DGCI suspends approval for eye drop firm claimed reduced dependence on reading glasses

You must have heard about the launch of a new eye drop in the market that claimed to reduce dependency on reading glasses. The Drug Controller General of India (DCGI) has now suspended the permission to make and sell the eye drop, which was earlier awarded to Entod Pharmaceuticals.

The DGCI mentioned that the companymade claims for the drug for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.

In response to the claim of being the "first eye drop in India to reduce the need for reading glasses", the DGCI order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India.

"After perusal of your reply, it is clear that you had failed to respond to the queries as put to you," the DGCI order said.

Considering various 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, it added.

"In view of the above and considering the public interest, the permission issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v vide is hereby suspended till further orders under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940," the order stated.

Entod Pharmaceuticals to go to court

The company in its statement denied any unethical representation and vowed to take the DGCI to court over the suspension order.

"We at Entod Pharmaceuticals hereby declare that we have not made any unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops. All facts disclosed to the media were strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India," the company said.

Claims made by the company

Earlier, the company claimed its Presvu Eye Drops help people overcome presbyopia, a vision-related condition that usually arises above 40. Presbyopia makes it difficult for the patient to focus on close objects.

DGCI had earlier issued a notice to the company on Sep 5 in connection with these claims.

It also clarified that the permission to make this claim publicly was never given to the company.

The regulator also questioned the claim that the eye drop offered a non-invasive option to enhance near vision.

"You had tried to justify the claims for the product for which no approval was granted," the DGCI said.

(With inputs from agencies)