After Cough Syrups, Indian-Based Eye Drops Face a Ban

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Highlights:

• Consumers in the United States have been warned not to use the EzriCare brand of artificial tears manufactured by a Chennai-based company
• The US regulatory action comes only days after the CDC issued a notice following the identification of 55 cases of illness in 12 states
• It was after a study discovered a possible relationship between eye drops and drug-resistant bacteria, resulting in eye infections, vision loss, and death

Following two incidents in which India-made syrups were linked to the deaths of children in the Gambia and Uzbekistan, a Tamil Nadu-based company has voluntarily recalled an eye drop from the United States after it was linked to a drug-resistant infection. The eye drop has been associated with 55 cases of infections, vision loss, and even death as a result of the infection entering the circulation.

A joint team of six central and state drug inspectors hurried to the company's plant, located 40 kilometers south of Chennai, a day after the US Food and Drug Administration released an alert advising people to stop selling and using the eye drop.

‘'Artificial tears' created in India have been connected to a superbug outbreak in the United States. Imports are restricted by the FDA.’

"It is a contract manufacturing plant that supplies the US market through others. This precise medicine is not available in India," according to Health Ministry sources. The eye drop was distributed by ErziCare and Delsam Pharma, according to the company's announcement.

The medication, which is used to treat eye irritation or dryness, is available without a prescription. "The product was distributed nationwide in the United States via the internet," according to the company's statement.

Pseudomonas aeruginosa Pathogen Identified in Eye Drops

The Centers for Disease Control and Prevention identified a multi-state cluster of Pseudomonas aeruginosa bacteria that were resistant to the third-line drug carbapenem.

Unlike in the Gambia and Uzbekistan, where Indian officials halted production after concerns were raised, the Chennai company withdrew the product itself. The Indian regulator, on the other hand, followed the same procedure, with an inspection of the plant conducted shortly after the reports.

The Indian regulator shut down the plants after similar checks revealed that the enterprises in Haryana and Uttar Pradesh were not following good manufacturing methods. Following that, a risk-based inspection of medication manufacturing companies was conducted.

In Uzbekistan, 18 toddlers allegedly died of kidney failure after drinking two Marion Biotech syrups. In the Gambia, the deaths of 70 children from acute kidney injury were connected to four Maiden Pharma syrups. The impurities-diethylene glycol and ethylene glycol-were allegedly present in both syrups.

FDA Warning

The FDA issued a warning to consumers and doctors to avoid purchasing and using the product. "Using tainted artificial tears raises the risk of eye infections, which can end in blindness or death," according to the warning.

The recall was recommended by the FDA due to manufacturing violations such as a lack of appropriate microorganism testing, formulation issues (the corporation manufactures and distributes ophthalmic drugs in multi-use containers with insufficient preservatives), and a lack of proper controls regarding tamper-evident packaging.

Global Pharma Healthcare, based in Chennai, has recalled its eye drops from the US market after the Centers for Disease Control and Prevention reported that numerous patients had experienced adverse events that were likely related to the use of the product. In India, eye drops are not available.

The CDC had notified the FDA that there had been 55 occurrences of adverse events, including eye infections, irreversible vision loss, and one death due to a bloodstream infection. The CDC was looking into a multi-state outbreak of drug-resistant illness cases that were related to the usage of 'Artificial Tears,' lubricating eye drops supplied in the United States by EzriCare, LLC, and Delsam Pharma.

The FDA issued a warning on Friday, instructing consumers and doctors not to purchase and discontinue the use of the product. "Using tainted artificial tears raises the risk of eye infections, which can end in blindness or death," according to the warning.

The recall was recommended by the FDA due to manufacturing violations such as a lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles with insufficient preservatives), and a lack of proper controls regarding tamper-evident packaging.

While examining an outbreak of an unusual, drug-resistant strain of Pseudomonas aeruginosa, the US agencies were notified. The corporation has been placed on the United States Food and Drug Administration's import alert list for an inadequate response to a records request. This warning is intended to prevent the company's products from being used.

Murali Neelkantan, former Cipla worldwide counsel, stated that the problem with eye drops or IV fluids is that they are administered within the body and must be manufactured, packed, and distributed in extremely clean surroundings. "In another example involving a corporation whose eye drops were to be shipped to the United Kingdom, investigators discovered contamination in shipping containers containing the sealed and packaged eye drops. Even though there was no indication that the eye drops were tainted, the containers were not allowed to access the market and had to be destroyed."

He went on to say that quality, particularly sterility, needs to be monitored at every stage-before and throughout manufacturing, throughout the supply chain, where stringent temperature logs should be kept inside the containers, at the port of entry, and while being dispensed.



Source: Medindia

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