A Gujarat-based firm, Indiana Ophthalmics has been accused of supplying poor-quality eye drops in Sri Lanka.
According to media reports, The Pharmaceuticals Export Promotion Council of India (Pharmexcil) issued a show cause notice on June 1 to the firm. This is after the Sri Lanka government wrote a complaint to its Indian counterpart and said that 30 people have gotten an eye infection.
Pharmexcil has sought an explanation from the Gujarat-based firm on the internal investigation within the next two days, the reports said.
Uday Bhaskar, Director General of Pharmexcil, in the notice, expressed concerns that the alleged supply of contaminated eye drops has impacted the image of India's pharmaceutical industry, and it may impact the trust that international agencies have in Indian pharma exports.
Indiana Ophthalmics has been asked to investigate the matter internally and provide an update by June 3 to the export council.
According to the reports, the show cause notice stated that failure to submit the requested information by June 3 would result in the suspension of Indiana Ophthalmics' Registration cum Membership Certificate (RCMC) without further notice.
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Nirav R. Bhatt, Partner at Indiana Ophthalmics, has been specifically asked to provide the details and copies of manufacturing licences, and product permissions, along with details of the licencees to whom the eye drops were supplied in Sri Lanka.
An investigation has also been initiated by the Central Drugs Standard Control Organisation (CDSCO).
In April 2023, Sri Lanka's Health ministry lodged a complaint with the Indian government, stating methylprednisolone eye drops supplied by Indiana Ophthalmics to eye infections in over 30 individuals in Sri Lanka.
The show cause notice issued to Indiana Ophthalmics mentioned that the issue of poor-quality eye drops was discussed during a Sri Lankan cabinet meeting on May 16, 2023. Sri Lanka's health minister was directed to conduct investigations and offer compensation to the affected patients.