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Entod eye drops’ licence junked for misleading claims, overselling
The company, which was aiming for an October launch in the Indian market, said that it will challenge the suspension in court.
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 (age-related farsightedness) patient’s dependency on reading glasses.
The company, which was aiming for an October launch in the Indian market, said that it will challenge the suspension in court.
Presbyopia is an eye condition that makes it harder to see objects up close as people age.
In an order issued on Tuesday, the Drugs Controller General of India (DCGI) 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.
The drugs regulator issued a show-cause notice to the company on September 4 after it found the company over-selling the benefits of the approved eye drop and making it sound as if the drug was available over-the-counter.
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.
The company, however, stood by its claims.
Entod Pharmaceuticals CEO Nikkhil K Masurkar said in a statement the company made no unethical claims or misrepresentative 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.
