Failing to get any response from the Indian drug regulators, the Sri Lankan government has stopped procuring eyedrops from Gujarat-based Indiana Ophthalmics due to quality issues.
The country’s government had flagged the methylprednisolone eye drops of this particular brand three months back, after 50 people were reportedly infected there following their use, with two people losing their vision.
Sri Lanka had written to Indiana Ophthalmics, the Mumbai-based supplier Alvita Pharma and the Indian drug regulator about it, but didn’t get any response from them. The island nation’s National Medicines Regulatory Authority (NMRA) then informed the World Health Organization (WHO) about laboratory reports that revealed bacterial contamination in the eye drops.
Ironically, despite the serious lapse, the company continues to manufacture and export the same eyedrop to over 30 countries. The Gujarat Food and Drug Administration has reportedly issued a notice to Indiana Ophthalmics, but allowed it to continue its manufacturing and exports.
Sources said, a team of drug inspectors had visited the Wadhwan plant of Indiana Ophthalmics in Surendranagar but found “no major deviation” in manufacturing practices. Sri Lankan authorities, however, said their probe had established beyond doubt that the eye drops were responsible for the infection.
Indian pharma companies manufacturing ophthalmic products being flagged for quality issues is not new.
In January, the United States announced an alert against Global Pharma over contaminated eye drops that led to infections in 68 patients and four deaths. It also found several lapses in the manufacturing process of the Chennai-based company.
In February, WHO issued a medical alert against Galentic Pharma from Maharashtra over poor quality eye ointment. The alert forced non-profit Médecins Sans Frontières and UNICEF to stop procurement from the company.
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