Entod eye drops’ licence junked for misleading claims, overselling

The national drugs regulator has suspended its approval for Mumbai-based Entod Pharmaceuticals to make and sell its “PresVu” eye drops for overselling the product’s claimed benefits, which included reducing a presbyopia patient’s dependency on reading glasses. In an order issued on Tuesday, the Drugs Controller General of India said it issued permission on August 20 to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution, the chemical name of PresVu, to treat presbyopia in adults, permission which it was suspending till further orders. “… considering the public interest, the permission dated 20.08.2024 issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% is hereby suspended till further order under the provisions of rule 84 of the New Drugs and Clinical Trials Rules, 2019, of the Drugs and Cosmetics Act, 1940,” read Drugs Controller General, Rajeev Singh Raghuvanshi’s letter. Among concerns the regulator raised include the company promoting it as the “first eye drop in India designed to reduce the need for reading glasses.” “In this regard you are informed that the pilocarpine hydrocholoride ophthalmic solution has not been approved for any such claim that it is designed to reduce the need for reading glasses.” In response to the claim “this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses”, the company submitted that in the clinical trial conducted, subjects did not wear glasses to participate.