Entod Pharmaceuticals' PresVU Eye Drop Under Scrutiny by Drugs Controller General of India

Entod Pharmaceuticals' Eye Drop Controversy

The Drugs Controller General of India (DCGI) has revoked the approval of PresVU, an eye drop developed by Entod Pharmaceuticals. The DCGI raised concerns after the company claimed that PresVU could significantly reduce the reliance on reading glasses for individuals experiencing presbyopia.

Regulatory Findings

Entod failed to secure necessary approval from the Central Licensing Authority before making such claims, which violate the New Drugs and Clinical Trial Rules, 2019. The DCGI originally approved the manufacturing of Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia on August 20. However, after reports emerged about PresVU’s claims, the regulator demanded clarification from Entod on September 4. The claims made by the company were ultimately deemed misleading and unsupported.

Response from Entod

In response to the regulatory suspension, Entod Pharmaceuticals maintained that PresVU serves as a non-invasive treatment alternative to enhance near vision without needing reading glasses. The DCGI's investigation, however, confirmed that the eye drop was only approved for presbyopia treatment and not to improve near vision within a brief timeframe, counter to the company’s promotions.

Additionally, the eye drop was designated strictly as a prescription drug but had been incorrectly marketed as an over-the-counter medication, prompting further concerns about public misinformation.

Further Developments and Implications

This incident underscores the critical need for pharmaceutical companies to adhere to regulatory guidelines to ensure public safety. The DCGI's proactive approach to regulating misleading health claims is essential in maintaining trust in medical innovations like PresVU.