Safety And Efficacy of Ayurvedic Formulations

[Guest guest]

Hi Kunda,

Pleasure to hear from you rather than about Rota which put you down

for so long. May the soul of Rota rest in peace !

In 2008, during trip to Napa Valley in US, we went for a conducted

tour in wine yards and wine manufacturing factories. In one of the

best factories we saw that the wine filled casks were stored in a

closed room with pious atmosphere, where Buddhist chants were being

played contuously on audio system in soft voice. We were told that

such exposure to the wine makes it good etc; (God saves our livers!).

If this is practiced currently in one of the best factories of most

developed economy in the world, no suspicions for prayers making the

Ayurvedic formulations better. No pun intended.

Rest for Smita to answer you.

Vijay

>

> hello,

>  I quote some lines from authentic references in respect of the

heavy metal toxicity in ayurvedic preparations.

>  

>   " There is a technique of detoxification applied to heavy metals

and toxic herbs called samskaras, which is similar to the Chinese

pao zhi although the Ayurvedic technique is more complex and may

involve prayers as well as physical pharmacy techniques. "

>  

> " --states that contamination and carelessness during the modern

manufacturing processes, quicker than the safer traditional methods

of preparation, is to blame for the heavy level of toxicity in

traditional medicine. "

>  

> As regards the efficacy aspect here are some views.

>  

> "  A systematic review of Ayurveda treatments for rheumatoid

arthritis concluded that there was insufficient evidence, as most of

the trials were not done properly, and the one high-quality trial

showed no benefits. A review of Ayurveda and cardiovascular disease

concluded that the herbal evidence is not yet convincing, "

>  

> I call upon Smita Sontakke to give her experience in this respect.

> kunda

>

>

> Check out the all-new face of India. Go to

http://in./

>

[Guest guest]

Welcome Anand. We did wait for you but since there was no

information, I picke up the discussion.

Let the discussion benefit from your posts now.

Since we are midway, I request you to kindly provide answers to the

posers as well.

Vijay

>

> Hello All Members

>

> First I would like to thanks Dr Vijay Thawani for all needful he

is doing on

> Netrum in general and on this issue in particular.

>

> Why Ayurvedic Medicines are under scanner today?

> Whom contribution is it?

> What is needed to proceed in either direction?

> How a policy may be framed which make person accountable for the

cases of

> Ayurvedic formulations in larger interest of ailing humanity?

> Whether Drugs & Cosmetics Acts 1940 and Rules 1945 is effective to

achieve

> goals pertaining to global acceptance of Ayurvedic Formulation as

drug not

> as food supplement.

> Whether recently (2004) notified EU Directives and MLX s are

enough

> sufficient and with justification to nature of Ayurvedic System of

Medicine

> to regulate these medicines in European Union.

>

> How much NICCAM a subsidiary of NIH USA is fair enough in

regulations of

> these medicines?

>

> WHO as leader of Health policy how much contributing for the re

> establishment of TM /CAM in broader sense and for Ayurveda in

specific way.

>

> And in the end I would like to invite every one to think deeply

that how

> much and in what way contemporary science may be involved for

validation of

> safety and efficacy of Ayurvedic Medicines.

>

> Please provide input of your vision so that we may share and

potentiate our

> views in this regard.

>

> --

> Anand Chaudhary

> Associate Professor

> Deptt of Rasa Shastra

> (Ayurvedic Pharmaceutics)

> Faculty of Ayuveda

> Institute of Medical Sciences

> Banaras Hindu University

> VARANASI 221005

> Cell 9452074480

> 9889863866

> 0542-2366900®

>

[Guest guest]

Respected Dr Thawani & Dear All

To day is last opportunity of this slot to discuss and educate us

about Ayurvedic system of medicine in general and about formulations

in particular.We are very grateful to Dr Thawani for providing this

platform to us.

The question of safety and Efficacy of Ayurvedic formulations has

found many stake holders at present ,as every scientific organisation

such as Analytical labs of CSIR,DST,GTP Programme and toxicities

studies by IRTC Lucknow and over all IIIM Jammu is deeply involved in

validation of these medicines.More over IIT Kharagpur and Arya Vaidya

Sala Kottakkal are doing work for chemical characterisation of Rasa

Sindoor,a Ayurvedic medicine.I wish to submit that proper care is in

progress.

