[reignofchaos]

Originally Posted by DCEite

Glenmark is based in Mumbai but Favipiravir is not. Neither is Remdesivir. I am talking about the medicinal compounds.

Edit: My whole point is that it is good to be sceptical. Whether its allopathic or ayurvedic, we need to be cautious of the claims made by the manufacturers. But we cannot be selectively blind in our trust for allopathy and at the same time ridicule Ayurveda/traditional medicine by making atrocious jokes like the one posted in this thread (that the Herbalists need to infect themselves first and then show proof of their cure). Its not only about this absurd joke, but in general the mindset which some of us educated Indians have.
This mindset has to change and we need to be more open.

On one hand you say one needs to be skeptical and at the same time you give this crap a free pass?

This one deserves atrocious jokes for sure. 100% effective cure? What on earth are they smoking?

i) Do they have any research on what pathways this drug takes and to what targets it binds to?
ii) Did they do controlled clinical trials?
iii) Did they publish anything in a journal of repute?
iv) Did they get the drug cleared by the FDA or a similar authority of repute?
v) Do they even have a list of the exact chemical composition and did they get their samples tested by any lab?

Since the answer to all the above is no, this 'whatever it is' (i won't call it a drug or medicine) is as bad as hokum.

Also just to make it clear, I have huge doubts on the efficacy of Remdesivir or Favirparavir. Neither are proven in treatment of covid19 and they are being used without much testing and might be equally ineffective. However there is one difference - they are undergoing controlled trials and the CEOs of the companies involved are not making ridiculous blanket statements.

[DCEite]

Hi reignofchaos,

Please see below:

i) Do they have any research on what pathways this drug takes and to what targets it binds to?

Yes they have identified compounds in Tulsi, Giloy and Ashwagandha that bind to specific target. You can read up the press release for more details.

ii)

Did they do controlled clinical trials? -

Yes, they did ! You need to read more.

iii)

Did they publish anything in a journal of repute?

-
No . Is it a pre-requisite to launch a drug ?

iv)

Did they get the drug cleared by the FDA or a similar authority of repute?

Do Ayurvedic medicines require FDA approval ? I don't think so mate.

v)

Do they even have a list of the exact chemical composition and did they get their samples tested by any lab?

Exact chemical composition of Tulsi.Giloy and Ashwagandha is freely available.

Since the answer to all the above is no, this 'whatever it is' (i won't call it a drug or medicine) is as bad as hokum.

Also just to make it clear, I have huge doubts on the efficacy of Remdesivir or Favirparavir. Neither are proven in treatment of covid19 and they are being used without much testing and might be equally ineffective. However there is one difference - they are undergoing controlled trials and the CEOs of the companies involved are not making ridiculous blanket statements.[/quote]

[reignofchaos]

Originally Posted by DCEite

Hi reignofchaos,

Please see below:

I read their press release - it is pure bull written by a 10 year old. From that memo, it is clear, they don't even understand what a pathway means. My wife who is in the field of drug discovery for a large indian firm looked at it and couldn't control her laughter - I haven't seen her laugh so hard.

Their trials they claim of 50 was not controlled by a 3rd party so it is null an void. Trials are typically done for thousands under extremely controlled circumstances. That doesn't count as a trial.

[DCEite]

Originally Posted by reignofchaos

I read their press release - it is pure bull written by a 10 year old. From that memo, it is clear, they don't even understand what a pathway means. My wife who is in the field of drug discovery for a large indian firm looked at it and couldn't control her laughter - I haven't seen her laugh so hard.

Their trials they claim of 50 was not controlled by a 3rd party so it is null an void. Trials are typically done for thousands under extremely controlled circumstances. That doesn't count as a trial.

I cannot comment on your understanding of press release, but one thing i would like to make clear from your earlier post that they are not claiming "100% cure".

They only mentioned that in the clinical trial, 69.9% of the patients receiving the Patanjali drug therapy were found to be COVID-19 negative on third day, and all 100% by 7th day. This is in comparison to the placebo group. This is no way means that 100% patients are guaranteed to be cured who receive this treatment. That's absurd comment whoever made this and wherever you read it.

And the trial was not on 50 patients. AFAIK it was 150. By the way, since you have some knowledge on drug discovery, what is the minimum criteria for number of patients to be enrolled for a clinical trial ?

By the way, did Favipiravir or Remdesivir had 3rd party controlled clinical trials in India before the launching ? Go figure.

[AZT]

Originally Posted by reignofchaos

My wife who is in the field of drug discovery for a large indian firm looked at it and couldn't control her laughter - I haven't seen her laugh so hard.

Their trials they claim of 50 was not controlled by a 3rd party so it is null an void. Trials are typically done for thousands under extremely controlled circumstances. That doesn't count as a trial.

