Safety and Efficacy of Ayurvedic Formulations: Attn ALL

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Colleagues, Please go through the QA session about Ayurveda, you will find it very useful, in terms of knowing it very well.Q.1 WHAT IS AYURVEDA?"AYURVEDA"

is made up of two words-Ayuh and Veda. Ayuh means life and Veda means

knowledge or science. Thus "AYURVEDA¢ in totality means ¡Science of

life¢. It incorporates all aspects of life whether physical,

psychological, spiritual or social. What is beneficial and what is

harmful to life, what is happy life and what is sorrowful life; all

these four questions and life span allied issues are elaborately and

emphatically discussed in Ayurveda. It believes the existence of soul

before birth and after death too.Q.2 WHAT IS THE ORIGIN OF AYURVEDA?Ayurveda,

the ancient most health care system originated with the origin of

universe. With the inception of human life on earth Ayurveda started

being applied. The antique vedic texts have scattered references of

Ayurvedic Remedies and allied aspects of medicine and health.

Atharva-veda mainly deals with extensive Ayurvedic information. That is

why Ayurveda is said to be the off shoot of Atharva Veda.Q.3 WHAT IS THE AYURVEDIC VIEWPOINT OF STRUCTURE AND FUNCTIONS OF BODY?Universe

as well as human body are made up of five basic elements colectively

called ¡Panch Mahabhootas¢. These are Aakash (Ether), Vayu (Air),

Agni(Fire), Aapa (Water) and Prithvi (Earth). The sixth mandatory

component of life is Atma (life spirit) without which life ceases. The

human body is made up of Doshas (Bio-humours), Dhatus(Body matrix) and

Malas (excretable products). Vata, Pitta and kapha, known as Tridoshs

are physiological entities of the body which are responsible for

carrying out all the functions of the body. Dhatus are the structural

entities of thebody. These are Rasa (Plasma), Rakta (Blood cells),

Mamsa (Muscular tissue), Meda (Fatty tissue), Asthi (Bony tissue),

Majja (Bone marrow) and Shukra (Hormonal and other secretions of

genital). Agni (Metabolic fire) is in thirteen different forms and

carries out the whole metabolism of the body. The waste products of the

body which are excretable are produced in the body as bye-products of

metabolism. These are known as malas which include pureesh (faeces),

Sweda (sweat) and Mutra (urine). All biotransformations within the body

occur through Srotases (body channels) which are the sites for action

of agni. Q.4 WHAT IS THEBASIC PHILOSOPHY OF HEALTH, DISEASE AND TREATMENT IN AYURVEDA?As

per Ayurveda, ¡Health¢ is a state of equilibrium of normal functions of

doshas, Dhatus, malas and Agni with delighted body, mind and soul. It

means that when Dosh-Dhatu-Malas and Agni are constantly in a state of

functional equilibrium, then the health is maintained. Otherwise

distortion of the equilibrium results into diseases. Erratic lifestyle

is believed to be one of the basic causes behind the failure of

mechanism of maintaining equilibrium.Treatment

either with or without drugs and application of specific rules of diet,

activity and mental status as described, disease wise, brings back the

state of equilibrium i.e. health.Q.5 HOW IS DIAGNOSIS DONE IN AYURVEDA?Diagnostic

procedures in Ayurveda are two pronged; one is aimed to establish the

state and type of pathology and second to decide the mode of treatment

tobe applied. The former implies examination of the patient and make

different investigations to diagnose the disease entity. Inspection,

palpation, percussion and interrogation are the main modes of physical

examination. The second type of examination is to assess the strength

and physical status of the individual so that accordingly the type of

management required could be planned. For this examination of Prakriti

(Body constitution), Saar (Tissue quality), Samhnan (physique), Satva

(Mental strength), Satamya (specific adaptability), Aaharshakti (diet

intake capacity), Vyayaam shakti (exercise capacity) and Vaya (age) is

done. On the basis of this examination the individual is decided to be

having Pravar bal (excellent strength), Madhyam Bal (moderate strength)

or Heen Bal (low strength).Q.6 WHAT ARE THE MODES OF AYURVEDIC TREATMENT?There

exists eight divisions of Ayurvedic therapeutics, namely Kayachikitsa

(Internal medicine), Shalya (Surgery), Shalkya (Otorhinolaryngology and

Opthalmology), Kaumr Bhritya (Paediatrics, Gynaecology and Obstetrics)

Agad tantra (Toxicology), Rasayana (Gerentorology), Vajikaran

(Aphrodisiacs) and Bhoot Vidya (Psychiatry).The

principles of treatment are Shodhan (purificatory), Shaman (palliative

and conservative), Nidan parivarjan (avoidance of causative and

prescipitating factors of disease) and Pathya Vyavastha (do¢s and

don¢ts regarding diets lifestyle). Shodhan therapy includes Vamana

(medically induced emesis), Virechana (medically induced laxation),

Vasti (medicated enema), shirovirechana (administration of medicines

through nose) and Raktmokshan (Blood letting). These therapeutic

procedures are collectively known as Panchkarma. Before executing Panch

karma treatment Snehan (olation) and Swedan (getting perspiration) are

to employed first.Q.7 WHAT ARE THE MAIN CLASSICAL REFERENCE BOOKS OF AYURVEDA?The

main classical texts for reference of Ayurvedic principles comprise of

Charak Samhita, Susrut Samhita, Astang Hridaya, Sharangdhar Samhita,

Madhav Nidan, Kashyap Samhita, Bhavprakash and Bhaisajya Ratnavali etc.Q.8 WHERE DO RAW MATERIALS FOR MANUFACTURING AYURVEDIC MEDICINES COME FROM?What

ever is natural whether belonging to plants or animals or minerals: all

are considered the source of raw material for Ayurvedic medicines.

