Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by Chennai-based Global Pharma, which has hit headlines after a US watchdog linked cases of infections, blindness and even deaths to the eye drops.
The director of the Tamil Nadu Drugs Control PV Vijayalakshmi has said no contamination was found in samples from unopened eye drops manufactured by the Chennai plant.
"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 said.
Vijayalakshmi refused to comment on the US watchdog's remarks on the eyedrops.
The Centers for Disease Control and Prevention (CDC), the top medical watchdog in the US, has linked the eyedrops to the likelihood of a highly drug-resistant bacteria gaining a foothold in the US. The US Food and Drug Administration recently released a report of their inspection of the manufacturing facility, making several observations of irregularities in the manufacturing process
In February, the FDA had issued a warning to US consumers and health care practitioners not to purchase and to immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
Three deaths, eight cases of blindness and dozens of infections were reportedly traced to eyedrops made by Global Pharma Healthcare under the brand name EzriCare Artificial Tears, The New York Times had reported, citing the CDC.
Infectious disease specialists said this drug-resistant bacteria strain had not been previously detected in the US and was particularly difficult to treat with the antibiotics currently available, the newspaper reported.
Global Pharma Healthcare, which is located about 40 km south of Chennai, had stopped the production of the eyedrops linked to the US market in February and voluntarily recalled unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears at the consumer level.
The Tamil Nadu drugs regulator had then found "no evidence of deviation" at the Chennai plant in February.