Regulator CDSCO suspends Entod Pharmaceuticals nod to make, sell eye drops

Action taken over company's claim that the eye drop use will replace reading glasses

The Central Drug Standards Control Organisation (CDSCO) 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 (OTC) 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, chief executive officer (CEO), Entod Pharma announced that the company will challenge the suspension in court of law 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. 

Entod had received approval by DCGI last week. “Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of presbyopia”, the company 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 said 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.