Days after Entod Pharmaceuticals’ claim that its eye drop can reduce dependency on reading glass, the Drug Controller General of India (DCGI) has suspended the permission granted to Entod Pharmaceuticals to make and sell the product.
In an order, issued on 10 September, the DCGI said the company did not obtain approval from the Central Licencing Authority to make such claims for the product. It also stated 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.
“Taking serious note of the unauthorized promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Etod Pharmaceuticals Ltd, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order,” the DCGI stated, as reviewed by Financial Express.com.
“The unauthorized 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 raise concern about its use like OTC drugs whereas it is approved as a prescription only drug,” it further added.
On September 3, the pharmaceutical company conducted a press conference to announced that it has received final approval from the Drug Controller General of India (DCGI) for its PresVu eye drops.
During the press conference, the company leadership announced that this approval follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Following the announcement, experts and health officials claimed that the company is presenting wrong facts. 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.
“After pursual of your reply, it is clear that you had failed to respond to the queries as put to you,” said the order.
Presbyopia is an age-related vision condition that typically affects those above 40 and it causes difficulty in focusing on close objects.
The company had claimed that the eyedrop was designed to reduce the need for reading glasses. However, 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.”
Moreover, 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 company also claimed that the eye drops offered a non-invasive option to enhance near vision. The DCGI questioned this claim and said 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.
Financial Express.com reached out Nikkhil K Masurkar, CEO, Entod Pharmaceuticals following the development and he said that 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.
“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,” Masurkar told Financial Express.com.
Announcing the new product launch to the media is a routine industry practice followed by all pharma companies in India and in the recent past, many such announcements have been made, he said.
“In our case, media reports went viral and public imagination led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible. 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, who used these drops without eye glasses and could read additional lines on Snellen’s chart which is a yardstick of near vision improvement. Such eye drops with same active ingredient and same concentration has been approved by the US FDA and marketed in the US for last 3 years without any serious complications. FDA didn’t take any action on the companies marketing the same in USA,” he said in a statement shared over WhatsApp.
However, Entod Pharmaceuticals has received a suspension order from the DCGI who has made no reference to any specific violation of Drugs and Cosmetics Act for this action, he informed.
“The logic applied here is the contents of our press release which has described the application of this new drug for the benefit of the lay press in more verbose terms than the exact wording of the approved indication which is – Treatment of Presbyopia. If you examine many such press announcement of other big pharma companies which are present on their website, you will always find additional descriptions about the product and condition beyond the exact approved indication,” he said.
“We strongly desist this action against a proud Indian pharma company in the MSME sector company like Entod Pharmaceuticals which is purely research and innovation driven and attempts to bring new therapeutic options to the Indian market. As a result, we have decided to challenge this suspension in the court of law to get justice. Our fight will not only allow innovative medicines to be available in India but also encourage other pharmaceutical entrepreneurs and companies in the MSME sector to continue the research drive in India without facing similar obstacles,” the CEO added.
