The Drugs Controller General of India (DCGI) has suspended its approval for Entod Pharmaceuticals’ yet-to-be-launched eye drops, for reasons including unauthorised promotion and concern that the by-prescription product would be used like an over-the-counter drug.
The approval is for the manufacture and marketing of Pilocarpine Hydrochloride Opthalmic Solution USP 1.25 per cent, for the treatment of Presbyopia in adults, the DCGI order said.
Outlining claims made by the company, the regulator said the product had not been approved for the claim that it was “designed to reduce the need for reading glasses”. On the drops being “a non-invasive option that can enhance near vision without the need of glasses”, the DCGI said, it had not approved such a claim. The regulator said it had not approved a claim indicating that the product provided an advanced alternative that augments vision in 15 minutes. Further, it added, the company had not obtained approval from the Central Licensing Authority to make the above outlined claims.
Entod’s PresVu eye drops had been slated for launch in October, its representatives had told businessline.
Likely to challenge
Responding to the DCGI’s order, Nikkhil K Masurkar, Entod’s Chief Executive, said in a statement that they had not made an “unethical or false presentation of facts” on their 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,” he said, adding that they had “decided to challenge this suspension in the court of law to get justice.”
Addressing interest in its eye drops, 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 the US.”
The company said the DCGI’s order “made no reference to any specific violation of Drugs and Cosmetics Act for this action. 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.”
The company intends to challenge the suspension, the note said adding, “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.”