Financial Daily from THE HINDU group of publications
Wednesday, May 24, 2006
Financial Daily from THE HINDU group of publications Wednesday, May 24, 2006 |
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Corporate
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Standards & Benchmarks Industry & Economy - Health MoistureLoc recall throws up need for independent reporting system P.T. Jyothi Datta
Mumbai , May 23 It was in February that the first signs of trouble were visible with Bausch & Lomb's MoistureLoc contact lens solution in Singapore. As cases of serious fungal eye infection - fusarium keratitis - started getting reported from Asia and the US, respective health regulatory authorities initiated investigations to probe if the infections were linked to the specific contact lens solution. In India, Bausch & Lomb affirmed that no such eye infections had occurred in the country. And last week, the company globally took off the shelf its ReNu with MoistureLoc contact lens solution to reduce the risk of the rare eye infection.
No Monitoring
Nevertheless, the nagging thought remains. Was there zero incidence of similar eye-infections in India because there were no such cases reported here or because there is no independent monitoring system to capture such data? Both, says Ms Kunda Ganatra, President of the Indian Optometric Association (IOA). There is no regulatory body to which such medical device linked incidents can be reported. However, similar infections have not been seen in the private hospitals and clinics, she says, adding that the IOA has been keeping an eye on developments. The association met Bausch & Lomb officials in Mumbai last week. Only recently the Union Health Ministry brought select medical devices, including intra-ocular or implantable contact lenses under the purview of the Drugs and Cosmetics Act. But contact lenses and their solutions still sit outside the regulatory ambit, admits a Health Ministry official.
Product recall
A Bausch & Lomb spokesperson told Business Line that regulatory authorities - the Drug Controller General of India at the Centre and the State Food and Drug Administration - were kept informed about the product recall. Opthalmologists and the trade too have been sent communication from Bausch & Lomb keeping them in the loop on MoistureLoc, the official said. But that is the problem, observes a healthcare industry expert. Every time a global brand is recalled, be it stents or contact lens solutions, one has to depend on the company to get data, he points out. According to the US Centers for Disease Control and Prevention, more than 100 cases of serious eye infection have been reported and are under investigation for links to Bausch & Lomb's MoistureLoc solution. More than 30 cases are under investigation in Asian markets such as Singapore, say agency reports. But Bausch & Lomb's spokesperson says no unusual incidence of fungal eye infections were reported in India. This is based on consultations with key referral centres such as LV Prasad Eye Institute, Hyderabad and the All India Institute of Medical Sciences, the company said.
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