You must have heard about the launch of a new eye drop in the market that claimed to reduce dependency on reading glasses. The Drug Controller General of India (DCGI) has now suspended the permission to make and sell the eye drop, which was earlier awarded to Entod Pharmaceuticals.

The DGCI mentioned that the company&nbsp;made claims for the drug 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 response to the claim of being the "first eye drop in India to reduce the need for reading glasses", the DGCI order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India.

"After perusal of your reply, it is clear that you had failed to respond to the queries as put to you," the DGCI order said.

Considering 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, it added.

"In view of the 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.

&nbsp;

<h2>Entod Pharmaceuticals to go to court</h2>

The company in its statement denied any unethical representation and vowed to take the DGCI to court over the suspension order.

"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. All facts disclosed to the media were strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India," the company said.

<h2>Claims made by the company</h2>

Earlier, the company claimed its Presvu Eye Drops help people overcome presbyopia, a vision-related condition that usually arises above 40. Presbyopia makes it difficult for the patient to focus on close objects.

DGCI had earlier issued a notice to the company on Sep 5 in connection with these claims.

It also clarified that the permission to make this claim publicly was never given to the company.

The regulator also questioned the claim that the eye drop offered a non-invasive option to enhance near vision.

"You had tried to justify the claims for the product for which no approval was granted," the DGCI said.

(With inputs from agencies)

You must have heard about the launch of a new eye drop in the market that claimed to reduce dependency on reading glasses. The Drug Controller General of India (DCGI) has now suspended the permission to make and sell the eye drop, which was earlier awarded to Entod Pharmaceuticals.

You must have heard about the launch of a new eye drop in the market that claimed to reduce dependency on reading glasses. The Drug Controller General of India (DCGI) has now suspended the permission to make and sell the eye drop, which was earlier awarded to Entod Pharmaceuticals. The DGCI mentioned that the company made claims for the drug 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 response to the claim of being the "first eye drop in India to reduce the need for reading glasses", the DGCI order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India. "After perusal of your reply, it is clear that you had failed to respond to the queries as put to you," the DGCI order said. Considering 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, it added. "In view of the 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. Entod Pharmaceuticals to go to court The company in its statement denied any unethical representation and vowed to take the DGCI to court over the suspension order. "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. All facts disclosed to the media were strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India," the company said. Claims made by the company Earlier, the company claimed its Presvu Eye Drops help people overcome presbyopia, a vision-related condition that usually arises above 40. Presbyopia makes it difficult for the patient to focus on close objects. DGCI had earlier issued a notice to the company on Sep 5 in connection with these claims. It also clarified that the permission to make this claim publicly was never given to the company. The regulator also questioned the claim that the eye drop offered a non-invasive option to enhance near vision. "You had tried to justify the claims for the product for which no approval was granted," the DGCI said. (With inputs from agencies)

DGCI suspends approval for eye drop firm claimed reduced dependence on reading glasses

A pharmaceutical company based in the Indian city of Mumbai said on Tuesday (Sep 3) that it received approval from the Drug Controller General of India (DCGI) to market eye drops for the treatment of presbyopia.

A pharmaceutical company based in the Indian city of Mumbai said on Tuesday (Sep 3) that it received approval from the Drug Controller General of India (DCGI) to market eye drops for the treatment of presbyopia. Entod Pharmaceuticals said it received final approval for PresVu eye drops and plans to introduce them in the domestic market in the first week of October. A report by the news agency PTI said that the DCGI approval follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). PresVu will reduce dependency on reading glasses PresVu is the first eye drop in India that has been specifically developed to reduce dependency on reading glasses for people affected by presbyopia. Also read | Worms that live in eyes and are transmitted by flies can reach humans, experts fear According to Mayo Clinic, presbyopia is the gradual loss of your eye's ability to focus on nearby objects. The condition usually becomes noticeable in your early to mid-40s and continues to worsen until around age 65. Mayo Clinic says that presbyopia can be corrected with eyeglasses, contact lenses or even surgery. Citing industry stands, the PTI report on Tuesday said that 1.09-1.8 billion individuals globally are estimated to be affected by presbyopia. 'PresVu is more than just a product' Speaking to PTI, Entod Pharmaceuticals' Chief Executive Officer (CEO) Nikkhil K Masurkar said that the DCGI approval was a major step forward in the company's mission to transform eye care in India. "PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence," Masurkar added. Asked about the company's future plans, Masurkar said the focus would be to cater to demand in domestic and emerging markets like Africa and South East Asia. He also pointed out that the company aimed to innovate products in India and then out-licence them in the US market. (With inputs from agencies)

Eye drops to reduce dependency on reading glasses to hit Indian market soon

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DGCI suspends approval for eye drop firm claimed reduced dependence on reading glasses

Eye drops to reduce dependency on reading glasses to hit Indian market soon