New Delhi: A day after the US Food and Drug Administration (FDA) restricted imports of products manufactured by Chennai-based Global Pharma Private Healthcare Limited over an outbreak of drug-resistant bacteria in the US, a joint team investigation by the Drugs Control, Tamil Nadu, and Central Drugs Standard Control Organisation (CDSCO), South Zone, has instructed the company to stop all manufacturing activities immediately.
A team from both the central and state drug authorities visited the manufacturing plant in Tamil Nadu’s Kancheepuram, 40 km from Chennai, Friday after the company recalled the eyedrops that were linked to 55 infections and one death in the US.
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.
The joint investigation found that Global Pharma Healthcare Private Limited exported 2 consignments of 24 batches of this contaminated eyedrop to the US. In contrast, no stocks of the exported batches were found at the factory, the report said.
The team also collected samples of eye drops and the raw material, Carboxy Methyl Cellulose Sodium, used to make the product.
It’s significant to note that this particular brand of eyedrops is not sold in India.
“It is observed that the firm has not carried out the complete root cause analysis in respect of the above complaint and stated that it was under process. On verification of records, it is noticed that the firm has done the stability studies for the representative batch of said drugs yearly once,” the joint investigation report said.
This is the third such incident in the past year where Indian pharmaceutical products have been linked to deaths in other countries, such as Uzbekistan and The Gambia.
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Company’s statement
In a statement Wednesday, 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 drops.
According to the CDC, this strain of bacteria is extensively drug-resistant, including carbapenem antibiotics, typically used to treat severe infections. So far, only one — cefiderocol — appears to work for the strain.
By 31 January, the CDC had identified 55 patients in 12 states with infections linked to the use of EzriCare Artificial Tears, resulting in hospitalisation, one death due to bloodstream infection, and permanent vision loss.
The CDC in its statement has instructed any patients who have signs or symptoms of an eye infection, after using EzriCare preservative-free artificial tears, to seek medical care immediately.
(Edited by Uttara Ramaswamy)
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