Indian Drug Regulator Withdraws Approval For PresVu Eye Drops
The health ministry said the company's promotion of the eye drops had raised safety concerns for the public.
The Central Drugs Standard Control Organisation has withdrawn the approval granted to PresVu eye drops, manufactured by Entod Pharmaceuticals, over its claim to reduce dependency on reading glasses.
"Taking serious note of the unauthorised promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Entod Pharmaceuticals, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order," the Ministry of Health and Family Welfare said on Wednesday.
"The unauthorised promotion in the press and over social media had raised doubt about its unsafe use by patients and safety concerns for the public," the ministry added.
The promotion had raised concerns about its use like an over-the-counter drug, whereas it was approved as a prescription-only drug, it further noted.
The eye drops were granted approval on Sept. 3 for the treatment of presbyopia in adults.
Drug regulator CDSCO, in an order dated Sept. 10, said it took cognisance of news reports in which Entod Pharmaceuticals claimed that it offers the "first eye drop in India designed to reduce the need for reading glasses." It also took note of the claim that the drug "can provide an advanced alternative that augments near vision within 15 minutes."
The regulator clarified that the eye drops were "not approved for any such claim." CDSCO said that it had also sought a response from Entod Pharmaceuticals over the matter in a notice issued on Sept. 5.
"After a perusal of your reply, it is clear that you had failed to respond to the queries as put to you. You had tried to justify the claims for the product for which no approval was granted," the order stated.
