According to Health Ministry sources, “This is a contract manufacturing plant that supplies the US market through others. This exact drug is not available in India.” According to the company announcement, the eye drops are distributed by ErziCare and Delsam Pharma.
Medicines used to treat eye irritation or dryness are sold without a prescription. “The product was distributed domestically in the United States via the Internet,” the company said in a statement.
Pseudomonas aeruginosa Pathogen Identified in Eye Drops
The Centers for Disease Control and Prevention identified a multistate cluster Pseudomonas aeruginosa bacteria resistant to the third-line drug carbapenem.
Advertising
Unlike Gambia and Uzbekistan, where Indian officials halted production after concerns were raised, the Chennai company has withdrawn the product itself. The Indian regulator, on the other hand, followed the same procedure by inspecting the plant shortly after the reports.
The Indian regulator closed the plants after similar inspections found that facilities in Haryana and Uttar Pradesh were not following good manufacturing practices. After that, a risk-based inspection was carried out in the drug manufacturing companies.
18 babies in Uzbekistan died of kidney failure after drinking two Marion Biotech syrups. The deaths of 70 children from acute kidney injury in The Gambia have been linked to four Maiden Pharma syrups. Diethylene glycol and ethylene glycol are claimed to be present in both syrups.
FDA Alert
The FDA has warned consumers and doctors to avoid buying and using the product. According to the warning, “use of contaminated artificial tears increases the risk of eye infections that can lead to blindness or death.”
The recall was recommended by the FDA due to manufacturing violations such as lack of proper microorganism testing, formulation problems (the corporation manufactures and distributes ophthalmic drugs in multi-use containers with insufficient preservatives), and lack of adequate anti-counterfeiting controls. packaging.
Chennai-based Global Pharma Healthcare 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 related to the use of the product. There are no eye drops in India.
The CDC reported 55 adverse events to the FDA, including eye infections, irreversible vision loss, and one death due to a bloodstream infection. The CDC looked at a multi-state outbreak of drug-resistant disease linked to the use of ‘Artificial Tears’, lubricating eye drops in the US, supplied by EzriCare, LLC and Delsam Pharma.
The FDA issued a warning on Friday, telling consumers and doctors not to buy or stop using the product. According to the warning, “use of contaminated artificial tears increases the risk of eye infections that can lead to blindness or death.”
The recall was recommended by the FDA due to manufacturing violations such as lack of proper microbial testing, formulation problems (the company manufactures and distributes the ophthalmic drug in reusable bottles with insufficient preservatives) and lack of proper anti-counterfeiting controls. packaging.
While investigating an outbreak of an unusual, drug-resistant strain Pseudomonas aeruginosa, US agencies have been notified. The corporation has been placed on the United States Food and Drug Administration’s import alert list due to an inadequate response to a record request. This warning is intended to prevent the use of the company’s products.
Murali Neelkantan, a former global Cipla consultant, pointed out that the problem with eye drops or IV fluids is that they enter the body and must be manufactured, packaged and distributed in an extremely clean environment. “In another example involving a corporation shipping eye drops to the UK, investigators found contamination in shipping containers containing sealed and packaged eye drops. Although there was no indication that the eye drops were contaminated, the containers were not allowed to enter the market and should have been destroyed.” .
He further noted that quality, especially sterility, must be monitored at every stage – pre-production and throughout the supply chain, where strict temperature records must be kept inside containers, at the port of entry and during distribution. .
Source: Medium
