Chennai pharma recalls eye drop after infections in US, unit’s inspection on

“It is a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India,” sources from the Health ministry said. The company in its announcement said that the eye drop was distributed by ErziCare and Delsam Pharma.

The medicine, which is used to relieve irritation or dryness of the eye, is sold over-the-counter. “The product was distributed nationwide in the US over the internet,” the company said in its statement.

The Centre for Disease Control and Prevention reported the multi-state cluster of a bacteria called pseudomonas aeruginosa that was resistant to third-line antibiotic called Carbapenem.

Unlike the incidents in the Gambia and Uzbekistan, where the manufacturing was stopped by Indian authorities after concerns were raised, the Chennai company recalled the product themselves. The process followed by the Indian regulator was, however, the same with an inspection of the plant being carried out soon after the reports.

After similar inspections found the companies in Haryana and Uttar Pradesh not adhering to good manufacturing practices, the facilities were shut down by the Indian regulator. A risk-based inspection of drug manufacturing companies was carried out thereafter.

In Uzbekistan, 18 children died of kidney failure allegedly after consuming two syrups manufactured by Marion Biotech. While in the Gambia, the deaths of 70 children due to acute kidney injury were linked to four syrups manufactured by Maiden pharma. In both cases, the syrups allegedly contained the contaminants — di-ethylene glycol and ethylene glycol.