CDCSO Investigating Gujarat-Manufactured Eye Drops That 'Caused Infections' in Sri Lanka

These eye drops were recalled by Sri Lanka's Ministry of Health in April this year with "immediate effect".

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) is reportedly investigation eye drops manufactured by Gujarat-based Indiana Ophthalmics which have allegedly caused eye infections in more than 30 people in Sri Lanka.

According to News18, these eye drops were recalled by Sri Lanka’s Ministry of Health in April this year with “immediate effect”, because patients at the country’s largest tertiary care hospital were reporting complications after using them.

The eye drop was found to contain the bacteria Burkholderia cepacia, according to The Sunday Guardian. The report also said that the Sri Lankan government has asked to company to compensate the affected patients.

The Sri Lankan government has also asked the Indian government to look into the matter, News18 reported. “We have been informed that an eyedrop imported from India by the ministry of health of Sri Lanka has been withdrawn. It is alleged that a few patients developed bacterial infections after using the methylprednisolone eyedrops,” a government official told News18. “We are also informed that the number of affected patients may be as high as 35 and the matter was discussed by the cabinet of government of Sri Lanka.”

State drug officials have tested the drops and are waiting for results, the report said.

“The test results will take another ten days as these drugs require sterility testing which requires around 15 days. Once the results are out, the Indian ministry of health will send the detailed investigation report to the health ministry of Sri Lanka,” News18 quoted another official as saying.

This is not the first time in the recent past when eye drops manufactured in India have come under scrutiny abroad. As The Wire has reported, in February this year, the production of all 14 ophthalmic solutions was stopped at Tamil Nadu-based Global Pharma Healthcare – a firm whose product has been potentially linked with contamination causing blindness and one death in the US. As many as 55 people were reported to be affected.