanner once again, with the United States (US) reporting possible contamination of a line of eye drops produced by a Chennai-based company. The report linked multiple deaths and infections in the country to the Indian manufactured product, following which the Indian company has recalled their entire lot of eye drops.
The India-made eye drops are the latest product from the country's pharmaceuticals to land under scrutiny after the death of dozens of children in Gambia and Uzbekistan last year was linked to Indian-made cough syrups.
Permanent Vision Loss & Infection
Global Pharma Healthcare, the Chennai-based pharmaceuticals, have recalled their entire lot of eye drops after the US Food and Drug Administration (FDA) linked it to vision loss in the US. The product has been suspended from the US market after the country's health protection agency voiced concerns about possible contamination of the eye drops with a drug-resistant bacteria. This particular bacteria has been responsible for cases of permanent vision loss and one death from a bloodstream infection.
Following this, the US Centers for Disease Control and Prevention (CDC) has begun testing the unopened bottles of EzriCare Artificial Tears eye drops manufactured by Global Pharma Healthcare. The FDA has also warned consumers and medical practitioners not to purchase the product and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears. The agency further added that "using contaminated artificial tears increases the risk of eye infections that could result in blindness or death."
The Artificial Tears Lubricant eye drops were used as protectants against irritation or to relieve the dryness of the eye. To date, they have linked 55 reports of such adverse events, including eye infections, permanent loss of vision, and death from a bloodstream infection.
Health practitioners have also been alerted to the unprecedented outbreak of Pseudomonas aeruginosa, which has affected people across a dozen states and is responsible for at least one death. According to a report by India Today, Pseudomonas aeruginosa causes infections in the blood, lungs, or wounds, and the germ is proving to be tougher to treat with growing antibiotic resistance.
Consumers Advised To Seek Medical Resources
Multiple media reports suggest that at least five of the 11 patients who reported infections directly in their eyes have lost their vision. Responding to the health emergency, Global Pharma Healthcare notified distributors of this product (Aru Pharma Inc and Delsam Pharma) and posted a statement on their website requesting wholesalers, retailers, and customers to stop using the eye drops.
Consumers using the product have been advised to contact their physician or healthcare provider if they experience or have experienced any problems that could be related to using these over-the-counter drug products. Presently, teams from Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller are on their way to the Global Pharma Healthcare plant to probe the concern.
Also Read: Drugs Without Prescriptions: After Gambia, Uzbekistan Links Death Of 18 Kids To Indian-Made Cough Syrup