The national public health agency of the United States Centers for Disease Control and Prevention has expressed concern over a drug-resistant bacteria strain allegedly linked to eye-drops imported from India could gain a foothold in U.S. health care settings.

The manufacturer of the drug, EzriCare eye-drops, a Global Pharma Healthcare. The Healthcare is at the centre of a United States investigation into a multistate outbreak of an extensively drug-resistant bacterium strain associated with multiple types of infections including eye infections.

The outbreak strain — VIM-GES-CRPA, a rare strain of the extensively drug-resistant Pseudomonas aeruginosa bacterium, and never been reported before in the US. The strain has been detected in 68 cases from 16 states, according to the CDC. Of these, 37 patients were linked to four healthcare facility clusters. Three people have died and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of eyeball).

The CDC conclusion is based on its investigations at healthcare centres from where the cases were reported and testing of opened bottles of the eye drops.

The CDC tested open bottles of the eye drops and found contamination in multiple lots.

As per CDC, “If the product was not sealed completely, contamination could occur during transportation or storage. However, the widespread nature of the outbreak strain suggests a point source and not contamination at multiple points along storage and distribution pathways,” the CDC said.

The Indian drug regulator, which had collected control samples from the manufacturing plant near Chennai, found no contaminants in the eye drops, according to sources. Control samples are samples from the batches exported and maintained by the company as part of quality control processes.

Sources in the Union Health Ministry said similar samples were collected by the US FDA in India and were tested at an approved laboratory in Bengaluru.

These samples also did not have contaminants, a Health Ministry official said.

Source: IndianExpress