Indiana Ophthalmics faces CDSCO probe; Pharmexcil may suspend membership

CDSCO starts probe based in complaint by Sri Lanka that eyedrops made by the firm are linked to eye infections in more than 30 people

Trouble for Indian drug exporters continues with the Central Drugs Standard Control Organisation (CDSCO) investigating a complaint raised by Sri Lanka that eye drops made by a Gujarat-based firm are linked to eye infections in more than 30 people in the neighbouring country. Moreover, Indiana Ophthalmics, the Gujarat-based manufacturer, has now received a show-cause notice from the Pharmaceutical Exports Promotion Council (Pharmexcil). Its membership may be cancelled if it fails to respond by Saturday.

Indiana Ophthalmics is registered with the National Medicines Regulatory Authority of Sri Lanka and has been supplying prednisolone eye drops that are used to treat inflammation of the eyes caused by certain conditions for several years now. A source said the samples from the company have been sent for testing by CDSCO officials and it may take up to 10-15 days to get the reports on sterility etc.

In April Sri Lanka’s health ministry issued a directive and the eyedrops were recalled with immediate effect. Around 14 patients who underwent cataract surgery in a Sri Lankan hospital reported poorer vision after using the eyedrops made by Indiana Ophthalmics. The eyedrops have been linked to eye infection and complications in more than 30 people.

The matter was discussed in the Sri Lankan Cabinet on May 16 where the President directed the health minister to investigate the matter. Further the issue of the Indian company paying compensation to affected patients was also discussed.

In his letter to Indiana Ophthalmics dated June 1, Udaya Bhaskar, director general of Pharmexcil, which comes under the Union Ministry of Commerce and Industries has noted that the company has brought ‘bad reputation’ and is likely to have an impact on the ‘trust’ of international agencies on Indian Pharma exports.

Bhaskar has given a deadline of June 3 in his letter to the MD of Indiana Ophthalmics Nirav R Bhatt to respond to the notice with required information, failing which the company’s registration cum membership certificate (RCMC) will be suspended without any further notice. This would make the company ineligible for incentives under the Market Access Initiative Scheme.

Pharmexcil has sought details on licensees to whom the product was supplied, the details of importers and also copies of manufacturing license and product permission of the products under review.

Pharmexcil had earlier suspended the membership of Marion Biotech whose cold medication was linked to the deaths of 18 children in Uzbekistan. Since October last year, Indian exporters have been under fire and several cases of sub-standard or contaminated drugs made in India and supplied to Gambia, Uzbekistan, Marshall Islands, Micronesia have been reported.