The group which should take moral responsibilities for defame of

these medicines are primarily manufacturers of Ayurvedic

medicines.Even after notification of GMP it has not be implemented

all over country.Again politicians are using their influence on every

machinery of Govt to extend the mandatory of limit of GMP.They are

quoting many reasons for the same including social,economical etc.But

I believe firmly that no reason can supersede the human health.Out of

9000 approx registered Ay Pharmacy only 10% are following suit of

GMP.This situation must be improved.

Stern actions aginst defaulters are the only remedies for improvement

this may be achieved by amending penal provisions in D & C Acts &

Rules.Mere fine of some thousand rupees for breaking the rules has no

meaning specially in comparison of huge profit their are churning

from the pharmaceuticals.

Many substances are exported as food supplement to avoid screening

under the provision of drug and result is JAMA papers on toxicity.If

a country is not accepting you as drug why one should take short cut

only for commercial benefit which is again defamatory in nature.

Recently Commission (2002) and EU directives have provided

some new measures for practise of Ayurveda and export import policy

of Ayurvedic medicines.There are precondition of existence of 15

years for a substance as medicine in EU market and if no toxicity

is reported then it may be practised legally.For rest all new

substances all data are required for its safety and efficacy before

coming in practise.

NICCAM is funding projects for studies on Ayurveda .But provisions

are so complicated that any person in India have to face many if and

Buts.Result is that many pseudo Ayurvedist are garnering funds

without real knowledge and contribution to the field.

In all these odds their are rays of hope that even in India we may do

plan good studies from all angles such as production ,analysis,and

clinical studies.

We need border less science for proper revelation and evaluation of

Ayurvedic system of medicine.

With regards,

Anand Chaudhary

Associate Professor

Deptt of Rasa Shastra

(Ayurvedic Pharmaceutics)

Faculty of Ayuveda

Institute of Medical Sciences

Banaras Hindu University

VARANASI 221005

Cell 9452074480

9889863866

0542-2366900®

[Guest guest]

Respected Dr Thawani & Dear All, I strongly agree with the thoughts of Dr Chaudhary and would like to add few points herewith. Rightly said by Dr Chaudhary that no reason can supersede the human health, and the GMP should be implemented very strictly. All drug manufacturers of Herbal and Ayurveda products must analyze the raw material for heavy metal and pesticides before producing even classical products. As all Ayurveda practitioners know that contra indications of many herbal drugs are clearly mentioned by Ayurveda classics. e.g. very popular drug like Haritaki is contra indicated during pregnancy for longer time ! or Vasa is contraindicated for Vaatik prakriti patients or Vaatik Swasa. So new rules may be firmed for

OTC products saled in india where the contra indications are mentioned. I always wonder when the OTC products saled in india contains drugs like Semicarpus anacardium or Papavare mentioned under Schedule E. Under GMP, separate rules should be firmed for the metalic, herbo-metalic or herbo mineral products and no any tom dick or harry should be allowed to manufacture Rasaushadhis.Mass avareness should be created regarding the safety and efficacy for using OTC products of Ayurveda for longer time then one month. I have seen many patients consuming metalic drugs even for more than 3 years, where Rasashashtra classics have clearly advocated them for shorter periods. So the dose and duration of any drug is a key point. This is a very long term matter and policy makers should come up and academicians should admit the moral responsibility to educate upcoming students of Ayurveda and practitioners regarding the safety

and efficacy as much as they can.

From: Vd Anand Chaudhary <ayurasabhaishja@...>Subject: Safety And Efficacy of Ayurvedic Formulationsnetrum Date: Tuesday, 13 January, 2009, 8:28 AM

Respected Dr Thawani & Dear All

To day is last opportunity of this slot to discuss and educate us

about Ayurvedic system of medicine in general and about formulations

in particular.We are very grateful to Dr Thawani for providing this

platform to us.

