The Central Drugs Standard Control Organisation has launched an investigation into an eye drop manufactured in Gujarat has been linked with an infection in more than 30 patients in Sri Lankan hospitals.
The patients developed complications after prednisolone eye drops were administered to them following cataract surgery in April, The Hindu reported.
The eye drops are manufactured by Indiana Ophthalmics, which is registered with the National Medicines Regulatory Authority of Sri Lanka and has been supplying the medicine since 2017. After the incident, the eye drops were recalled with “immediate effect” by the Sri Lanka Ministry of Health, according to The Hindu.
Deputy Director General (Medical Supplies) Dr DRK Herath told Scroll that the infections were reported from at least two hospitals in Colombo – National Eye Hospital and Novaradina Hospital.
“Both [hospitals] were using the same product from the same batch,” Herath said. “Our regulatory body is in touch with the Indian counterparts.
Hemant Koshia, the joint commissioner of Gujarat state Food and Drug Control Administration, told Scroll that none of the products of Indiana Ophthalmics has been found to be substandard quality in the past. He added that the state regulator has not stopped the company from manufacturing the drug yet.
“It is also possible that the infection was acquired in the hospital,” Koshia said. “We will wait until the CDSCO [Central Drugs Standard Control Organisation] tests the product before deciding further action.”
Cloud over Indian drugs
India’s image of being the “pharmacy of the world” has been dented after several incidents of drugs manufactured in the country have come under scrutiny abroad, especially due to deaths of children in The Gambia and Uzbekistan.
Last year, the authorities in The Gambia had had linked the deaths of 70 children, most of them due to acute kidney failure, to medicines manufactured by Indian-based Maiden Pharmaceuticals. After this, a cough syrup manufactured by Indian-based Marion Biotech Limited was linked with the deaths of 18 children in Uzbekistan in December.
In April, the US Food and Drug Administration had found a series of violations in the manufacturing process and sterilisation methods adopted by Global Pharma, the Indian manufacturer of an eye drop that has been linked to 68 cases of eye infection in America, including eight cases of vision loss and three deaths. The product, EzriCare Artificial Tears Eye Drop, was recalled in February.
A month before this, India’s Central and state drug regulators had cancelled or suspended licences of 18 companies as part of action taken against pharmaceutical firms for producing spurious or adulterated medicines.
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