India’s Drug Regulatory body probes contaminated eye drops after US FDA flagged 55 adverse events cases
2 min read . Updated: 04 Feb 2023, 05:38 AM IST
Premium- Using contaminated artificial tears increases risk of eye infections that could result in blindness or death, US FDA said
Hours after Indian pharmaceutical company--Global Pharma Healthcare issued voluntary nationwide recall of its “artificial tears" --lubricant eye drops due to “possible contamination"; the union health ministry’s Central Drugs Standard Control Organization (CDSCO) and State Drug Controller have sent their team to plant located about 40 km south of Chennai, person aware of the matter said.
Doctors say that use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.
“It is learnt that teams from CDSCO and State Drug Controller comprising of three persons each are on their way to the plant located about 40 km south of Chennai. It is a contract manufacturing plant supplying through others to US market. This specific drug is not sold in India," the person said.
This comes in the backdrop after US FDA on 2 February warned 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. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile," said US FDA statement.
FDA recommended this recall of eye drops due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
US Centre for Disease Control (CDC) identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. “Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA," it said.
“Global Pharma Healthcare 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. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-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," stated the company press statement.
So far, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection, it said.
Queries sent to the health ministry did not elicit any response.
