The DCGI said the company made claims for the product for which it had not obtained approval
Taking serious note of Mumbai-based Entod Pharmaceuticals' claims that it can help reduce dependency on reading glasses for those suffering from presbyopia, the Drugs Controller General of India (DGCI) has suspended permission given to the company to manufacture and sell their new eye drop, PresVU.
According to the National Eye Institute, presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close.
The DCGI said the company made claims for the product for which it had not obtained approval from the Central Licensing Authority, violating provisions under the New Drugs and Clinical Trial Rules, 2019.
The DCGI on Tuesday said it gave permission on August 20 for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults. On September 4, the drug regulator had asked for an explanation from the company for the claims it made in the press following which the pharma firm gave its response.
The company had claimed it was the "first eye drop in India designed to reduce the need for reading glasses".
"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses," the DCGI order said.
In response, the company said, "This eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses."
The DCGI order said considering the media reports, there is a likelihood of the general public being misled by the claims made by the company for which no approval was granted.
While the eyedrop was approved for the treatment of presbyopia in adults, it was not approved for near vision within 15 minutes without the need for reading glasses.
The drug's approval from the regulator was only as a prescription drug, and not as an over-the-counter drug, which it was being wrongly promoted.