New Delhi [India], September 11 (ANI): Entod Pharmaceuticals' Chief Executive Officer (CEO) Nikkhil K Masurkar said that the company will challenge the Drugs Controller General of India's (DCGI) order suspending manufacturing and marketing licenses for their PresVu eye drops.
The drug regulator suspended permission, citing the company's failure to respond to the queries on the product for which the DCGI says "no approval was granted."
"We have decided to challenge this suspension in the court of law to get justice.Entod Pharmaceuticals received the suspension order from the DCGI, who has made no reference to any specific violence of the Drugs and Cosmetics Act for this action," Entod Pharmaceuticals CEO Masurkar said.
In a statement, the Union Ministry of Health and Family Welfare earlier mentioned, "Taking serious note of the unauthorised promotion of the product, PresVu (1.25 per cent Pilocarpine w/v) by Entod Pharmaceuticals Ltd., after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order."
The statement further mentioned that the unauthorised promotion in the press and over social media had raised doubts about its unsafe use by patients and safety concerns for the public. The promotion raised concern about its use like OTC drugs, whereas it is approved as a prescription-only drug, it added.
However, ENTOD Pharmaceuticals denied making any unethical or false presentation of facts to the media or public on PresVu eye drops.
"We at ENTOD Pharmaceuticals hereby declare that we have not made any of the unethical or false presentation of facts to the media or public when it comes to Presvu Eye drops. All facts disclosed to the media are strictly on the basis of the approved indication for treatment of presbyopia in adults and the phase 3 clinical trial data generated by us," Entod Pharmaceuticals CEO Nikkhil K Masurkar said in a statement earlier.
The company further mentioned that the opinions and claims printed in news reports do not represent ENTOD Pharmaceuticals. "Some of the opinions and claims printed in news stories do not represent that of ENTOD Pharmaceuticals or any of its spokespeople. The widespread media interest in such a therapy has been unprecedented and has led to sensationalization of the story," the statement mentioned.
Sources from drug regulatory to ANI said that claims made by the company are unethical and a false presentation of facts. The company had been asked for an explanation for the false representation by the drug regulator.
As per the source, the company during the launch claimed, "PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40. Presvu has also been applied for a patent for this invention in terms of its formulation and the process. The proprietary formula not only gets rid of reading glasses but also helps the patient lubricate their eyes as a side benefit."
"PresVu is the result of years of dedicated research and development. This DCGI approval is a major step forward in our mission to transform eye care in India. PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence. We take pride in our commitment to innovation and in providing healthcare solutions that are both accessible and affordable," said Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals. However, medical experts termed it an "imperfect and temporary solution." (ANI)
