Drug controller investigating medicine exported to Sri Lanka after loss of eye sight complaint
Posted on June 2nd, 2023

Courtesy Indian Express

According to an official, if the company supplies the necessary information then the body will wait for findings of investigation for further action.

The Indian drug controller is investigating a Gujarat-based pharmaceutical company after receiving communication from neighbouring Sri Lanka that a steroid eye drop manufactured by the firm has been linked to adverse events including loss of eye sight.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has also issued a notice to the company seeking details of the importer, those who the drug has been supplied to, and manufacturing licence and product permission.

You are further advised to investigate the reasons for contamination of the alleged product at your end and update us with your findings at the earliest to take necessary action. Upon failure of submission of requested information by 3rd June 2023, your Registration-cum-Membership Certificate (RCMC) will be suspended without any further notice,” read the notice to Indiana Opthalmics from Wadhwan-Gujarat. Calls to the company went unanswered.

A company cannot export drug without an RCMC from Pharmexcil. According to an official, if the company supplies the necessary information then the body will wait for findings of investigation for further action.

The prednisolone eye drop was administered to patients in Sri Lanka reportedly after undergoing cataract curgery. The eye drop has been linked to eye infection in more than 30 people,” according to the Pharmexcil notice. The Sri Lankan government recalled the medicine.

This, however, is not the first instance of an India-manufactured eye drop found to be contaminated. The United States had earlier this year linked an India-manufactured eye drop to an outbreak of a highly antibiotic resistance bacterial infection outbreak in the country. There were 68 cases of the infection reported from 16 states, leading to at least three deaths, eight cases of vision loss, and four cases of removal of eyeballs. The company had initiated a voluntary recall of the drops in February.

Other than this case, the WHO had also raised an alert for an India manufactured ophthalmic ointment in February, stating international procurers had detected quality issues such as particles ranging in colour, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube. The WHO, however, clearly stated that there were no adverse events linked to the ointment. The manufacturer initiated a voluntary recall of several batches.

Other than eye formulations, three instances of di-ethylene or ethylene glycol contamination in India-manufactured syrups have been highlighted by the WHO since October last year. The syrups have been linked to 70 deaths in Gambia and 18 deaths in Uzbekistan. The third was detected in Marshall Islands and Micronesia even as the manufacturer maintains that the syrups were never sold to these countries.

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