Taking serious note of Mumbai-based Entod Pharmaceuticals' claims that it can help reduce dependency on reading glasses for those suffering from presbyopia, the DCGI has suspended the permission granted to it to manufacture and sell their new eye drops.
Entod Pharmaceuticals CEO Nikkhil K Masurkar, however, said the company will challenge the suspension in the court of law.
According to the National Eye Institute, presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close.
The drug regulator said the company made claims for the drug product for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.
In an order issued on September 10, the Drugs Controller General of India (DCGI) said the Directorate had issued permission on August 20 for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults.
Then on September 4, the drug regulator had asked for an explanation from the company for the claims it made in the press following which the drug-maker also submitted its response.
In response to the claim "first eye drop in India designed to reduce the need for reading glasses", the order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India.
"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses," the order 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," the order said.
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.
"...whereas it is clear that you have not obtained any prior approval from the Central Licensing Authority to make such claims for the said drug product as mentioned above. Thus, you have violated the condition No. (vi) of the permission dated 20.08 2024 issued to you for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v under the provisions of the New Drugs and Clinical Trials Rules, 2019.
The order further said considering the various media reports, there is a likelihood of the general public being misled by the claims made by the company for which no approval was granted.
"In view of above and considering the public interest, the permission issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v vide is hereby suspended till further orders under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940," the order stated.
In a statement, ENTOD CEO Masurkar said the company will challenge the suspension in the court of law.
"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," he said.
He said ENTOD has received suspension order with no reference to any specific violation of Drugs and Cosmetics Act for this action.
"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," he said.
"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," Masurkar further said.
