Mumbai-based Entod Pharmaceuticals said on Thursday that it has decided to move the court to challenge the national drug regulator’s suspension of permission to manufacture and market its pilocarpine hydrochloride ophthalmic solution formulation, branded as PresVu.
The company denied the regulatory authority’s allegation that it has engaged in unauthorised promotion of the product through media.
Nikkhil K Masurkar, CEO of the pharma firm, in a press statement said that this action is against a pharma company in the MSME sector, 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,†said Masurkar.
“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,†he said.
The company also said that it has 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 approval by the Drugs Controller General (India) for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India.
“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. In our case, media reports went viral and public imagination led to an unusual escalation for which Entod Pharmaceuticals is not responsible,†he said.
The 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.
