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Indiana Ophthalmics has been showcaused by the Pharmaceuticals Export Promotion of India (Pharmexcil) following a recall of its eye drops by the Sri Lankan Health Ministry due to adverse events possibly linked to the product.
The Gujarat-based company, registered with Pharmexcil as a small-scale manufacturer, has been asked by the agency to investigate the reasons for the alleged contamination and take action. It has till June 3 to respond, following which it could face suspension of its registration and membership, according to Pharmexcil’s letter to the company.
The company has also been asked to provide details of licensees it has supplied to; importer details and, manufacturing license copies and product permissions.
The Pharmexcil showcause to the company follows reports of India’s Central Drugs Standard Control Organisation (CDSCO) also investigating reports of the allegedly contaminated eye-drops (methylpredisolone) affecting about 30 people in Sri Lanka. The Sri Lankan cabinet is also said to have discussed the issue, including a possible compensation payment to the patients by the company, the Pharmexcil Director General’s letter pointed out.
The development comes on the heels of multiple international incidents of alleged contamination of cough syrups and their potential links to the deaths of children in Gambia and Uzbekistan. The latest incident in Sri Lanka is the second involving eye-drops. An earlier incident in the United States traced back to an India-based eyedrops maker.
In fact, given these recent incidents, the Centre had recently mandated companies to test their cough syrups before exporting, starting today (June 1). Echoing the concern of many industry-watchers, the Pharmexcil letter says the supply of such contaminated products would not only bring a bad reputation to the Indian pharmaceutical industry but also impact the trust international agencies have in Indian pharma exports.
Indiana Opthalmics claims on its homepage to be among the country’s largest eyedrops and eye ointment makers, with a WHO-GMP (Good Manufacturing Practices) certification since 2007.
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