The question of safety and Efficacy of Ayurvedic formulations has

found many stake holders at present ,as every scientific organisation

such as Analytical labs of CSIR,DST,GTP Programme and toxicities

studies by IRTC Lucknow and over all IIIM Jammu is deeply involved in

validation of these medicines.More over IIT Kharagpur and Arya Vaidya

Sala Kottakkal are doing work for chemical characterisation of Rasa

Sindoor,a Ayurvedic medicine.I wish to submit that proper care is in

progress.

The group which should take moral responsibilities for defame of

these medicines are primarily manufacturers of Ayurvedic

medicines.Even after notification of GMP it has not be implemented

all over country.Again politicians are using their influence on every

machinery of Govt to extend the mandatory of limit of GMP.They are

quoting many reasons for the same including social,economical etc.But

I believe firmly that no reason can supersede the human health.Out of

9000 approx registered Ay Pharmacy only 10% are following suit of

GMP.This situation must be improved.

Stern actions aginst defaulters are the only remedies for improvement

this may be achieved by amending penal provisions in D & C Acts &

Rules.Mere fine of some thousand rupees for breaking the rules has no

meaning specially in comparison of huge profit their are churning

from the pharmaceuticals.

Many substances are exported as food supplement to avoid screening

under the provision of drug and result is JAMA papers on toxicity.If

a country is not accepting you as drug why one should take short cut

only for commercial benefit which is again defamatory in nature.

Recently Commission (2002) and EU directives have provided

some new measures for practise of Ayurveda and export import policy

of Ayurvedic medicines.There are precondition of existence of 15

years for a substance as medicine in EU market and if no toxicity

is reported then it may be practised legally.For rest all new

substances all data are required for its safety and efficacy before

coming in practise.

NICCAM is funding projects for studies on Ayurveda .But provisions

are so complicated that any person in India have to face many if and

Buts.Result is that many pseudo Ayurvedist are garnering funds

without real knowledge and contribution to the field.

In all these odds their are rays of hope that even in India we may do

plan good studies from all angles such as production ,analysis,and

clinical studies.

We need border less science for proper revelation and evaluation of

Ayurvedic system of medicine.

With regards,

Anand Chaudhary

Associate Professor

Deptt of Rasa Shastra

(Ayurvedic Pharmaceutics)

Faculty of Ayuveda

Institute of Medical Sciences

Banaras Hindu University

VARANASI 221005

Cell 9452074480

9889863866

0542-2366900( R)

Add more friends to your messenger and enjoy! Invite them now.

[Guest guest]

Respected Dr Thawani & Dear All, I strongly agree with the thoughts of Dr Chaudhary and would like to add few points herewith. Rightly said by Dr Chaudhary that no reason can supersede the human health, and the GMP should be implemented very strictly. All drug manufacturers of Herbal and Ayurveda products must analyze the raw material for heavy metal and pesticides before producing even classical products. As

all Ayurveda practitioners know that contra indications of many herbal

drugs are clearly mentioned by Ayurveda classics. e.g. very popular

drug like Haritaki is contra indicated during pregnancy for longer time

! or Vasa is contraindicated for Vaatik prakriti patients or Vaatik

Swasa. So new rules may be firmed for OTC products saled in

india where the contra indications are mentioned. I always wonder when

the OTC products saled in india contains drugs like Semicarpus

anacardium or Papavare mentioned under Schedule E. Under

GMP, separate rules should be firmed for the metalic, herbo-metalic or

herbo mineral products and no any tom dick or harry should be allowed

to manufacture Rasaushadhis.Mass avareness should be created

regarding the safety and efficacy for using OTC products of Ayurveda

for longer time then one month. I have seen many patients consuming

metalic drugs even for more than 3 years, where Rasashashtra classics

have clearly advocated them for shorter periods. So the dose and duration of any drug is a key point. This

is a very long term matter and policy makers should come up and

academicians should admit the moral responsibility to educate upcoming

students of Ayurveda and practitioners regarding the safety and

efficacy as much as they can.

