DCGI Suspends Entod Pharma’s Eye Drops Amid False Claims Regarding Eye Issues
Background of the Suspension
The Drug Controller General of India (DCGI) has halted the authorization given to Mumbai-based Entod Pharmaceuticals to produce and market its novel eye drops. This suspension arose due to the company's assertions that its product could assist individuals with presbyopia in becoming less reliant on reading glasses.
Details of the Drug Regulation
According to DCGI, Entod Pharma has violated the New Drugs and Clinical Trial Rules, 2019 by making claims for which it did not have the necessary permissions from the Central Licensing Authority. The DCGI highlighted that Entod’s approval for the production and distribution of Pilocarpine Hydrochloride Ophthalmic Solution was granted on August 20 for adult presbyopia treatment.
Response from Entod Pharmaceuticals
Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, stated that the company would contest the suspension in court. The discussion surrounding the claims made by the company has intensified since the DCGI requested an explanation on September 4, following which Entod submitted its response.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.