The Directorate General of Health Services (DGHS), under the Central Drugs Standard Control Organisation (CDSCO), has suspended the manufacturing and marketing licence for ENTOD Pharmaceuticals Ltd’s Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%, marketed as PresVu. This decision comes in response to allegations of misleading marketing claims regarding the treatment of presbyopia, an age-related vision issue.
On August 20, 2024, ENTOD Pharmaceuticals received approval to produce and market PresVu for managing presbyopia in adults. However, a notice issued on September 4, 2024, revealed that the company had made several unapproved claims in its media releases.
The DGHS pinpointed three specific instances where ENTOD allegedly exaggerated the product's benefits, including claims that the eye drops could reduce the need for reading glasses and improve near vision within 15 minutes. The regulator stated that these claims were not authorized and could potentially mislead consumers.
In defense, ENTOD Pharmaceuticals argued that the claims were based on clinical trials and aligned with industry practices. Nikhil K Masurkar, CEO of ENTOD Pharmaceuticals, said, “All facts disclosed to the media are strictly on the basis of recent DCGI approval and clinical trials.” He also pointed out that similar formulations have been marketed in the United States without regulatory issues.
Despite the company's defense, the DGHS suspended the product's licence under the Drugs and Cosmetics Act, 1940, citing public interest concerns. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), stated, "The permission issued on 20.08.2024 is hereby suspended until further order."
ENTOD Pharmaceuticals plans to challenge the suspension in court, asserting that the decision impedes innovation in the Indian pharmaceutical sector. Masurkar added, “This fight will not only allow innovative medicines in India but also encourage other MSME pharmaceutical companies to continue their research.”
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