Mumbai-based drugmaker Entode Pharmaceuticals has denied making any “ethical” claims or “misrepresentation of facts” about its new Presvu eye drops.

After the company launched its eye drops, which claimed that the product could eliminate the need for reading glasses for people suffering from presbyopia, the Drugs Controller General of India (DCGI) suspended the permission given to the company to manufacture and sell its new product.

The drug regulator said the company made claims about Presvu eye drops without approval from the central licensing authority, which is in violation of the New Drugs and Clinical Trials Rules, 2019.

In response, Nikhil K. Masurkar, CEO of Entode Pharmaceuticals, said that all the facts disclosed to the media were “solely based on the DCGI approval, specifically the results of the Phase 3 clinical trial we conducted in India.”

“Announcing new product launches before the media is a routine industry practice followed by all pharma companies in India and several such announcements have been made in recent times. In our case, the media reports went viral and caused abnormal aggravation of public imagination, for which Entod Pharmaceuticals is not responsible,” he said.

The company said that they are taking legal recourse in this matter.

Masurkar said, “We strongly oppose this action against Entod Pharmaceuticals, a proud Indian pharma company from the MSME sector, which is completely driven by research and innovation and strives to bring new therapeutic options to the Indian market. As a result, we have decided to challenge this suspension in court to seek justice.”

In an order dated September 10, the DCGI had permitted the manufacture and sale of Pilocarpine Hydrochloride Ophthalmic Solution (Pressvu Eye Drops). But later on September 4, the drug regulator sought clarification from the company for the claims made in the press.

Entode Pharmaceuticals said the approval by the DCGI was based on a “validated controlled clinical trial on 234 patients” which succeeded in showing the efficacy and safety of these eye drops in patients with presbyopia who used these drops without glasses and could read the additional lines on the Snellen chart, a measure of near vision correction.

Presvu eye drops contain a medicine called 1.25% pilocarpine, which is proven to temporarily improve near vision for people with presbyopia. Presbyopia is an age-related condition where the lens of the eye gradually loses its ability to focus on nearby objects.

Pilocarpine is a US FDA-approved medication used for presbyopia in adults.

The drug regulator told the company that the eye drops “have not been approved for any claim that they are designed to reduce the need for reading glasses.”

The DCGI said the company failed to answer queries and attempted to justify claims for a product for which no approval had been granted.

The order further stated that considering various media reports, the claims made by the company are likely to mislead the general public.

The company is now going to challenge this suspension in court.

Masurkar said, “Our fight will not only make innovative medicines available in India but will also encourage other pharmaceutical entrepreneurs and companies in the MSME sector to continue research drives in India without facing the same hurdles.”