The Sri Lankan ministry of health filed a complaint with the Central Drugs Standard Control Organisation (CDSCO) alleging that eyedrops made in India are responsible for more than 30 cases of eye infections on the island nation.
The eyedrops were produced by Indiana Ophthalmics, a company with its headquarters in Gujarat that has been supplying the same product for the past seven years and is registered with Sri Lanka’s National Medicines Regulatory Authority.
HOW TROUBLE BEGAN
The Sri Lankan Ministry of Health issued a directive in April ordering the recall of eyedrops imported from India with “immediate effect” after patients at the nation’s largest tertiary care hospital began reporting complications.
After completing the internal investigations, the Sri Lankan ministry has now requested the Indian government “to look into the matter urgently”.
“We have been informed that an eyedrop imported from India by the ministry of health of Sri Lanka has been withdrawn.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 privy to the development told to sources. “We are also informed that the number of affected patients may be as high as 35 and the matter were discussed by the cabinet of government of Sri Lanka.”
The official said that these eyedrops were supplied to the state pharmaceutical corporation of Sri Lanka in March 2023. “So far, two batches of the medicine have been withdrawn. Almost two weeks ago, the ministry of health and family welfare was requested to look into this matter urgently and therefore, the Central Drugs Standard Control Organisation (CDSCO) was instructed.”
The samples of the medicine have been taken by the state drug officials and now the test results are awaited.
PRELIMINARY INQUIRY AND RESULTS SENT TO INDIAN GOVT
In April, the cases of infection were noted among people who had undergone surgery at the Nuwara Eliya District General Hospital.
“On preliminary inquiry, the hospital confirmed that 14 out of 34 patients who underwent cataract surgery since April 5 complained of reduced vision after use of methylprednisolone eyedrops from India,” said the reliable source quoted above.
The official claimed that after a few patients complained of complications and tests revealed that there was evidence of bacterial growth present, the Indian government was informed that these eyedrops had been sent for culture in order to detect the presence of bacteria.
“The hospital also conveyed that among the 14 patients who developed complications, permanent loss of vision was reported in one. However, other patients under treatment are recovering,” he said.
Later, Sri Lankan authorities informed that the number of affected patients may be as high as 35.
“The matter was also discussed during the Sri Lankan cabinet meeting on May 16, 2023 where the President had directed the minister of health to conduct investigations and inquiries at the earliest,” said the official. “The matter of paying compensation to the patients by the Indian company was also raised.”