Central Drugs Standard Control Organisation bars Tamil Nadu-based firm from making eye lubricant
The HinduThe Central Drugs Standard Control Organisation has instructed Tamil Nadu-based Global Pharma Healthcare to stop manufacturing all the products under the category of ophthalmic preparation till the completion of an investigation. The move came soon after the U.S. Centers for Disease Control and Prevention linked the company’s eye drops to 55 adverse events in the U.S. On Friday, a joint team — comprising senior drug inspectors and officials from the Centre and from Tamil Nadu — visited the company’s manufacturing premises. They collected samples from four batches of “control samples” for analysis and that of the raw material, carboxymethylcellulose sodium, which was used for manufacturing the eye lubricant. The investigation was launched on the basis of a warning by the CDC that the eye drops supplied by the company to distributors Aru Pharma/EzriCare and Delsam Pharma in the U.S. had been linked to adverse events, including eye infections, permanent loss of vision, and a death with a bloodstream infection.
History of this topic
Drug regulator suspends pharma firm from manufacturing eye drops claiming to replace reading glasses
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Pharmexcil seeks explanation from eye drops maker flagged by Sri Lanka
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CDSCO starts probe into Indian-manufactured eye drops leading to infection
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Centre Probes Gujarat Pharma Firm Over Its Eyedrops Being Linked to Vision-damage Cases in Sri Lanka
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India seeks information from USFDA/CDC on alleged contamination of eye drops
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US authorities issue scathing report on eye drops made in India
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CDC concerned about drug-resistant bacteria strain allegedly linked to eye-drops imported from India
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Chennai-based company’s eye drops linked with 55 adverse events in United States
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Chennai-based drug firm recalls eye drop linked to vision loss in US
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