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After Pharma Firm's Huge Eye Drop Claim, Regulator Withdraws Permission
NDTV
The DCGI said the company made claims for the product for which it had not obtained approval from the Central Licensing Authority, violating provisions under the New Drugs and Clinical Trial Rules, 2019
Taking serious note of Mumbai-based Entod Pharmaceuticals' claims that it can help reduce dependency on reading glasses for those suffering from presbyopia, the Drugs Controller General of India (DGCI) has suspended permission given to the company to manufacture and sell their new eye drop, PresVU.
According to the National Eye Institute, presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close.
The DCGI said the company made claims for the product for which it had not obtained approval from the Central Licensing Authority, violating provisions under the New Drugs and Clinical Trial Rules, 2019.