Centre Probes Gujarat Pharma Firm Over Its Eyedrops Being Linked to Vision-damage Cases in Sri Lanka

The Central Drugs Standard Control Organisation (CDSCO) is investigating a complaint raised by the Sri Lankan ministry of health where India-made eyedrops are linked to causing eye infections in more than 30 people in the island nation.

The eyedrops were manufactured by Gujarat-based Indiana Ophthalmics – a company that has been registered with the National Medicines Regulatory Authority of Sri Lanka and supplying the same product for the last seven years.

How trouble began

In April, the eyedrops imported from India were recalled with “immediate effect” as per the directive issued by the ministry of health of Sri Lanka after patients  at the country’s largest tertiary care hospital started 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“We have been informed that an eyedrop imported from India by the ministry of health of Sri Lanka has been withdrawn.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 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.”

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 “So far, two batches of the medicine have been withdrawn.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.

“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,” another senior official involved in the investigation said.

News18 reached out to the secretary, ministry of health, Sri Lanka, and Dr DRK Herath, chief of medical supplies division of ministry of health, Sri Lanka, via email but is yet to receive a reply.

The official spokesperson of the Indian ministry of health and family welfare did not respond to the text message seeking an official reaction over the complaint.

A mail was also sent to Indiana Opthalmics along with text messages to Nirav Bhatt, managing director of the firm. Both went unanswered.

“The manufacturer has already submitted a detailed investigation report with test results from NABL-approved labs to the Sri Lankan ministry of health,” the second official quoted above said.

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 second source quoted above.

The official said that the Indian government has been informed that these eyedrops were sent for culture – to detect presence of bacteria – after a few patients complained of complications, which came out to be positive for bacterial growth presence.

“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.”

Litany of cases

The move, once again, puts a question mark on the manufacturing quality of made-in-India medicine. Starting October 2022, multiple allegations have been levelled by importers of Indian medicines, especially cough syrups, including Uzbekistan, the Gambia, Marshall Islands, and Micronesia, where made-in-India syrups were found contaminated with toxic diethylene glycol (DEG) and ethylene glycol (EG).

In February, the US Food and Drug Administration had warned against using an India-made eyedrop that was linked to the outbreak of a drug-resistant bacteria.