With regards,

Dr Joban Modha

A. P.

Deptt of Rasa Shastra

(Ayurvedic Pharmaceutics)

Gujarat Ayurveda UniversityJamnagarMob: 09825273008From: Vd Anand Chaudhary <ayurasabhaishja@...>Subject: Safety And Efficacy of Ayurvedic Formulationsnetrum Date: Tuesday, 13 January, 2009, 8:28 AM

Respected Dr Thawani & Dear All

To day is last opportunity of this slot to discuss and educate us

about Ayurvedic system of medicine in general and about formulations

in particular.We are very grateful to Dr Thawani for providing this

platform to us.

The question of safety and Efficacy of Ayurvedic formulations has

found many stake holders at present ,as every scientific organisation

such as Analytical labs of CSIR,DST,GTP Programme and toxicities

studies by IRTC Lucknow and over all IIIM Jammu is deeply involved in

validation of these medicines.More over IIT Kharagpur and Arya Vaidya

Sala Kottakkal are doing work for chemical characterisation of Rasa

Sindoor,a Ayurvedic medicine.I wish to submit that proper care is in

progress.

The group which should take moral responsibilities for defame of

these medicines are primarily manufacturers of Ayurvedic

medicines.Even after notification of GMP it has not be implemented

all over country.Again politicians are using their influence on every

machinery of Govt to extend the mandatory of limit of GMP.They are

quoting many reasons for the same including social,economical etc.But

I believe firmly that no reason can supersede the human health.Out of

9000 approx registered Ay Pharmacy only 10% are following suit of

GMP.This situation must be improved.

Stern actions aginst defaulters are the only remedies for improvement

this may be achieved by amending penal provisions in D & C Acts &

Rules.Mere fine of some thousand rupees for breaking the rules has no

meaning specially in comparison of huge profit their are churning

from the pharmaceuticals.

Many substances are exported as food supplement to avoid screening

under the provision of drug and result is JAMA papers on toxicity.If

a country is not accepting you as drug why one should take short cut

only for commercial benefit which is again defamatory in nature.

Recently Commission (2002) and EU directives have provided

some new measures for practise of Ayurveda and export import policy

of Ayurvedic medicines.There are precondition of existence of 15

years for a substance as medicine in EU market and if no toxicity

is reported then it may be practised legally.For rest all new

substances all data are required for its safety and efficacy before

coming in practise.

NICCAM is funding projects for studies on Ayurveda .But provisions

are so complicated that any person in India have to face many if and

Buts.Result is that many pseudo Ayurvedist are garnering funds

without real knowledge and contribution to the field.

In all these odds their are rays of hope that even in India we may do

plan good studies from all angles such as production ,analysis,and

clinical studies.

We need border less science for proper revelation and evaluation of

Ayurvedic system of medicine.

With regards,

Anand Chaudhary

Associate Professor

Deptt of Rasa Shastra

(Ayurvedic Pharmaceutics)

Faculty of Ayuveda

Institute of Medical Sciences

Banaras Hindu University

VARANASI 221005

Cell 9452074480

9889863866

0542-2366900( R)

Connect with friends all over the world. Get India Messenger.

[Guest guest]

From: Vd Anand Chaudhary <ayurasabhaishja@...>Subject: Safety And Efficacy of Ayurvedic Formulationsnetrum Date: Tuesday, 13 January, 2009, 8:28 AM

Respected Dr Thawani & Dear AllTo day is last opportunity of this slot to discuss and educate us about Ayurvedic system of medicine in general and about formulations in particular.We are very grateful to Dr Thawani for providing this platform to us.The question of safety and Efficacy of Ayurvedic formulations has found many stake holders at present ,as every scientific organisation such as Analytical labs of CSIR,DST,GTP Programme and toxicities studies by IRTC Lucknow and over all IIIM Jammu is deeply involved in validation of these medicines..More over IIT Kharagpur and Arya Vaidya Sala Kottakkal are doing work for chemical characterisation of Rasa Sindoor,a Ayurvedic medicine.I wish to submit that proper care is in progress.The group which should take moral responsibilities for defame of these medicines are primarily manufacturers of Ayurvedic medicines.Even after

