The Drugs Controller General of India (DCGI) has suspended the approval granted to Entod Pharmaceuticals’ PresVu (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) eye drops over alleged misleading claims of treating presbyopia, an age-related vision issue, farsightedness) and reducing dependency on reading glasses. The company will move court against the suspension order.
In an order, DCGI said it was suspending till further orders permission issued on August 20 to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution, the chemical name of PresVu, to treat presbyopia in adults.
“… 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,” the order said and issued a show-cause notice to the company.
“In this regard you are informed that the pilocarpine hydrochloride ophthalmic solution has not been approved for any such claim that it is designed to reduce the need for reading glasses,” the order said.
Entod Pharmaceuticals CEO Nikkhil K Masurkar denied making unethical claims.
“Entod Pharmaceuticals has received a suspension order from the DCGI who has made no reference to any specific violation of Drugs and Cosmetics Act for this action. The logic applied here is the contents of our press release which has described the application of this new drug for the benefit of the lay press in more verbose terms than the exact wording of the approved indication which is – Treatment of Presbyopia,” it said.
