Govt body suspends manufacturing of India's eye drops linked to blindness in US
1 min read . Updated: 04 Feb 2023, 02:08 PM IST
Premium- US FDA has warned consumers ‘not to purchase or use EzriCare Artificial Tears’ due to potential contamination
India's Central Drugs Standard Control Organisation (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after US FDA allegedly linked 55 adverse events cases with contaminated eye drops.
The US-based Food and Drug Administration has warned consumers “not to purchase or use EzriCare Artificial Tears" due to potential contamination. The eye drops are manufactured by Chennai-based Global Pharma Private Healthcare Limited.
FDA has restricted the import of eye drops and asked all health practitioners in the country to stop the sale of the "contaminated" eye drops.
Using contaminated artificial eye drops increases the risk of eye infections that could result in blindness or death.
The FDA recommended to recall of the 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.
Meanwhile, 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.
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 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 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.
