Drug Regulatory body takes samples of Eye drops from Chennai-based pharma company after US FDA flags contamination
Feb 04, 2023
New Delhi [India], February 4 : After a Chennai-based pharmaceutical company was flagged by US authorities over lethal contamination in the eye drops, members of Tamil Nadu's Drug Controller and Central Drug Control Authority conducted a late-night inspection of manufacturing premises of Global Pharma Healthcare Private Limited, sources said.
During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to the USA which were manufactured in 2021 and 2022, added the sources.
"The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken," added the sources.
Central Drugs Standard Control Organization (CDSCO) has barred the manufacturing of EzriCare Artificial Tears at the Chennai-based firm after US FDA alleged adverse events due to the use of eyedrops, said a statement on Saturday.
US regulator Food and Drug Administration warned consumers "not to purchase or use Chennai-based manufacturer EzriCare Artificial Tears due to potential contamination", added the statement.
The CDSCO and Tamil Nadu State Drug Controller have initiated a probe into the matter, a source aware of the issue said on Friday.
The investigation has been started after Centres published the news for Disease Control and Prevention (CDC) USA that the Artificial tears manufactured and supplied by Global Healthcare Private limited have reported adverse events including eye infections permanent loss of vision and death with a bloodstream infection.
The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation.
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," FDA said 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 the risk of eye infections that could result in blindness or death," the statement further read.
