DCGI suspends nod for Entod’s eye drop, company says will challenge the order

The Drug Controller General of India (DCGI) has suspended, until further orders, the permission granted to Entod Pharmaceuticals to make and sell their new eye drop, which claimed to reduce dependency on reading glasses for those suffering from presbyopia.
The DCGI order, reviewed by Moneycontrol, said the company did not obtain approval from the Central Licencing Authority to make such claims for the product. The order said that it has held the pharma company in violation of the permission to manufacture the ophthalmic solution under the New Drugs and Clinical Trial Rules, 2019.
“After pursual of your reply, it is clear that you had failed to respond to the queries as put to you,” said the order.
Entod Says Disclosed All Facts
The company has denied any unethical representation, and Nikkhil Masurkar, Entod’s CEO has said that they will challenge the suspension in the court of law.
“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.”
Presbyopia is an age-related vision condition that typically affects those above 40, causing difficulty in focusing on close objects.
Entod Pharma said that the suspension order from DCGI ‘made no reference’ to any specific violation. “In our case, media reports went viral and public imagination led to an unusual escalation for which Entod Pharmaceuticals is not responsible,” the company added.
DCGI On Entod’s Claims
DCGI had issued permission to Entod in August to manufacture and market its treatment for presbyopia, and subsequently issued a notice to the company on September 5 with regards to the claims made by the company.
One of the claims by Entod was that the eyedrop was designed to reduce the need for reading glasses. The DCGI order has denied giving any approval for this claim. The order said, “Considering the various media reports, there is a likelihood of the general public being misled by claims made by you, for which no approval was granted.”
The company’s submission to DCGI said that during the clinical trials of the ophthalmic solution, the subjects did not wear glasses to participate.
The Drug Controller also questioned one of the claims by Entod, which said the eye drop offered a non-invasive option to enhance near vision, stating that the approval was not given for any claim that the eye drop could achieve this result without the need for reading glasses.
“You had tried to justify the claims for the product for which no approval was granted,” said the order.
Source: Moneycontrol