In response to Entod Pharmaceuticals’ claims that its new eye drops could reduce reliance on reading glasses for those with presbyopia, the Drugs Controller General of India (DCGI) has suspended the company’s authorization to manufacture and sell the product.
Presbyopia is a common age-related vision condition that makes it difficult for middle-aged and older adults to see objects up close.
The DCGI’s decision came after it was revealed that the company had promoted the eye drops without obtaining the necessary approvals from the Central Licensing Authority, in violation of the New Drugs and Clinical Trial Rules, 2019.
On September 10, the DCGI issued an order noting that permission for the Pilocarpine Hydrochloride Ophthalmic Solution, intended to treat presbyopia, was initially granted on August 20. However, on September 4, the regulator requested an explanation from Entod Pharmaceuticals regarding its promotional claims.
The company had advertised the eye drops as the “first in India to reduce the need for reading glasses” and suggested they offer a non-invasive solution to enhance near vision without glasses. The DCGI order clarified that such claims were not approved for the product. The Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is approved only for treating presbyopia and not for claims of significantly improving near vision or replacing reading glasses.
The order also stated that the company did not adequately address the DCGI’s queries and continued to promote the product with unapproved claims.
Given the potential for public misinformation and the lack of approval for the promotional statements, the DCGI has suspended the manufacturing and marketing permission for the eye drops until further notice, in accordance with Rule 84 of the New Drugs and Clinical Trials Rules, 2019.
