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NEW DELHI: Manufacturing of all ophthalmic preparations have been stopped at the Chennai unit of Global Healthcare Pvt Ltd, the pharmaceutical firm which is under investigation for alleged contamination of ‘artificial tears’ exported by it to the US.
Allegedly, EzriCare, a brand of artificial tears (eye drop) exported by the company to the US, was contaminated with drug-resistant bacteria which led to at least 55 cases of infection in 12 states in the US and one death. EzriCare is not sold in India.
According to health ministry sources, following reports of bacterial infection in the US, a joint inspection of the manufacturing plant was carried out on Friday by officials of the Central Drugs Standard Control Organisation (CDSCO) and the Tamil Nadu Drugs Control Department.
“During the inspection, it was found that the firm, Global Health Care Pvt Ltd, exported two consignments of 24 batches of artificial tears to USA which were manufactured in the year 2021 and 2022. Though the firm didn’t have stocks of the above batches, it had maintained their control samples. The inspection team took some of these samples and samples of raw material utilised for manufacturing the product in question for analysis,” said a source.
The manufacturing records of all batches, purchase invoices of raw materials, sales bills copies, media fill validation reports were also obtained for further investigation, the source added.
“The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of investigations,” a senior CDSCO official said.
The US FDA (US Food and Drug Administration) recently issued a warning consumers and healthcare practitioners in the country directing that they should not purchase and immediately stop using EzriCare Artificial Tears due to potential bacterial contamination. “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,” it warned.
The US FDA also issued its orders for recall of the particular product from the market after it found that the company to have violated certain Current Good Manufacturing Practice (CGMP), 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 Aeruginosa bacteria,” the US FDA said. In its statement issued on Thursday, the drug regulator said that as of January 31, 55 patients in 12 US states had been identified with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. “Associated adverse events include hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections,” it added.
The US controversy comes months after reports of alleged contamination in cough syrups imported by two Indian Pharmaceutical companies emerged from Gambia and Uzbekistan respectively.
Allegedly, EzriCare, a brand of artificial tears (eye drop) exported by the company to the US, was contaminated with drug-resistant bacteria which led to at least 55 cases of infection in 12 states in the US and one death. EzriCare is not sold in India.
According to health ministry sources, following reports of bacterial infection in the US, a joint inspection of the manufacturing plant was carried out on Friday by officials of the Central Drugs Standard Control Organisation (CDSCO) and the Tamil Nadu Drugs Control Department.
“During the inspection, it was found that the firm, Global Health Care Pvt Ltd, exported two consignments of 24 batches of artificial tears to USA which were manufactured in the year 2021 and 2022. Though the firm didn’t have stocks of the above batches, it had maintained their control samples. The inspection team took some of these samples and samples of raw material utilised for manufacturing the product in question for analysis,” said a source.
The manufacturing records of all batches, purchase invoices of raw materials, sales bills copies, media fill validation reports were also obtained for further investigation, the source added.
“The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of investigations,” a senior CDSCO official said.
The US FDA (US Food and Drug Administration) recently issued a warning consumers and healthcare practitioners in the country directing that they should not purchase and immediately stop using EzriCare Artificial Tears due to potential bacterial contamination. “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,” it warned.
The US FDA also issued its orders for recall of the particular product from the market after it found that the company to have violated certain Current Good Manufacturing Practice (CGMP), 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 Aeruginosa bacteria,” the US FDA said. In its statement issued on Thursday, the drug regulator said that as of January 31, 55 patients in 12 US states had been identified with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. “Associated adverse events include hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections,” it added.
The US controversy comes months after reports of alleged contamination in cough syrups imported by two Indian Pharmaceutical companies emerged from Gambia and Uzbekistan respectively.
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