NEW DELHI: The Drug Controller Common of India (DCGI) on Wednesday suspended the licence to fabricate and market PresVu, a watch drop that claims to cut back the necessity for studying glasses in folks with Presbyopia – a standard age-related drawback that makes it troublesome to deal with shut objects.
Govt sources mentioned the motion has been taken as a result of the makers of the attention drop, Entod Prescribed drugs, had been concerned in unauthorised promotion of the product which raised doubt on its unsafe use by sufferers and security concern for the general public.”The promotion had raised concern about its use like OTC medication whereas it’s authorised as a prescription solely drug,” govt sources mentioned.
Entod Prescribed drugs, however, denied making any unethical or false presentation of details on the subject of the PresVu eye drops and mentioned it can problem the suspension order within the courtroom of legislation to get justice.
“Our approval by DCGI was based mostly on a legitimate managed scientific trial in 234 sufferers which was profitable in displaying efficacy and security of those eye drops in sufferers of Presbyopia, who used these drops with out eyeglasses and will learn extra traces on Snellen‘s chart which is yardstick of close to imaginative and prescient impairment,” the corporate mentioned in its assertion.
“Such eye drops with the identical energetic ingredient and similar focus have been authorised by the US FDA and marketed within the US for the final three years with none severe issues. FDA did not take any motion on the businesses advertising the identical within the US,” the assertion added.
Govt sources mentioned the motion has been taken as a result of the makers of the attention drop, Entod Prescribed drugs, had been concerned in unauthorised promotion of the product which raised doubt on its unsafe use by sufferers and security concern for the general public.”The promotion had raised concern about its use like OTC medication whereas it’s authorised as a prescription solely drug,” govt sources mentioned.
Entod Prescribed drugs, however, denied making any unethical or false presentation of details on the subject of the PresVu eye drops and mentioned it can problem the suspension order within the courtroom of legislation to get justice.
“Our approval by DCGI was based mostly on a legitimate managed scientific trial in 234 sufferers which was profitable in displaying efficacy and security of those eye drops in sufferers of Presbyopia, who used these drops with out eyeglasses and will learn extra traces on Snellen‘s chart which is yardstick of close to imaginative and prescient impairment,” the corporate mentioned in its assertion.
“Such eye drops with the identical energetic ingredient and similar focus have been authorised by the US FDA and marketed within the US for the final three years with none severe issues. FDA did not take any motion on the businesses advertising the identical within the US,” the assertion added.
