The Central Drug Standards Control Organisation (CDSCO) on Wednesday suspended permission granted to Mumbai-based Entod Pharmaceuticals to manufacture and sell their new eye drops, taking serious note of the drugmaker’s claims 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 (OTC) drugs whereas it is approved as a prescription-only drug,” an official source said.
The company’s claims included that the PresVu eye drop was the first in India designed to reduce the need for reading glasses, offering a non-invasive option to enhance near vision within 15 minutes.
In response to these claims, the DCGI order stated that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v or PresVu had not been approved for any such claims that it is designed to reduce the need for reading glasses.
The apex drug body had then issued a notice to the company on September 4, asking it to provide clarifications over the claims made by it.
Evaluating the responses from the firm, the drug regulatory body concluded that “after a perusal of your reply, it is clear that you had failed to respond to the queries as put to you. You had tried to justify the claims for the product for which no approval was granted.”
First Published: Sep 11 2024 | 6:24 PM IST
