Regulator revokes approval after Pharma firm’s bold eye drop claims
PTC News Desk: The Drugs Controller General of India (DCGI) has suspended Mumbai-based Entod Pharmaceuticals’ permission to manufacture and sell their new eye drop, PresVU, following claims that the product could reduce dependency on reading glasses for those suffering from presbyopia. Presbyopia is a refractive error common in middle-aged and older adults, making it difficult to focus on close objects.
The DCGI stated that Entod Pharmaceuticals had not obtained the necessary approval from the Central Licensing Authority to make such claims, which violated the provisions under the New Drugs and Clinical Trial Rules, 2019.
The drug regulator had originally granted approval on August 20 for the manufacturing and marketing of Pilocarpine Hydrochloride Ophthalmic Solution, designed for treating presbyopia in adults. However, after media reports surfaced claiming that the eye drop could reduce the need for reading glasses, the DCGI sought an explanation from the company on September 4. Entod Pharmaceuticals responded to the inquiry, but the regulator found the claims misleading.
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The company had promoted PresVU as “the first eye drop in India designed to reduce the need for reading glasses,” but the DCGI clarified that Pilocarpine Hydrochloride Ophthalmic Solution (1.25% w/v) had not been approved for any such claims.
In response to the regulator’s action, Entod Pharmaceuticals stated that the eye drop provides a “non-invasive option that can enhance near vision without the need for reading glasses.” However, the DCGI pointed out that the product had only been approved for presbyopia treatment and not for improving near vision within 15 minutes, as claimed.
Moreover, the eye drop had been approved strictly as a prescription drug, but it was being incorrectly promoted as an over-the-counter solution, adding to the regulator’s concerns about the potential for misleading the public.
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