New Delhi: The US Food and Drug Administration (FDA) has restricted the imports of products manufactured by Chennai-based Global Pharma Private Healthcare Limited, after the company’s eye drops were linked to an outbreak of drug-resistant bacteria across the US, which reportedly infected 55 and led to the death of one person.
Global Pharma Healthcare Private Limited’s artificial tears — sold under the brand names EzriCare or Delsam Pharma — were recalled by the firm on 1 February, after the FDA received an alert from the US Centers for Disease Control and Prevention (CDC) about possible contamination.
This is the third incident in the past few months of Indian pharmaceutical products being linked to deaths in other countries.
Last month, 20 children in Uzbekistan died, reportedly after consuming cough syrup marketed by Noida-based Marion Biotech. Before that in October last year, 66 deaths in Gambia were linked to the consumption of cough syrups from the Indian company Maiden Pharmaceuticals.
In a statement, Global Pharma said that clusters of Verona Integron-mediated Metallo-β-lactamase (VIM)-and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections, detected in multiple US states, were possibly associated with the use of the artificial tears.
According to the statement, this bacteria is resistant to carbapenem antibiotics, which are typically used to treat severe infections.
“Global Pharma is fully cooperating with US Federal authorities, and is continuing to investigate this matter, but thus far we have not determined whether our manufacturing facility is the source of the contamination,” a company spokesperson told ThePrint in an email. “Nevertheless, out of an abundance of caution, we are recalling the products at issue. Our internal investigation is on,” the spokesperson added.
The spokesperson also said that the product is “contract manufactured for one customer in USA” and is not sold in India.
Also read: CBI chargesheet in Biocon case raises questions about how India manages drug trials
‘Lack of appropriate microbial testing’
On Thursday, the US FDA published a statement warning consumers and healthcare practitioners not to purchase, and immediately stop using, EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears owing to potential bacterial contamination.
The FDA cited multiple violations of manufacturing regulations by the company, including a “lack of appropriate microbial testing” and a “lack of proper controls concerning tamper-evident packaging”.
“Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the agency said in its statement.
According to the FDA, the company manufactures and distributes the eye drugs in multi-use bottles, without an adequate preservative. Ideally, such eyedrops should be sterile to prevent the growth of pathogens, it said.
The VIM-GES-CRPA strain is rare in the US, the FDA said in its statement. However, by 31 January this year, the CDC had 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 hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections.
The CDC reported that testing of opened bottles of EzriCare eye drops from patients in two different states turned up bacteria matching the outbreak strain.
“VIM-GES-CRPA recovered from opened bottles could represent either bacterial contamination during use or during the manufacturing process. Testing of unopened bottles of EzriCare Artificial Tears is ongoing,” the CDC said.
The strain is extensively drug-resistant, because several antibiotics tested by the CDC are unable to fight the bacteria. Only one — cefiderocol — appears to work for the strain.
“Patients who have used EzriCare preservative-free artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately,” the CDC said in its statement.
(Edited by Poulomi Banerjee)
Also read: Here’s why Nepal banned 16 Indian pharma companies, including Patanjali’s Divya Pharmaceuticals