Blindness Caused By Eye Drops Manufactured in India, the Country Where Recalled EzriCare Artificial Tears is Manufactured
The pharmaceutical company based in Gujarat, India, is currently under investigation by the Indian drug controller. The investigation was prompted by reports from Sri Lanka indicating that a steroid eye drop manufactured by the company has been associated with adverse events, including instances of vision loss. Media reports state that the Sri Lankan government has recalled the medicine.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has issued a notice to the company, Indiana Ophthalmics from Wadhwan-Gujarat. The notice requests information about the importer, recipients of the drug, as well as details regarding the manufacturing license and product permissions.
Pharmexcil has urged the company to investigate the alleged product contamination and determine its cause. They have also requested that the company provide their findings to take appropriate action. Failure to submit the requested information by June 3, 2023, could lead to the suspension of the company’s Registration-cum-Membership Certificate (RCMC), according to Pharmexcil.
An RCMC is a requirement for companies exporting drugs. If the necessary information is provided, Pharmexcil will await the investigation findings before proceeding with further action.
The prednisolone eye drop in question was administered to patients in Sri Lanka who had undergone cataract surgery. According to reports, over 30 individuals who received the eye drop have developed eye infections, as stated in the Pharmexcil notice.
This incident is not the first case of contamination involving an eye drop manufactured in India. Earlier this year, the United States investigated the EzriCare Artificial Tears, an over-the-counter eye drop produced by Global Pharma Healthcare in Chennai, India. The investigation focused on a widespread outbreak of a highly resistant strain of bacteria, which caused various types of infections, including eye-related conditions.
The US reported 68 cases of infection across 16 states, resulting in three deaths, eight cases of vision loss, and four cases of eyeball removal. The company voluntarily recalled the eye drops in February.
In February, the World Health Organization (WHO) issued an alert regarding an Indian-manufactured ophthalmic ointment. The alert highlighted quality issues such as the presence of particles in different colors, sizes, and shapes in the nozzle, cap, and inside tubes of the ointment. The ointment is used for the treatment of infants and older children and is also recommended as a preventive measure for infants. The affected ointment was supplied in bulk and as part of medical kits provided by international organizations involved in humanitarian assistance. According to the WHO, at least 55 countries received the affected batches.
The inner foil layer of the tubes showed black spots and brown splotches, but the WHO clarified that no adverse events were associated with the ointment. The WHO stated that redness and swollen eyes are common reactions to the general use of tetracycline eye ointment. The quality issues mentioned are not expected to cause adverse events that are not already listed in the product labeling. The manufacturer initiated a voluntary recall of several batches.
In addition to the eye drops and ointments, the WHO has highlighted three instances of diethylene or ethylene glycol contamination in Indian-manufactured syrups since October of the previous 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.
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