In a follow-up to the suspension of the licence of Mumbai-based pharmaceutical company ENTOD Pharmaceuticals by the Drugs Control General of India (DCGI) last month, preventing it from manufacturing and marketing its eye drops, “PresVu”, the drug regulator has now directed the Food and Drugs Control Administration of Gujarat to take “appropriate action” against the company as per the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

The DCGI issued the directive to FDCA Gujarat, following a complaint filed before it by K.V. Babu, a public health activist and an ophthalmologist himself, last month.

Entod Pharmaceuticals, which had launched the prescription eye drops, named PresVu, claiming it to be a “proud Indian innovation”, for the treatment of Presbyopia or difficulty in near vision, had been in the eye of a storm last month when it was pulled up by the apex drug regulator for making overreaching claims .

On September 4, Entod Pharmaceuticals tweeted, tagging Prime Minister Narendra Modi, that “PresVu was the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses”

Dr. Babu had written to the DCGI that Entod Pharmaceuticals, by tweeting about the drug (which is a prescription drug), had committed a gross violation of Section 3(d) of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

Section 3(d) of the said Act says that none shall publish any advertisement referring to the use of a drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule. There are 54 diseases/disorders/conditions, specified in the said Schedule and no. 11 in the list is “Diseases and disorders of the optical system”. Presbyopia is a disorder of the optical system and hence the tweet, publicising the drug, is a contravention of the DMR(OA) Act, was the contention raised.

“I had, through an RTI recently, sought to know the status of the complaint I had filed before the DCGI that the pharma firm had violated provisions of DMR Act,” says Dr. Babu.

The RTI reply from the DCGI said that “With respect to contravention of DMR Act,1954, the matter was forwarded to FDCA, Gujarat vide letter Dated 25.09.2024 to take appropriate action as per the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.”

“The fact that the DCGI concurs with the specific violation of law that I had raised, aggravates the gravity of the situation that Entod pharmaceuticals finds itself in,” he says.

The Central Drugs Standard Control Organization (CDSCO), had on September 10, suspended Entod’s licence, till further orders, for making tall claims about the drug, for which it did not have the prior approval of the Central licensing authority.

In the permission given to the company, the indication for the drug was “for the treatment of presbyopia in adults”. However, Entod went a step ahead, when it claimed through its tweet that the drug will help people “eliminate” reading glasses.

The Drugs Controller General of India has approved Entod Pharmaceuticals’ PresVu eye drops, which is said to be a breakthrough in the treatment of presbyopia. The pharmaceutical company has already received approval for the eye drop from the Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO).

PresVu is India’s first eye drop, specially made for individuals suffering from presbyopia who are forced to read with glasses.

What Is Presbyopia?

Presbyopia is an age-related condition that makes it difficult to focus on near objects. Generally, people above 40 years of age suffer from this condition.

According to a report, 1.09 billion to 1.80 billion people globally are estimated to be suffering from presbyopia, highlighting the massive impact of this condition.

Presbyopia occurs naturally with ageing as the eye’s ability to focus declines.

This condition can have a significant impact on a person’s quality of life, affecting their ability to perform everyday tasks and maintain their lifestyle. Many realise they have presbyopia when they try to hold reading objects at arm’s length to see clearly. It can be detected by a simple examination of the eyes.

Speaking about PresVu, Nikhil K Masurkar, CEO, Entod Pharmaceuticals, said, “PresVu has been created through years of research and development. Its approval by DCGI is a major step in our mission to transform eye care in India.

PresVu: Key Benefits

Entod Pharmaceuticals has applied for a patent regarding the formulation and process of PresVu.

Entod’s formula not only provides relief from reading glasses but also gives an additional benefit to the patient — it helps lubricate the eyes.

The formula uses advanced dynamic buffer technology to rapidly adapt to the pH of tears. Its effect remains for a longer duration, while the eyes also remain protected.

Nikkhil K Masurkar, CEO, Entod Pharmaceuticals noted that PresVu was created after years of research and development.

“This DCGI approval is a major step forward in our mission to transform eye care in India,” he said.

Masurkar noted that PresVu is more than just a product; it’s a solution that works to improve the lives of millions of people by helping them see better.

‘Enhances Near Vision In 15 minutes’

Highlighting the benefits of PresVu for patients, Dr Aditya Sethi noted that Presbyopia has long been treated with reading glasses, contact lenses and surgical measures. With PresVu, it can be treated effectively as the eye drop improves near vision within 15 minutes.

The latest treatment can significantly improve the quality of life for many people, allowing them to perform everyday tasks easily, he stated.

The doctor further noted that it was important to monitor symptoms and consult a doctor if blurred near vision interferes with reading or other activities.

Commenting on the clinical potential of PresVu, Dr Dhananjay Bakhle said its approval was a promising achievement in the field of ophthalmology.

For presbyopia patients, this eye drop provides a non-invasive option that eliminates the need for reading glasses, he stated.