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Chennai-based Global Pharma Healthcare, which has been under the scanner of the US FDA for potential bacterial contamination of its eye-drops, has been asked to stop production of its ophthalmic range of products at its site.
A joint team of officials from the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller inspected the site on Friday.
In the joint investigation report (Business Standard has a copy of the report) the drug inspector CDSCO South Zone C Manivillavan and Deepa Joseph, senior drugs inspector, Kancheepuram zone, Director of Drugs Control, Tamil Nadu have noted that the manufacturer was instructed 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 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 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.
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.
Global Pharma Health operates its plant in Thiruporur, Kancheepuram, around 40 kms from Chennai. During the joint inspection it was found that Global Pharma Health had exported two consignments of 24 batches that were manufactured in 2021 and 2022.
During the investigation no stocks of these batches were found. The firm had maintained control samples of the batches under review, and samples were collected by the Indian regulators to test. The raw material carboxy methyl cellulose sodium samples were also taken.
Global Pharma Health has not done root cause analysis of the complaint from the US FDA, the inspection report said. The company has done stability studies of the batches under question once a year. The officials have collected the invoices, sales bill copies, manufacturing records etc from the company.
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.
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