The Indian drug controller is currently conducting an investigation into an pharmaceutical company in Gujarat based on reports from Sri Lanka indicating that a steroid eye drop produced by the company has been associated with adverse events, including cases of vision loss. The Sri Lankan government has recalled the medicine in response to these reports.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has issued a notice to the company, Indiana Ophthalmics from Wadhwan-Gujarat, requesting information about the importer, recipients of the drug, and details regarding the manufacturing license and product permissions. The company has been urged to investigate the alleged product contamination and provide their findings to take appropriate action.
Pharmexcil has stated that failure to provide the requested information by June 3, 2023, may result in the suspension of the company’s Registration-cum-Membership Certificate (RCMC), which is necessary for exporting drugs. Pharmexcil will await the investigation findings before taking further action if the required information is provided.
The prednisolone eye drop in question was administered to cataract patients in Sri Lanka. The eye drop has been linked to eye infections in over 30 individuals, as mentioned in the Pharmexcil notice.
This is not the first instance of contamination involving an eye drop manufactured in India. In a previous case, the US investigated the EzriCare Artificial Tears eye drop produced by Global Pharma Healthcare in Chennai, India. The investigation was prompted by an outbreak of highly antibiotic-resistant bacterial infections associated with the eye drop, resulting in several cases of infection, vision loss, and even eyeball removal.
In another incident, the World Health Organization (WHO) issued an alert regarding an Indian-manufactured ophthalmic ointment due to quality issues, including the presence of particles in various colors, sizes, and shapes on the nozzle, cap, and inside the tubes. The ointment is used to treat infants and older children, as well as for preventive measures in infants. The affected ointment was supplied in bulk and as part of medical kits distributed by international organizations providing humanitarian assistance. The WHO reported that at least 55 countries received the affected batches.
The WHO also highlighted instances of diethylene or ethylene glycol contamination in Indian-manufactured syrups, which have been linked to numerous deaths in various countries. Several cases of contamination were detected, leading to concerns about the safety and quality of these products.
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