- Sunday, March 02, 2025
By: Shubham Ghosh
In a development that could serve yet another blow to India’s image of ‘world’s pharmacy’, the Indian manufacturer of eye drops that were linked to three deaths and serious infections in the US, violated a number of safety norms, the North American country’s top regulator has said, according to the BBC.
However, the drug controller of the southern Indian state of Tamil Nadu where the accused manufacturer Global Pharma is located, said it found “no contamination” in samples of eye drops made by it, India’s NDTV reported.
The US Food and Drug Administration (FDA) came up with a report last week after inspecting the Indian drug company’s plant in Chennai, capital of Tamil Nadu. The firm recalled the drops in February following a recommendation from the FDA.
The FDA had also halted imports of the products.
The eye drops — manufactured in India by Global Pharma and imported to the US under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, were linked to a serious outbreak of drug-resistant infections in America.
Last month, the US Centers for Disease Control and Prevention identified 68 patients in 16 states of the country with a rare strain of Pseudomonas aeruginosa, which can cause serious infections, especially among those who are immunocompromised. The drug-resistant strain had never been found in the US before the latest outbreak, the report added.
Besides the deaths, eight people suffered loss of vision while four had their eye removed surgically, a BBC report said in March.
EzriCare Artificial Tears said it marketed the eye drops and had no role in the product’s “actual manufacturing”.
The FDA carried out an 11-day inspection of the Global Pharma plant in Chennai from February 20, and said in its report that it found many violations related to sterilisation and hygiene.
The FDA report said that surfaces that came into contact with the drug packaging “were not cleaned, sanitised, decontaminated, or sterilised”, the BBC report added.
The CDC was even concerned that the bacteria could gain a foothold in the US healthcare system, The New York Times reported on Monday (3).
“I think we are going to see the impact of this play out over the course of months to years,” Maroya Walters, lead investigator for the CDC’s antimicrobial resistance team, was quoted as saying by the newspaper.
However, director of the Tamil Nadu Drugs Control PV Vijayalakshmi said no contamination was found in samples from unopened eye drops manufactured by the plant in Chennai, the NDTV report added.
“Samples from several batches, including the one under question, were analysed. We found no contamination. The raw materials too were found as per standards,” the drug regulator’s director was quoted as saying.
She refused to comment on the US watchdog’s observations on the eyedrops.
In recent months, a number of Indian firms have come under scrutiny for the quality of their drugs and recently, Indian authorities cancelled licences of 18 firms for spurious drugs in a massive drive.