Thank you for stating this. For some reason a sample of 280 asymptomatic / mildly asymptomatic is being considered as a 'clinical trial'.
I don't know if I should be amused that Baba actually managed to pull this Coronil thing off or sad that he will never see the back of a jail cell.

[reignofchaos]

Originally Posted by DCEite

I cannot comment on your understanding of press release, but one thing i would like to make clear from your earlier post that they are not claiming "100% cure".

They only mentioned that in the clinical trial, 69.9% of the patients receiving the Patanjali drug therapy were found to be COVID-19 negative on third day, and all 100% by 7th day. This is in comparison to the placebo group. This is no way means that 100% patients are guaranteed to be cured who receive this treatment. That's absurd comment whoever made this and wherever you read it.

No third party exists to verify these results. Nor were they done in a controlled manner - there are multiple protocols that need to be followed for a trial. The biggest of those factors is independent third party verification.

And the trial was not on 50 patients. AFAIK it was 150. By the way, since you have some knowledge on drug discovery, what is the minimum criteria for number of patients to be enrolled for a clinical trial ?

By the way, did Favipiravir or Remdesivir had 3rd party controlled clinical trials in India before the launching ? Go figure.

150 or 50 or whatever is their claim. Since there is no third party to verify the same, they remain just that - claims.

As for trials of favirparavir - Glenmark completed their third stage trials in June. Sample size was 150 or so. This isn't enough IMHO and I anyways have doubts on this drug's efficacy.

https://www.clinicaltrialsarena.com/...-trial-begins/

Cipla is doing a larger stage 3 trial with 600-700 individual cases. Details here:

https://www.news18.com/news/india/sc...l-2684253.html

Remdesivir - worldwide trials are listed here:

https://www.gilead.com/purpose/advan...linical-trials

[JithinR]

Originally Posted by DCEite

By the way, did Favipiravir or Remdesivir had 3rd party controlled clinical trials in India before the launching ? Go figure.

Favipiravir has already gone through multiple phase 3 trails in different countries spanning multiple continents as a possible treatment for influenza(Also, these trails by the time they reach Phase 3 have more than 2000+ subjects not in a few hundred). It has since been suggested to be a possible drug to treat other viral outbreaks since then.

In India it has been granted permission to be clinically tested by CDSCO. Attached is the downloadable pdf from their site that explains all the testing pre-requisite, conditions and approval criteria.

It clearly mentions that the approval to do the trials is part of the accelerated approval to fight COVID-19 and even at this point towards the end it simply states:



Please try and understand that drugs that are being used internationally since many years don't need to be tested in every single country. This is simply because these drugs have undergone rigorous tests.

Another analogy that I can think of is that our DGCA is not even capable of testing and approving civilian aircraft. We simply depend on FAA to do this for us.

Now, if you are actually interested in having a discussion based on scientific arguments backed up by proper clinical trials and not stupid press release bulletins please go ahead and do the same simple google search for Remdesivir.

[DCEite]

Originally Posted by reignofchaos

As for trials of favirparavir - Glenmark completed their third stage trials in June. Sample size was 150 or so. This isn't enough IMHO and I anyways have doubts on this drug's efficacy.

https://www.clinicaltrialsarena.com/...-trial-begins/

Cipla is doing a larger stage 3 trial with 600-700 individual cases. Details here:

https://www.news18.com/news/india/sc...l-2684253.html

Remdesivir - worldwide trials are listed here:

https://www.gilead.com/purpose/advan...linical-trials

Again the point is that why did Cipla launch the drug before completing the stage 3 trial ? Tomorrow Patanjali can claim the same that they are in the process of stage 3 trials. Then why bash selectively Patanjali.

And as you mentioned, are these trials done done in India 3rd party controlled ? I doubt.

[reignofchaos]

Originally Posted by DCEite

Again the point is that why did Cipla launch the drug before completing the stage 3 trial ? Tomorrow Patanjali can claim the same that they are in the process of stage 3 trials. Then why bash selectively Patanjali.

And as you mentioned, are these 3rd party controlled trials being done in Inda? I doubt.

As Jithin mentioned, this is not a new drug and has been tested in many countries before - it is simply being repurposed. You are grasping at straws here.

[JithinR]

Originally Posted by DCEite

Again the point is that why did Cipla launch the drug before completing the stage 3 trial ? Tomorrow Patanjali can claim the same that they are in the process of stage 3 trials. Then why bash selectively Patanjali

Simple google search sir! Please note that EUA and it other fancy names like 'accelerated approvals' are not equivalent to 'FDA approval' or 'CDSCO approval'.

