The pharma company had voluntarily recalled its eye drops from the US market.
Chennai:
After a Chennai-based pharmaceutical company was flagged by the US authorities for fatal contamination in a line of eye drops, members of the Tamil Nadu Drug Controller and the Central Drug Control Authority inspected Global Pharma Healthcare Pvt Ltd late last night. The pharma company, based about 40 km south of Chennai, had voluntarily recalled its artificial tear lubricant eye drops from the US market after the country’s health protection agency said they could be contaminated with drug-resistant bacteria that could infect 55 associated with adverse events. including permanent vision loss and one death from bloodstream infection.
Tamil Drug Controller Dr. P.V. Vijayalakshmi said, “We have collected samples from the batches sent to the US, besides taking samples of the raw material used. We are waiting for unopened samples from the US. I have filed a preliminary report to the government.” given.” Nadu told NDTV.
The investigation ended at 2 a.m., and authorities have ordered the manufacturer to suspend production of the ophthalmic solution. Confirming that the plant has a valid license to manufacture and export the product, Dr. Vijayalakshmi said that their investigation will proceed after they receive the test reports of the loose samples from the US, which are still awaited. “They have only tested samples opened from hospitals,” she said.
Global Pharma Healthcare, the drug maker at the center of the controversy, has said it is working closely with the US Food and Drug Administration (FDA). It has advised consumers in the US to stop using the product, and those experiencing adverse effects to seek immediate medical attention, the statement said.
The US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of Azricare Artificial Tears eye drops manufactured by Global Pharma Healthcare, while the FDA said it has moved to restrict imports of products made by the company .
Earlier, Global Pharma Healthcare issued a statement saying that the company was “voluntarily recalling all lots within the expiration date of Artificial Tears Lubricant Eye Drops distributed at the consumer level by Ezricare, LLC – and Delsum Pharma – due to potential contamination.” calling back.”
CBS News reported that doctors across the country have been alerted to an unprecedented outbreak of Pseudomonas aeruginosa, which has affected at least 55 people in a dozen states and caused at least one death.
So far, at least five out of 11 patients who have had direct eye infections have lost their vision, a CDC spokesperson was quoted as saying by the network.
Insider.com reports that Pseudomonas aeruginosa can cause infections in the blood, lungs or wounds, and the germ is proving difficult to treat in recent times due to antibiotic resistance.
An India-made brand of eye drops is the country’s latest pharmaceutical product to come under scrutiny following the deaths of dozens of children linked to cough syrup in Gambia and Uzbekistan last year.