DCGI suspends Entod’s marketing approval for PresVu eye drops amid misuse concerns
The drug had claimed that it will reduce the need for reading glasses for persons suffering from presbyopia
The Drugs Controller General of India (DCGI) has suspended the approval granted to Mumbai-based Entod Pharmaceuticals for manufacturing and sale of its eye drops— PresVu— for aggressively overselling the benefits of the product amid concerns of misuse by masses attempting to buy the prescription drug over-the-counter (OTC).
The drug had claimed that it will reduce the need for reading glasses for persons suffering from presbyopia. In response, the company said that it will challenge the suspension in court.
Entod was aiming at an October launch in the Indian market.
Presbyopia is an eye condition that makes it harder to see objects up close as people age. It is also known as age-related farsightedness.
In an order issued on Tuesday, the drugs regulator said that the directorate had issued permission on August 20 for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults.
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In a letter written to the company on Tuesday, the DCGI said that it was suspending the approval until further order.
“… considering the public interest, the permission dated 20.08.2024 issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% is hereby suspended till further order under the provisions of rule 84 of the New Drugs and Clinical Trials Rules, 2019, of the Drugs and Cosmetics Act, 1940,” read DCGI, Rajeev Singh Raghuvanshi’s letter.
The drugs regulator issued a show-cause notice to the company on September 4 after it found the company over-selling the benefits of the approved eye drop.
Among concerns raised by the regulator include the company promoting it as ‘first eye drop in India designed to reduce the need for reading glasses.
“In this regard you are informed that the pilocarpine hydrocholoride ophthalmic solution has not been approved for any such claim that it is designed to reduce the need for reading glasses”, the regulator said.
In response to the claim “this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses”, the company submitted that in the clinical trial conducted, subjects did not wear glasses to participate.
“In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drop can enhance near vision without the need for reading glasses,” read the order.
In response to the claim, “PresVu can provide an advanced alternative that augments near vision within 15 minutes”, the firm in its response stated that one doctor has evaluated the drug product as compared to reading glasses.
“In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes,” the order read.
The drug regulator stated that the company has failed to respond to the queries and tried to justify the claims for the product for which no approval was granted.
The company, however, stuck to its claims.
Nikkhil K Masurkar, CEO Entod Pharmaceuticals, said in a statement that the company will challenge the suspension in Court as no unethical or false presentation of facts has been made to the media or public.
All facts disclosed were strictly on the basis of the DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by the company in India.
“…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,” read Masurkar’s statement.
“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…,”
“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 the 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”, his statement read.
“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. 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.”