Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims

The DCGI has halted the authorization given to Mumbai-based Entod Pharmaceuticals to produce and market its novel eye drops, citing the company's assertions that it can assist individuals with presbyopia in becoming less reliant on reading glasses. However, Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, stated that the business would contest the suspension in court.

Presbyopia is a refractive error that affects middle-aged and older people's ability to see up close, according to the National Eye Institute.

According to the drug authority, the company violated the New Drugs and Clinical Trial Rules, 2019 by making claims for the drug product for which it did not have Central Licensing Authority permission.

The Drugs Controller General of India (DCGI) stated in an order dated September 10 that the Directorate had approved on August 20 for the production and distribution of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of adult presbyopia.

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 that "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. 

"...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 the 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.

"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 a suspension order with no reference to any specific violation of the 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.

(With PTI Inputs)

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