Taking exception to Mumbai-based Entod Pharmaceuticals’ claims that its new eye drop can help reduce dependency on reading glasses for those suffering from presbyopia, the age-old related eye disorder, the country’s apex drug regulator, Drug Controller General of India (DCGI) has suspended the permission granted to it to manufacture and sell their product.

In its order, the DCGI said that the claims are in violation of the Drugs and Magic Remedies (DMR) Act and were made without prior approval from the Central Licensing Authority. The DMR Act restricts advertisements that suggest a drug can diagnose, cure, or treat listed conditions, including optical disorders.

It also said that it has held the pharma company in violation of the permission to manufacture the ophthalmic solution under the New Drugs and Clinical Trial Rules, 2019.

In an order issued on September 10, the 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.

“…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 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.