New Delhi: India’s drug regulator has suspended Entod Pharmaceutical Ltd.’s authorization to manufacture and market a specific eye drop product, citing the company’s unapproved promotional claims. The Drugs Controller General of India (DCGI) issued the suspension order on September 10, addressing concerns that the eye drops were marketed as reducing the need for reading glasses for people with presbyopia, a claim not approved in India.
The suspension follows the company’s promotion of PresVu—pilocarpine hydrochloride ophthalmic solution USP 1.25%—as the “first eye drop in India designed to reduce dependency on reading glasses” for presbyopia. The eye drops were initially approved for treating presbyopia but not for making such claims, leading the regulator to question the safety of the product and its over-the-counter use.
Entod Pharmaceuticals CEO Nikkhil Masurkar has stated that the company has not made any unethical or false claims about PresVu and plans to contest the order in court.
The DCGI had granted approval for PresVu on August 20 for treating presbyopia in adults. However, concerns arose when the company’s promotional material, released on September 3, suggested that the eye drops could replace reading glasses, a claim not sanctioned by the DCGI.
The regulator’s notice, issued the day after the promotional claims, raised several issues
Claim 1: The “first eye drops in India designed to reduce the need for reading glasses.”
Company Response: No other eye drops are approved for presbyopia treatment in India.
Claim 2: “A non-invasive option enhancing near vision without reading glasses.”
Company Response: Clinical trials did not use glasses during participation.
Claim 3: The eye drops provide an advanced alternative that improves near vision within 15 minutes.
Company Response: Clinical trials compared the product with reading glasses.
The DCGI concluded that the eye drops were only approved for treating presbyopia and not for enhancing near vision without glasses. The regulator noted that Entod Pharmaceuticals had not obtained prior approval for the promotional claims and had violated the conditions of the New Drugs and Clinical Trials Rules, 2019, as well as the Drugs and Cosmetics Act, 1940. The suspension was based on concerns that the unapproved claims could mislead the public.
In response, Masurkar argued that the DCGI had not specified any violations of the Drugs and Cosmetics Act and pledged to challenge the suspension in court. He emphasized that the clinical trials for PresVu, involving 234 patients, demonstrated its efficacy and safety. Masurkar also pointed out that similar eye drops approved by the US FDA have been marketed in the US for the past three years without issues.
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