Tamil Nadu drug regulator says 'no contamination found' in Indian eyedrops after US raises alarm

The drug regulator in the south Indian state of Tamil Nadu has junked media reports which claimedthat a Chennai-based pharmaceutical company's eyedrops caused eye infections and blindness in the US.

Speaking to Indian news outlet NDTV, the director of the Tamil Nadu Drugs Control, PV Vijayalakshmi, said that no contamination was found in samples from unopened eyedrops manufactured at 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 was quoted as saying.

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The remarks came after the top US medical body, Centers for Disease Control and Prevention (CDC), expressed alarm over the spread of a drug-resistant superbug linked to eyedrops and an eye ointment made by the Indian pharmaceutical company,Global Pharma Healthcare.

Experts have said that the strain, which was recently detected in the United States, cannot be treated with existing antibiotics, reported New York Times newspaper.

In recent months, eight cases of blindness and dozens of infections have been traced to EzriCare Artificial Tears, made by Chennai-based Global Pharma Healthcare, the NYT reported on Monday.

The Food and Drug Administration (FDA), which regulates over-the-counter medicines in the US, and the CDC have issued advisories against the use of EzriCare Artificial Tears, warning that they may be linked to an outbreak of ‘Pseudomonas aeruginosa.’

Pseudomonas bacteria causes infections in the blood, lungs or other parts of the body after surgery.

The FDA stopped imports of the product after the Indian pharma company in February recalled the potentially dangerous eyedrops from the US market.

According to medical experts, the bacteria linked to drug-resistant Pseudomonas aeruginosa is already a top concern for healthcare providers, as it affects those with compromised immune systems, nursing home residents and patients with invasive medical devices like catheters and breathing tubes.

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An infectious disease specialist at the University of North Carolina School of Medicine, Dr David van Duin, told NYT that it is difficult to neutralise the drug-resistant bacteria from health care facilities, where it clings tenaciously to sink drains, water faucets and other moist environments, and from patients who develop bloodstream infections.

A possible outbreak due to the eyedrops have been largely contained. Moreover, the CDC has been asking doctors to work with public health labs to determine the genetic fingerprint of hard-to-treat Pseudomonas infections in the eye and throughout the body.

Additionally, the FDA has ordered to recall Delsam Pharma’s Artificial Eye ointment, which was made in the same factory as the eyedrops, because of possible contamination.

The health agency has blocked Global Pharma’s imports, saying that the company provided “an inadequate response to a records request” and violated manufacturing rules.

After facing criticism over lapses, the FDA conducted an unannounced inspection at the India plant between February 20 and March 2. It found “a litany of problems with the plant’s sterility practices", the NYT report states citing an inspection report published by STAT news.

Moreover, the Indian government also conducted raids at the units Global Pharma Healthcare on February 3.

In a statement, the company said that it was recalling all its products due to possible contamination.

This is the second time an Indian pharma has come under the spotlight over its “substandard"products. Recently, a firm from Uttar Pradesh landed under scrutiny after dozens of deaths were reported among children in Gambia and Uzbekistan last year after consuming cough syrups.

(With inputs from agencies)

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