CDSCO suspends manufacturing of eye drops linked to 55 adverse events in US
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 requirement.
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has suspended the manufacturing of eye drops and initiated its probe after the United States' Food and Drug Administration (FDA) allegedly linked 55 adverse events cases with contaminated eye drops, sources said on Saturday adding that the investigating agencies in both the countries are constantly investigating the matter.
According to the people aware of the matter, the US-based Food and Drug Administration has warned the consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination", and the Union Health Ministry's CDSCO and Tamil Nadu's State Drug Controller have initiated a probe into the matter.
"Teams from CDSCO and TN State Drug Controller (three persons each) are on their way to the manufacturing plant located near Chennai. It's a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India," it said.
FDA has also restricted the imports of products manufactured by Chennai-based Global Pharma Private Healthcare Limited.
"The import alert prevents these products from entering the United States," said FDA in a statement adding "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."
These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be "sterile".
Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.
The FDA further said that it 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.
The FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas bacteria.
The US Centre for Disease Control (CDC) identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to the use of EzriCare Artificial Tears.
"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," it claimed further.
The associated adverse events include hospitalization, one death from bloodstream infection, and permanent vision loss from eye infections. The CDC has issued an alert recommending consumers to stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
Meanwhile, the 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.
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