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  • DCGI suspends...

DCGI suspends permission to Entod Pharma to manufacture, market PresVu, What next for the Company?

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-12T15:06:46+05:30  |  Updated On 12 Sept 2024 3:11 PM IST
DCGI suspends permission to Entod Pharma to manufacture, market PresVu, What next for the Company?
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New Delhi: In response to the various alleged misleading claims made by Entod Pharma in respect to its Opthalmologic product, Drugs Controller General of India (DCGI) has suspended permission given to it for the manufacturing, and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v for the treatment of Presbyopia in adults.

The permission is suspended till further order under-the provisions of Rule 84 of the New Drugs and Clinics trials Rules, 2019 of the Drugs and Cosmetics Act, 1940

The Drug regulator has said that the Company had tried to justify the claims for the product for which no approval was granted.

The Directorate had granted permission on August 20 to the Company for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v for the treatment of Presbyopia in adults. Following this, a press conference was organized by the company where several misleading claims were allegedly made by the company officials which finally led to several media articles spreading misleading claims and information in the public.

Medical Dialogues team had done a fact-check story in this matter, which can be accessed on the link below

Read Here: Fact Check: Can Entod Pharma's PresVu get rid of reading glasses?

Thereafter on September 4, a notice was issued by the regulator regarding various claims made by the Company in various news articles on Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/, following which the Company has submitted response in this regard.
1) Claim 1- "first eye drop in India designed to reduce the need for reading glasses"
Company Submission to DCGI : In response to the claim 'first eye drop in India designed to reduce the need for reading glasses", Entod stated that there are currently no other eye drops approved for the treatment of Presbyopia in India.

DCGI Response: In this regard, Drug regulator informed the company that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses.

2 ) Claim 2: Non-invasive option that can enhance near vision without the need for reading glasses

Company Submission to DCGI: In response to the another claim "this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses' the Company stated that in the clinical trial conducted, subjects did not wear glasses to participate etc.

DCGI Response:
For which, Drug regulator informed the Company that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% wlv 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.
3) Claim 3: PresVu can provide an advanced alternative that augments near vision within 15 minutes
Company Submission to DCGI: In response to a different claim "PresVu can provide an advanced alternative that augments near vision within 15 minutes'', the Company submitted that one doctor has evaluated the drug product as compared to reading glasses.
DCGI Response: In this regard, Drug regulator informed the Company that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% 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.
"After a perusal of your reply, it is clear that you had failed to respond to the queries as put to you. You had tried to justify the claims for the product for which no approval was granted. And also, whereas it is clear that you have not obtained any prior approval from the Central Licencing Authority to make such claims for the said drug product as mentioned above. Thus, you have violated the Condition No. (vi) of the permission No. MF/SND/24/000092 dated 20.08.2024 issued to you for 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. Also considering the various media reports, there is a likelihood of the general public being misled by the claims made by you, for which no approval was granted,"
Drug regulator
stated
"In view of above and considering the public interest, the permission No MF/SND/24/000092 dated 20.08.2024 issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% wiv vide is hereby suspended till further order under-the provisions of Rule 84 of the New Drugs and Clinics trials Rules, 2019 of the Drugs and Cosmetics Act, 1940,"the order noted.
ENTOD To approach Court

Following the order, ENTOD CEO Masurkar said in a statement that the company will challenge this suspension in the court.

"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. According to a PTI report, the CEO said that the Company has got suspension order with no reference to any specific violation of 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 added.


Pilocarpine Hydrochloride Ophthalmic SolutionPresbyopiaentod pharmaentod pharma newsDCGIpresvu
Source : With inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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