You can get a sense of how cautious they are about providing this drug emergency use authorization if you just skim the text.

https://www.fda.gov/news-events/pres...d-19-treatment

As for Patanjali, like I had mentioned in one of my previous posts on this subject if they had the clinical test results ready before they went on the media publicity stunt then we wouldn't be arguing here about the possible efficacy of the drug rather I would be asking you if you know where I can get my hands on it. As of now, Patanjali is calling this whole thing as 'communication gap'!

https://www.livemint.com/news/india/...925595782.html

[archat68]

Originally Posted by DCEite

iii) - No . Is it a pre-requisite to launch a drug ?
iv) - Do Ayurvedic medicines require FDA approval ? I don't think so mate.

v) - Exact chemical composition of Tulsi.Giloy and Ashwagandha is freely available.

Please read the General Guidelines for Drugs Development of Ayuvedic medicines published by Ayush ministry.

The Regulatory approval procedure of the therapeutic agent in case of new drug clearly states that in case of a new drug both "proof from published literature"and "proof of effectiveness" is required which needs to be submitted to the Central Authority i,e the Ayush Ministry for grant of manufacturing permission (page 61 of the General Guidelines For Drug Development Of Ayurvedic Formulations Published By Central Council For Research In Ayurvedic Sciences, Ministry of AYUSH, Government of India, New Delhi) which Patanjali obviously violated.

Moreover, for manufacturing any drug a licence from the State Drug Controller is required to be obtained. In case of drug with a New or unsubstantiated claim unless the Central authority gives a nod, State authority can not grant a manufacturing licence for such product.

I have nothing personal against Patanjali, but laws are being violated and people are being mislead without proper scientific evidence.

PS: I'm a professional in the regulatory field.

The link from the Ayush ministry:
https://www.ayush.gov.in/docs/guidel...evelopment.pdf

[DCEite]

Originally Posted by archat68

Please read the General Guidelines for Drugs Development of Ayuvedic medicines published by Ayush ministry.

The Regulatory approval procedure of the therapeutic agent in case of new drug clearly states that in case of a new drug both "proof from published literature"and "proof of effectiveness" is required which needs to be submitted to the Central Authority i,e the Ayush Ministry for grant of manufacturing permission (page 61 of the General Guidelines For Drug Development Of Ayurvedic Formulations Published By Central Council For Research In Ayurvedic Sciences, Ministry of AYUSH, Government of India, New Delhi) which Patanjali obviously violated.

......

Well, lets not jump to conclusions. The file is with Ayush ministry now and only on verification of all standard set of procedures and approvals, will the permission be granted for sale. We need to wait and watch.

[archat68]

Originally Posted by DCEite

Well, lets not jump to conclusions. The file is with Ayush ministry now and only on verification of all standard set of procedures and approvals, will the permission be granted for sale. We need to wait and watch.

The process is first obtain permission and then go public.

This is punishable by multiple accounts, manufacturing without licence and under Section 4 of Drugs and Magic Remedies Act (Objectionable advertisements). Right now they can land up in jail along with fine.

[hserus]

Originally Posted by DCEite

Well, lets not jump to conclusions. The file is with Ayush ministry now and only on verification of all standard set of procedures and approvals, will the permission be granted for sale. We need to wait and watch.

Nowhere is the Ayush ministry empowered to authorize "treatment" of covid - they can at the most approve immunity boosters.

Besides COVID treatment is not under their remit it is under the ministry for health. So herbal nostrums, sugar pills, gaumutra etc are not going to be any sort of a cure for covid or anything else (perhaps some churans may cure constipation with the same level of success as allopathic tablets but that's it)

https://www.factchecker.in/experts-c...reat-covid-19/

[DCEite]

Originally Posted by hserus

Nowhere is the Ayush ministry empowered to authorize "treatment" of covid - they can at the most approve immunity boosters.

When did i say they are authorizing it as "treatment". Ofcourse it will be approved as immunity boosters. Not because the drug itself is not curative or not, but because of the technicality of how Ayush functions and what is in its domain.

So herbal nostrums, sugar pills, gaumutra etc are not going to be any sort of a cure for covid or anything else (perhaps some churans may cure constipation with the same level of success as allopathic tablets but that's it)

https://www.factchecker.in/experts-c...reat-covid-19/

I am not sure about your fixation with "GauMutra" and what that link has to do with the issue we are discussing, but the fact is that it is not a "blanket claim" which Patanjali has come about this time. They have performed randomised placebo controlled clinical trials on the same and the results state that 69.9% of the patients taking this drug turned Covid negative in 3 days and all 100% turned Covid negative on completion of 7 days. Ofcourse one could argue on the sample size but thats a different topic.

Just because Ministry or Ayush cannot label the Ayurvedic medicine as a "cure" does not mean the medicine itself cannot cure the disease in real world application. It is just a technicality. An ayurvedic medicine does not go through the same set of steps as allopathic drug for approvals and regulations. I hope you get the drift.


Anyway, i rest my case here. Let the Ayush ministry/Drug controller of India decide on this drug and its sale. And i hope it works well to reduce the mortality rates of Covid-19 in India. In the same way i hope for FabiFlu and Remdesivir too.