notification of GMP it has not be implemented all over country.Again politicians are using their influence on every machinery of Govt to extend the mandatory of limit of GMP.They are quoting many reasons for the same including social,economical etc.But I believe firmly that no reason can supersede the human health.Out of 9000 approx registered Ay Pharmacy only 10% are following suit of GMP.This situation must be improved.Stern actions aginst defaulters are the only remedies for improvement this may be achieved by amending penal provisions in D & C Acts & Rules.Mere fine of some thousand rupees for breaking the rules has no meaning specially in comparison of huge profit their are churning from the pharmaceuticals.Many substances are exported as food supplement to avoid screening under the provision of drug and result is JAMA papers on toxicity.If a country is not accepting you as

drug why one should take short cut only for commercial benefit which is again defamatory in nature.Recently Commission (2002) and EU directives have provided some new measures for practise of Ayurveda and export import policy of Ayurvedic medicines.There are precondition of existence of 15 years for a substance as medicine in EU market and if no toxicity is reported then it may be practised legally.For rest all new substances all data are required for its safety and efficacy before coming in practise.NICCAM is funding projects for studies on Ayurveda .But provisions are so complicated that any person in India have to face many if and Buts.Result is that many pseudo Ayurvedist are garnering funds without real knowledge and contribution to the field.In all these odds their are rays of hope that even in India we may do plan good studies from all angles such as production

,analysis,and clinical studies.We need border less science for proper revelation and evaluation of Ayurvedic system of medicine.With regards,Anand ChaudharyAssociate ProfessorDeptt of Rasa Shastra(Ayurvedic Pharmaceutics)Faculty of AyuvedaInstitute of Medical Sciences Banaras Hindu UniversityVARANASI 221005Cell 945207448098898638660542-2366900( R)

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[Guest guest]

Thanks Anand for the compliments.

The Editor of our NetRUM newsletter Dr Geer from Srinagar insists

timely contribution of article on discussion topic. Will you write

it or should I? If you write and send it to me, then I will add on

and it can be a joint publication. Choice is yours.

After the article is published, you can send the PDF of newsletter

to anyone.

Vijay

>

> > Hi,

> > Thanks to all for valuable inputs to the discussion. It was

indeed a

> > pleasure to see our experts from Ayurveda contributing to it.

Since

> > the interest in this topic was evident, we have arranged another

> > discussion on " Pharmacovigilance of Ayurvedic formulations " in

end

> > of March. Please see the forthcoming discussions in next post.

> >

> > To conclude this discussion:

> > - Ayurvedic formulations made in traditional way, accoding to

> > scriptures have proven efficacy.

> > - Ayurvedic formulations manufactired with GMP are safe, non

toxic

> > and efficacious.

> > - Undue criticism for Ayurvedic formulations is unwarranted and

has

> > some conflict of interest.

> > - Not all Ayurvedic formulations are safe. Some do have heavy

metal

> > content.

> > - The money makers in Ayurvedic industry; those who adopt short

cuts

> > in manufacturing; those who compromise by deleting the costly

> > ingredients; are responsible for bringing bad name to Ayurveda

> > - All Ayurvedic formulations should be treated at par with modern

> > medicine for quality monitoring, inspections and licensing.

> > - The excise and tax exemptions should be strictly reserved for

> > traditional Ayurvedic formulations and these should not be

extended

> > to multinational products which have originated in other

contries.

> > - Clinical trials to validate the efficacy and non toxicity

should

> > be performed to provide evidence for promoting use of Ayurvedic

> > formulations.

> > - Ayurvedic Vaidyas should be open to imbibe the good things from

> > other pathies and acculturate the existing positivity in medical

> > science.

> > - Ayurveda has the right to exist as pure science, as the pathy

of

> > the land in India, should be favoured for being the traditional

> > medicine of the land, integrated with modern medicine in country

of

> > origin and should not be considered as alternative medicine.

> >

> > Members are encouraged to post concluding remarks tonight or

latest

> > tomorrow morning.

> >

> > Vijay Thawani

> >

> >

> >

>

>

>

> --

> Anand Chaudhary

> Associate Professor

> Deptt of Rasa Shastra

> (Ayurvedic Pharmaceutics)

> Faculty of Ayuveda

> Institute of Medical Sciences

> Banaras Hindu University

> VARANASI 221005

> Cell 9452074480

> 9889863866

> 0542-2366900®

>