NEW DELHI (AA): Authorities in the Indian southern state of Tamil Nadu have asked a pharma firm to halt the manufacturing of ophthalmic products after US health officials issued an alert regarding possible contamination of eye drops with adverse events in patients, an official said on Sunday.
This week, the Chennai city-based Global Pharma Healthcare company “voluntarily” recalled artificial tears lubricant eye drops and said it is notifying the US distributors about this product.
“Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC and Delsam Pharma to the consumer level, due to possible contamination,” the firm said in a statement.
On Sunday, Tamil Nadu’s top drug official told Anadolu that instructions have been issued to halt the production and further investigations are underway.
“We have asked the firm to stop the production of all items permitted under the category of ophthalmic preparation until the investigation is completed,” Vijayalakshmi PV, the drug controller of Tamil Nadu, said.
She also said that an inspection was also carried out at the firm and samples were taken.
Officials also said that the drug in question was only exclusively meant for the US and it was not available in India. The inspection was carried out on Friday night.
On Feb. 1, the US Centers for Disease Control and Prevention (CDC) issued an advisory about “infections with an extensively drug-resistant strain … in 12 states.”
“Most patients reported using artificial tears … the majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles,” it said, adding that authorities have identified 55 case-patients in 12 states.
“Patient outcomes include permanent vision loss resulting from cornea infection, hospitalization, and one death due to systemic infection,” the CDC said.
It also added: “Patients and healthcare providers should immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the Food and Drug Administration (FDA).”
Last month, India suspended the license of a pharma firm that manufactured a cough syrup linked to the death of at least 19 children in Uzbekistan.
Earlier, a similar incident took place in Gambia in October last year when World Health Organization issued a medical alert for four contaminated medicines linked with acute kidney injuries and 66 child deaths. The medicines were cough and cold syrups produced by Maiden Pharmaceuticals Limited in India.
However, in December last year, the Indian Parliament was informed by the Health Ministry that “control samples” of the drugs from the manufacturing unit were drawn and sent for test and analysis.
“As per the report of the government analyst, the samples have been declared to be of standard quality,” the ministry had said.
