Two teams from the central and state drug regulatory bodies will inspect Global Pharma Healthcare's manufacturing plant near Chennai after the company recalled its eye drop linked to vision loss in the US, official sources said on Friday.
They said the eye drop is not sold in India.
"Teams from CDSCO (Central Drugs Standard Control Organisation) and State Drug Controller (three persons each) are on their way to the plant located about 40 km south of Chennai. It is a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India," PTI reported.
The US Food and Drug Administration (FDA) has warned against using the eye drop made in India that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients in the United States including infections, blindness and one death.
The agency said on Thursday that Artificial Tears lubricant eye drops manufactured by India's Global Pharma Healthcare Pvt Ltd has a potential bacterial contamination and the company has violated current good manufacturing practices.
Artificial Tears lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.
To date, there are 55 reports of adverse events including eye infections, permanent loss of vision and a death with a bloodstream infection, it added.
Global Pharma Healthcare, based in Chennai, said on Wednesday it is recalling all lots of Artificial Tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination.
EzriCare said in a statement on Wednesday that it had stopped further distribution and sale of the eye drop, and it was not aware of any testing that "definitively links" the bacterial outbreak to the product. A Delsam Pharma spokesperson said the company has removed the products as requested,, adding that the products had a safety seal top and were not associated with customer cases.
In a statement posted on its website, Global Pharma said consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products, it said.
The FDA said it was 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 bacteria.
Two weeks ago, the CDC warned medical professional societies about the possible connection between the drops and the infections.
Infections were diagnosed in patients in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin. One patient in Washington died with a blood infection. At least three others suffered permanent vision loss. They were in California and New Jersey.
The outbreak is considered particularly worrisome because the bacteria driving it are resistant to standard antibiotics.
Investigators found the bacteria were not susceptible to any antibiotics routinely tested at public health laboratories.
How could eye drops cause infections in the blood or lungs? The eye connects to the nasal cavity through the tear ducts. Bacteria can move from the nasal cavity into the lungs. Also, bacteria in these parts of the body can seed infections at other sites such as in the blood or wounds, CDC officials said.
