Chennai-based firm’s eye drops contaminated, says US FDA report

Chennai-based pharmaceutical company Global Pharma Healthcare has suspended production of a line of eye drops that it sold in the US market after that country’s regulator warned consumers to stop using these eye-drops due to potential bacterial contamination.

According to sources in the Union Health Ministry, teams from the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller (three officials each from the Centre and State) are on their way to the Global Pharma Healthcare plant located about 40 km south of Chennai.

These products are not sold in India, the source added.

FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert prevents these products from entering the United States.

The US FDA said that 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.

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 the FDA has moved to restrict imports of products made by the company.

“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,” the FDA said in a statement.

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall 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.

As of January 31, 2023, 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.