CDSCO says no to Entod's No Chashma eye drops

September 12, 2024 08:37

Sanket Koul/Business Standard

The Central Drug Standards Control Organisation on Wednesday suspended permission granted to Mumbai-based Entod Pharmaceuticals to manufacture and sell an eye drop after taking exception to the firm's claim that it can help eliminate dependency on reading glasses for those suffering from presbyopia.

According to sources, health ministry officials took this matter seriously due to concerns over misuse of the product.

Last week, Entod launched its PresVu eye drop made using Pilocarpine, an alkaloid used to treat various ophthalmological conditions including presbyopia. Presbyopia is an age-related sight condition that makes it difficult to see things up close.

In his order dated September 10, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said that the company had made claims for the drug product for which it had not obtained approval from the central licensing authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.

"The unauthorised promotion in press and over social media had raised doubt on its unsafe use by patients and safety concern for the public. The promotion had raised concern about its use like over the counter drugs whereas it is approved as a prescription only drug," an official source said.

Denying charges of unethical or false presentation of facts, Nikkhil Masurkar, CEO, Entod Pharma, announced that the company will challenge the suspension in court to get justice.

'All facts disclosed to the media are 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 added.

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