Late-Night Inspection At Chennai Firm Linked To Vision Loss, Death In US
The Central Drug Control Authority and Tamil Nadu’s Drug Controller quickly acted after US officials warned a Chennai-based pharmaceutical company about lethal contamination in a brand of eye drops. They performed a late-night investigation of Global Pharma Healthcare Private Limited.
After the US health protection agency warned that the pharmaceutical company’s artificial tears lubricant eye drops might contain drug-resistant bacteria linked to 55 adverse events, including permanent vision loss and one death from a bloodstream infection, the company voluntarily voluntarily recalled its products from the US market. The company is located about 40 km south of Chennai.
“We have collected samples from the batches sent to the US, besides samples of raw materials used. We are awaiting unopened samples from the US. I’ve filed a preliminary report to the government,” Dr P V Vijayalakshmi, the Drug Controller of Tamil Nadu, told NDTV.Authorities have mandated that the manufacturer stop producing ophthalmic solutions as of 2 am following the conclusion of the investigation. Dr. Vijayalakshmi stated that their probe will move forward once they received investigation reports from the US of the unopened samples, which are still awaited, after confirming the plant has a valid licence for the manufacture and export of the product. She stated that “they have just looked at the opened samples from hospitals.”
The medicine maker at the centre of the dispute, Global Pharma Healthcare, has stated that it is collaborating extensively with the US Food and Drug Administration (FDA). According to the statement, it has also urged US users to avoid taking the medicine and requested anyone having negative side effects to get medical care right once in addition to reporting the issue on a portal it has set up or by calling its phone helplines.
Global Pharma Healthcare’s EzriCare Artificial Tears eye drops are being tested by the US Centers for Disease Control and Prevention (CDC), while the FDA has announced steps to limit imports of the company’s goods.
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