ugc_banner

Indian drug controller probes medicines exported to Sri Lanka following reports of vision loss

New Delhi, India Edited By: Heena SharmaUpdated: Jun 05, 2023, 05:51 PM IST
main img
Representative Image Photograph:(Twitter)

Story highlights

Indian eye drops exported to Sri Lanka: Apart from eye drops, the WHO has also highlighted three instances of diethylene or ethylene glycol contamination in Indian-manufactured syrups since October last year. These syrups have been linked to 70 deaths in Gambia and 18 deaths in Uzbekistan.

The Indian drug controller is currently investigating a pharmaceutical company based in Gujarat after receiving reports from Sri Lanka that a steroid eye drop manufactured by the firm has been associated with adverse events, including cases of vision loss. Meanwhile, the Sri Lankan government has recalled the medicine, as per media reports. 

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has issued a notice to the company, requesting information regarding the importer, recipients of the drug, and details about the manufacturing license and product permissions.

The company, Indiana Ophthalmics from Wadhwan-Gujarat, has been urged to investigate the cause of the alleged product contamination and provide their findings to take appropriate action. 

Failure to submit the requested information by June 3, 2023, could result in the suspension of the company's Registration-cum-Membership Certificate (RCMC), Pharmexcil said. 

An RCMC is required by companies to export drugs, and if the necessary information is provided, Pharmexcil will await the investigation findings before taking further action.

Eye drop given to cataract patients post-surgery 

According to reports, the prednisolone eye drop in question was administered to patients in Sri Lanka who had undergone cataract surgery. The eye drop has been linked to "eye infections in over 30 individuals," as mentioned in the Pharmexcil notice.

Earlier cases of Indian-manufactured eye drop

This is not the first instance of contamination involving an eye drop manufactured in India. Earlier this year, the US was investigating the EzriCare Artificial Tears, an over-the-counter eye drop produced by Global Pharma Healthcare in Chennai, India. The investigation centred around a widespread outbreak of a highly resistant strain of bacteria that has been associated with different types of infections, including those affecting the eyes.

The US reported an outbreak of highly antibiotic-resistant bacterial infections linked to the Indian-manufactured eye drop. The outbreak reportedly resulted in 68 cases of infection across 16 states, causing three deaths, eight cases of vision loss, and four cases of eyeball removal.

The company voluntarily recalled the eye drops in February.

Indian-manufactured ophthalmic ointment 

In another incident, the World Health Organization (WHO) issued an alert regarding an Indian-manufactured ophthalmic ointment in February, citing quality issues such as the presence of particles in various colours, sizes, and shapes of the nozzle, cap, and inside tubes.

The ointment is given as a treatment to infants and older children and is also indicated as a preventive measure for infants. As per WHO, the affected ointment is supplied in bulk and as a component of various medical kits supplied by some international organisations providing humanitarian assistance. At least 55 countries received the affected batches, as per the global health agency. 

Watch | Pakistan to begin barter trade with Afghanistan, Iran and Russia

Additionally, black spots and brown splotches were found on the inner foil layer of the tubes. However, the WHO clarified that no adverse events were associated with the ointment. "Redness and swollen eyes are common reactions to the general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling," WHO had said. The manufacturer initiated a voluntary recall of several batches.

Indian-manufactured syrups 

Apart from eye drops, the WHO has also highlighted three instances of diethylene or ethylene glycol contamination in Indian-manufactured syrups since October last year. These syrups have been linked to 70 deaths in Gambia and 18 deaths in Uzbekistan.

Furthermore, a case of contamination was detected in the Marshall Islands and Micronesia, despite the manufacturer claiming that the syrups were never sold to these countries.

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

×