Published: 04th February 2023
#WhatTheFAQ: India-made eye drops leading to vision loss, infection in US? Is this the first of such mishaps?
The US Food and Drug Administration (FDA) has warned against using an eye drop made in India. What is the problem?
The US regulator Food and Drug Administration (FDA) warned consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination". A report by Reuters stated that the Artificial Tears eye drop manufactured by India's Global Pharma Healthcare has a potential bacterial contamination and the company has violated current good manufacturing practices.
This comes after the deaths of at least 70 children in Gambia and 19 children in Uzbekistan last year, allegedly due to India-made cough syrup.
How many have been affected? What is the action being taken? Today's FAQ will answer these questions.
When did the outbreak happen?
The report by Reuters stated that as of January 31, the Centers for Disease Control and Prevention (CDC) had identified 55 patients in 12 states in the United States with infections linked to the use of Artificial Tears distributed by EzriCar. "Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections," the FDA said, as per the Reuters report.
Have the eye drops been removed from the market now?
EzriCare said in a statement on Wednesday, February 2, 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, as stated in the Reuters report.
Moreover, a report by NDTV stated that an investigation was conducted at the Chennai-based pharmaceutical company by Tamil Nadu's Drug Controller and members of the Central Drug Control Authority. The report further added that authorities have ordered the suspension of the production of ophthalmic solutions by the manufacturer.
Is this the first time a pharmaceutical product from India has come under the scanner?
The World Health Organization (WHO) had in October flagged four "contaminated" and "substandard" cough syrups made by an Indian company while warning that they could be linked to the deaths of 66 children in the West African nation of Gambia. The medicines made by New Delhi-based Maiden Pharmaceuticals, which have been largely utilised for paediatric purposes, are believed to contain chemicals that are toxic and potentially fatal, the WHO said, as per PTI.
Several such cases have been reported in India itself. In Jammu and Kashmir, 17 children died in 2020 after consuming a different brand of contaminated cough syrup, however, with the same diethylene glycol. Similarly, 14 children died in Himachal Pradesh this year due to the same contaminants — diethylene glycol.
Remember the Ranbaxy case?
Top Indian drug maker Ranbaxy Laboratories was ordered to pay a record $500m fine in the US in 2013 for improper manufacturing, storing and testing of drugs, according to reports. A report by BBC also stated that they admitted to lying about how it tested drugs at two Indian factories. This is not the first time that concerns over the quality of drugs made and sold in India are being raised. In fact, official government records reveal that between 2007 and 2020, more than 7,500 drugs sampled in just three of India's 28 states and three union territories had failed quality tests, as per the BBC report.