After cough-syrup, now eye drops: India-made solution causes 1 death, several infections in US

An India-based pharmaceutical company has halted its production of eye drops after the US Centers for Disease Control and Prevention (CDC) said they could be linked to infecting 55 patients and the death of one person across 12 states in the country.

One patient died due to systemic infection, while other outcomes included permanent vision loss resulting from cornea infection and hospitalisation. These incidents occurred between May 2022 and January 2023.

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After the adverse events, CDC issued a health advisory on February 1, 2023, about a drug-resistant strain of pseudomonas aeruginosa in the patients who used the eye drops.

The Food and Drug Administration (FDA) has also recommended recalling the eye drops, citing failure to comply with Good Manufacturing Practices. 

The FDA said in a statement:

FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death.

Pseudomonas aeruginosa is a pathogen found in the environment, typically causing infections in hospital settings and has not yet been recorded as a common bacterial infection from eye drops. It is resistant to a host of antibiotics — at least 12 — and responds only to cefiderocol, a complex antibiotic usually used as a last resort, according to the CDC.

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The medicine was being distributed by EzriCare, a US-based firm, which was sourcing the eye drops from Global Pharma Healthcare. This Tamil Nadu-based manufacturer has now stopped the production of all 14 ophthalmic solutions and initiated the recall process of the product under investigation.

The incident could be particularly damning for India’s drug regulatory system since it is coming on the heels of cough-syrup-associated deaths in The Gambia and Uzbekistan, both of which sourced the drugs from here.

“(The pathogen) recovered from (the) opened bottles could represent either bacterial contamination during use or during the manufacturing process,” the CDC said in its alert. 

Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing, CDC added.

Samples of the product are currently being tested by a government lab in Tamil Nadu to assess if there was any lapse in the manufacturing process.

“We have collected many control samples of the same batches which were sent to the US. The samples of raw materials used in making those batches have also been collected for investigation,” Tamil Nadu drugs controller PV Vijayalakshmi was quoted as saying to The Wire. 

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How a pathogen like Pseudomonas aeruginosa made its way into eye drops remains a mystery. Had it been a handful of cases, it would have been possible that they acquired the infection from their environment. But more than 50 patients hint at lapses in either manufacturing and transporting.

“If the environment was not infection-free during manufacturing, then the Pseudomonas might have crept from there also,” an antimicrobial expert from the Indian Council of Medical Research (ICMR) told The Wire.

Even during packaging and transportation of eye drops, this bacterial invasion may occur even due to a small slip, the expert added.

The CDC recommends a host of steps to be taken by healthcare providers, clinical laboratories and the public. These include avoiding the consumption of EzriCare Artificial Tears until the treatment is declared safe.

Read more:

• Antimicrobial resistance: India needs waste management, process control to prevent antibiotic pollution
• Charity after profiteering, the Big Pharma way
• WHO alert on ‘sub-standard’ cough syrups made by Noida firm

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