DCGI Suspends ENTOD Pharmaceuticals' Eye Drops for Unauthorized Promotion

The Drugs Controller General of India (DCGI) has suspended ENTOD Pharmaceuticals' product PresVu due to its unauthorized promotion. The company denied any false representation, but regulators and medical experts raised safety concerns. PresVu, which treats presbyopia, is viewed skeptically by some ophthalmologists.

The Drugs Controller General of India (DCGI) has suspended ENTOD Pharmaceuticals' product PresVu after the company failed to respond to queries about the product, which lacked proper approval.

In an official statement, the Union Ministry of Health and Family Welfare highlighted the unauthorized promotion of PresVu, raising concerns over its safety and its presentation as an over-the-counter (OTC) drug. ENTOD Pharmaceuticals denied any unethical practices, stating that their communications were based on approved indications and clinical trial data.

Despite the company's defense, medical experts have questioned the efficacy and safety of PresVu, which is primarily composed of pilocarpine, a drug used for glaucoma treatment. They caution that although PresVu offers a temporary solution for presbyopia, it has potential complications.