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.

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<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

India’s apex drug regulator has announced that foreign vaccines like Pfizer and Moderna will no longer have to clear India-specific trials. The Drug Controller General of India (DCGI) has done away with such requirements in order to speed up vaccine imports.

DCGI relaxes norms for clearing foreign vaccines, no local trials for Pfizer and Moderna

The Drugs Controller General of India (DCGI) approved the Serum Institute's coronavirus vaccine 'Covishield' and Bharat Biotech's 'Covaxin', making them India's first vaccines against the pandemic.

India: DCGI approves Serum & Bharat Biotech vaccines for emergency use

Indian Pharmaceuticals firm Bharat Biotech is seeking emergency authorisation of its Coronavirus vaccine 'Covaxin'. This comes after Pfizer & Serum institute producing AstraZeneca vaccine have applied for the emergency use authorisation from DGCI.

India: Bharat Biotech latest to seek emergency use authorisation

The Serum Institute of India (SII) on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine 'Covishield' in the country,

News Alert: Serum institute seeks emergency use nod for 'Covishield' vaccine in India

The US company Pfizer Inc, whose vaccine was recently approved by the British government, has written to the Drugs Controller General of India (DGCI) for emergency use authorisation of its coronavirus vaccine in India.

News Alert: Pfizer seeking emergency NOD from DCGI for India

The Drug Controller General of India (DCGI) has granted permission to use the anti-viral drug favipiravir for COVID-19 patients.

However, the drugis only for&nbsp;"restricted emergency use" in&nbsp;mild to moderate cases of COVID-19, according to official sources.

The nod from DCGI came at a point when there has been a rapid increase in the number of coronavirus cases on a daily basis in the country.

<a href="https://www.wionews.com/world/covid-19-human-trials-for-potential-vaccine-begins-initial-results-expected-in-august-307069">Also read|&nbsp;COVID 19: Human trials for potential vaccine begins; initial results expected in August</a>

The officials have also granted fast-tracked permission to Glenmark, a&nbsp; pharmaceutical company, to manufacture and market the anti-viral tablets.

This approval has been granted based on the evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak. It is for restricted emergency use in India.

The doctors and hospitals have been told to check that all patients have a signed consent form before the tablets are used for treatment.

<a href="https://www.wionews.com/world/coronavirus-vaccine-could-be-on-market-in-mid-2021-says-unlisted-german-company-306522">Also read|&nbsp;Coronavirus vaccine could be on market in mid-2021, says unlisted German company</a>

A senior health ministry official told a news agency, "The DCGI has approved favipiravir drug for restricted emergency use for the treatment of mild to moderate cases of COVID-19. This emergency use authorisation has been given on several conditions. The company has to take written consent from each patient. Also, in the first 1,000 patients, the pharma company has to do active post-market surveillance to evaluate the efficacy and safety of the drug being administered."

"The patient will receive a dose of 3,600 mg on the first day as a loading dose. After this, the patient would receive 1,800 mg for some days which will depend upon his/her viral load," he said.

"The drug cannot be given to patients with severe liver and renal diseases including pregnant and lactating mother," added the official.

Now that permission has been granted and the company has to get the license to manufacture from the Central Drugs Standard Control Organisation (CDSCO) under the Drug and Cosmetic Act and Rules.&nbsp;

(With inputs from ANI)

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The Drug Controller General of India (DCGI) has granted permission to use the anti-viral drug favipiravir for COVID-19 patients. However, the drugis only for "restricted emergency use" in mild to moderate cases of COVID-19, according to official sources.

The Drug Controller General of India (DCGI) has granted permission to use the anti-viral drug favipiravir for COVID-19 patients. However, the drugis only for "restricted emergency use" in mild to moderate cases of COVID-19, according to official sources. The nod from DCGI came at a point when there has been a rapid increase in the number of coronavirus cases on a daily basis in the country. Also read| COVID 19: Human trials for potential vaccine begins; initial results expected in August The officials have also granted fast-tracked permission to Glenmark, a pharmaceutical company, to manufacture and market the anti-viral tablets. This approval has been granted based on the evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak. It is for restricted emergency use in India. The doctors and hospitals have been told to check that all patients have a signed consent form before the tablets are used for treatment. Also read| Coronavirus vaccine could be on market in mid-2021, says unlisted German company A senior health ministry official told a news agency, "The DCGI has approved favipiravir drug for restricted emergency use for the treatment of mild to moderate cases of COVID-19. This emergency use authorisation has been given on several conditions. The company has to take written consent from each patient. Also, in the first 1,000 patients, the pharma company has to do active post-market surveillance to evaluate the efficacy and safety of the drug being administered." "The patient will receive a dose of 3,600 mg on the first day as a loading dose. After this, the patient would receive 1,800 mg for some days which will depend upon his/her viral load," he said. "The drug cannot be given to patients with severe liver and renal diseases including pregnant and lactating mother," added the official. Now that permission has been granted and the company has to get the license to manufacture from the Central Drugs Standard Control Organisation (CDSCO) under the Drug and Cosmetic Act and Rules. (With inputs from ANI)

COVID 19: Anti-viral drug Favipiravir gets DCGI nod for 'restricted emergency use'

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