“Considering the public interest the permission issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic solution 1.25% is hereby suspended till further orders,” the DCGI order said. ET has reviewed a copy of the order. Entod Pharmaceuticals’ chief executive officer, Nikkhil K Masurkar, said the company will challenge the suspension in court.
He said the company has not made any unethical or false presentation of facts to the media or the public regarding PresVu.
“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,” he said in a statement.
Masurkar said the approval granted to the company was based on a valid controlled clinical trial involving 234 patients which was successful in showing the efficacy and safety of the eye drops in patients of presbyopia, who used these drops without eye glasses and could read additional lines on Snellen’s chart.
The DCGI, on the other hand, 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 regulator’s order.The DCGI had earlier granted permission to Entod to manufacture and market its treatment for presbyopia, and subsequently, on September 5, issued a notice to company over claims made by the company. Entod claimed that the new eye drop offers a non-invasive option that can enhance near vision without need for reading glasses. It was designed to reduce need for reading glasses, it said.
The DCGI order said that Pilocarpine Hydrochloride Ophthalmic solution 1.25% is not approved for such a claim.
“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 order said.
The DCGI said that after perusal of the company’s reply, it was clear that it failed to respond to the queries as put to it. “You had tried to justify the claims for the product for which no approval was granted,” the order said.
According to Masurkar, launching a new product is a routine industry practice followed by all pharma companies in India and in the recent past, many such announcements have been made.
“In our case, media reports went viral and public imagination led to an unusual escalation for which Entod is not responsible,” he said.
Masurkar said that eye drops with the same active ingredient and same concentration have been approved by the USFDA and marketed in the US for the last three years without any serious complications.
