India‘s drug regulatory authority has initiated a probe after a popular eye drop supplied by an Indian company allegedly caused severe damage to the eyesight of patients in Sri Lanka.

Several patients in Sri Lanka developed complications earlier in May, allegedly after the use of ‘Prednisolone’, an eye drop administered to them following cataract surgeries at government hospitals. According to information received by India’s health ministry, the number of such patients may be as high as 35. “The issue was discussed by the Cabinet of the government of Sri Lanka widely after which the Indian health ministry asked the CDSCO (Central Drugs Standard Control Organisation) to initiate a probe,” a person aware of the matter told ET.

The batches were withdrawn soon after, he said.

The eye drop was manufactured by Gujarat-based Indiana Ophthalmics and supplied by Mumbai’s Alvita Pharma.

“The investigation has started. Samples of the medicine have been picked up along with the invoice and other important documents. The samples will be sent to the CDL (Central Drugs Laboratory) for investigation,” a government official said.

Indiana Ophthalmics could not be reached immediately for comment.An Alvita Pharma executive told ET that the product had been tested by the manufacturer and at an NABL-accredited lab in India, and the results had been found satisfactory.”We wish to inform you that in the above matter, our company is only a supplier. Indiana Ophthalmics is the manufacturer for more than 30 years. The manufacturer is officially registered in Sri Lanka MOH (ministry of health) and has been supplying the same products for the last seven years,” he said. On receipt of the complaint, Alvita Pharma has informed the manufacturer to investigate further and send the details to the MOH in Sri Lanka, he said.

According to the executive, the manufacturer has already submitted an investigation report with test results from NABL-approved labs to Sri Lanka’s MOH. “The Sri Lankan government has withdrawn the batch pending investigation,” he added.

The company has not received any official communication regarding compensation as yet, he said. This is not the first time when an Indian drug company has come under scrutiny over the eye drops supplied abroad.