NEW DELHI: The Drug Controller General of India (DCGI) on Wednesday suspended the licence to manufacture and market PresVu, an eye drop that claims to reduce the need for reading glasses in people with Presbyopia – a common age-related problem that makes it difficult to focus on close objects.
Govt sources said the action has been taken because the makers of the eye drop, Entod Pharmaceuticals, were involved in unauthorised promotion of the product which raised doubt on its unsafe use by patients and safety concern for the public.”The promotion had raised concern about its use like OTC drugs whereas it is approved as a prescription only drug,” govt sources said.
Entod Pharmaceuticals, on the other hand, denied making any unethical or false presentation of facts with regards to the PresVu eye drops and said it will challenge the suspension order in the court of law to get justice.
“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen‘s chart which is yardstick of near vision impairment,” the company said in its statement.
“Such eye drops with the same active ingredient and same concentration have been approved by the US FDA and marketed in the US for the last three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the US,” the statement added.
Govt sources said the action has been taken because the makers of the eye drop, Entod Pharmaceuticals, were involved in unauthorised promotion of the product which raised doubt on its unsafe use by patients and safety concern for the public.”The promotion had raised concern about its use like OTC drugs whereas it is approved as a prescription only drug,” govt sources said.
Entod Pharmaceuticals, on the other hand, denied making any unethical or false presentation of facts with regards to the PresVu eye drops and said it will challenge the suspension order in the court of law to get justice.
“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen‘s chart which is yardstick of near vision impairment,” the company said in its statement.
“Such eye drops with the same active ingredient and same concentration have been approved by the US FDA and marketed in the US for the last three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the US,” the statement added.