Regulators suspend prodn of Global Pharma Healthcare's ophthalmic range of products: Reports
Chennai-based Global Pharma Healthcare has been asked to stop the production of its ophthalmic range of products after a joint inspection of Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller of its production site on Friday, media reports said.
The pharma company has been under the scanner of the US FDA for potential bacterial contamination of its eye drops, reports said.
According to media reports, the firm was directed to stop manufacturing all products under the category of ophthalmic preparation until the completion of the investigation.
The US FDA has placed Global Pharma Healthcare Private Limited on import alert, preventing the entry of these products from entering the United States, Business Standard reported.
Global Pharma Health’s manufacturing plant is in Thiruporur, Kancheepuram, around 40 km from Chennai.
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 report said.
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, according to the report.
Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections.
The US Food and Drug Administration has said in a statement that 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, Economic Times reported.
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.