Lagatar24 Desk
New Delhi: The Drug Controller General of India (DCGI) has withdrawn approval for Mumbai-based Entod Pharmaceuticals’ eye drop, PresVU, following unverified claims made by the company regarding its efficacy. The eye drop was promoted as reducing the need for reading glasses among patients suffering from presbyopia, a claim for which the company had not obtained the required approval.
Presbyopia is a common refractive error that typically affects middle-aged and older adults, making it difficult to see objects up close. Entod Pharmaceuticals had claimed that their eye drop could help presbyopia patients reduce dependence on reading glasses—an assertion that led to swift action from the regulatory body.
DCGI’s Response and Suspension
On Tuesday, the DCGI revealed that it had initially granted approval on August 20 for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia in adults. However, the company’s subsequent claims regarding the eye drop’s ability to eliminate the need for reading glasses had not been authorized.
The drug regulator noted that these claims, made in press releases, violated the New Drugs and Clinical Trial Rules, 2019, since no such approval had been given for this particular use of the eye drop. On September 4, the DCGI had sought an explanation from Entod Pharmaceuticals, which the company provided in response.
In its defense, Entod stated that PresVU offers a “non-invasive option that can enhance near vision without the need for reading glasses.” However, the DCGI clarified in its order that while the eye drop had been approved for the treatment of presbyopia, it was not approved for claims related to improving near vision within 15 minutes or reducing dependence on reading glasses.
Potential Misleading of the Public
The DCGI expressed concerns that the claims made by Entod Pharmaceuticals could mislead the public, especially given the wide media coverage of the company’s assertions. The eye drop had also been marketed as an over-the-counter product, which further violated the terms of its prescription-only approval.
Considering these discrepancies, the DCGI decided to suspend the company’s permission to manufacture and sell the eye drop until further notice.
This regulatory action underscores the importance of strict adherence to approved claims in drug marketing, ensuring that the public is not misled by unsupported or exaggerated health benefits.