However 600 medicinal plant products, 52 minerals and 50 animal

products are commonly used.Q.9 HOW ARE AYURVEDIC MEDICINES MARKETED?Ayurvedic

medicines are marketed in various forms. The main ones are tablets,

pills, powders, fermentation products (Asva-arishta), decoctions,

medicated fats (Ghrita and Tel). For topical use drops, creams,

lotions, liniments and ointments are available. Dried plant extracts in

capsule form are also in use presently.Q.10 IS THERE SCOPE FOR AYURVEDA IN THE CONTEMPORARY PERIOD?Ayurveda

has a wide scope as far as the prevention of disease, promotion of

health and its preservation are concerned. Lifestyle rules mentioned in

Ayurvedic texts if applied rigorously give definite results. Lifestyle

related diseases, drug abuse, degenerative diseases, auto immune

diseases and certain metabolic and allergic disorders are well

manageable with Ayurvedic techniques and medicaments. Q.11 IS THERE ANY RATIONALE BEHIND INTEGRTING AYURVEDA AND WESTERN MEDICINE?Because

of multidimensional wide range of efficacy of Ayurvedic treatment,

where certain disease conditions or symptoms become refractory to

conventional treatment, a harmonised approach of these two systems of

health care has proven to be successful and fruitful. Sometimes

Ayurveda helps for a synergistic activity while at other places to

antagonise and minmise the toxicity of modern drugs.Q.12 IS AYURVEDA RECOGNISED BY W.H.O?About

20 years back, W.H.O. adopted Traditional Medicine programme in

conjunction with the goal of health for all with the adoption of

primary health care approach. W.H.O. has an open mind on Traditional

Medicine. However, it endorses only that therapy which has solid

scientific evidence with no toxicity. In view of this Ayurveda is duly

recognised by W.H.O.Q.13 DOES AYURVEDIC SYSTEM OF MEDICINE HAVE PLUS POINTS OVER CONVENTIONAL MEDICINAL SYSTEM?Being

holistic and disease eradicative with principles of individualised

treatment, condusive to socio-economic conditions of India and with

availability of abundance of formulations for any particular disease,

use of food items as medicine and lifestyle rules, Ayurveda enjoys a

better place in respect of prevention and cure of the disease is

concerned in comparison to western medical system.Q.14 WHAT IS THE MANPOWER AND INSTITUTIONAL PROFILE OF AYURVEDA IN THE COUNTRY?(i) Number of Registered Medical Practitioners

361881(ii) Number of dispensaries 14252(iii) Number of hospitals 2189(iv) Bed strength 33145(v) Number of teaching institutions(Under Graduate) 187(vi) Number of upgraded Post Graduate Depts.

51(vii) Number of specialities in Post Graduation 16Q.15 WHAT IS REGULATORY MECHANISM FOR AYURVEDIC i.e., EDUCATION AND PRACTICE?The

Central Council of Indian Medicine is a body corporate established

under the provisions of IMCC Act, 1970 to maintain Central Register of

Practitioners of Indian Medicines and for dealing with matters

connected therewith. The Council is responsible for maintaining the

minimum standards of education.This Council as per the provisions in the Act. Introduced the following courses through Regulations.1. Ayurveda Degree Course Ayurvedacharya

(BAMS)2. Ayurveda Post GraduateDegree Course Ayurved Vachaspati (MD Ayurved) 3. Ayurved Varidhi Ph.D AyurvedaQ.16 How should I access Ayurvedic Medicines?Ayurveda

Medicines are being sold in two ways, by practicing Ayurveda doctors

and through retail counters. Again retail counters are of two types-

purely Ayurvedic & secondly alongwith allopathic medicines.

Classical Ayurvedic medicines as mentioned in original texts of

Ayurveda are usually available in former type of counters whereas

patent and proprietary medicines are mainly available in allopathic

chemist shops. Both types of chemists by and large are available in

almost all small and big towns/ cities where from required Ayurveda

medicines can be accessed.Q.17 How do I find a competent Ayurveda practitioner?Any

Ayurveda doctor having such degree/ qualifications as mentioned in

2nd,3rd and 4th schedules of Indian Medicine Central Council Act, 1970

is a recognized medical practitioner. BAMS and MD (Ayurveda) degrees of

new pattern and equivalent qualifications of the time before the

enactment of Central Act are recognized qualifications for the purpose

of registration and practice of Ayurvedic Medicine.Q.18 How safe is to buy Ayurveda Medicines over the counter?Medicines

are safe if the manufacturer is licensed and the label of the container

specifically describes date of manufacturing, expiry date, batch number

of the medicine, dose and indications alongwith ingredients of the

medicine and necessary precaution.Q.19 Can one take Ayurveda Medicine with modern medicines?If

not indicated otherwise by the attending physician, Ayurveda Medicines

can generally be taken alongwith allopathic medicines. Moreover,

Ayurveda Medicines are used as adjuvant to allopathic medicines in most

of chronic and degenerative diseases. As such there is no harm to

consume simple herbal formulations of Ayurveda even without the

prescription of the doctor but mineral based medicines must be used

after due consultation and advice of the doctor. Q.20 What are the common Ayurveda Medicines which can be used without consulting the doctors?Simple

herbal medicines like powders, pills & tablets , syrups and

decoctions can be used for the management of common ailments like

cough, cold, fever, indigestion, vomiting, diarrhea, loss of appetite,

body & joint pains etc, even without the prescription of a doctor.

Similarly, herbal tonics/ health foods can also be consumed if the same

do not create any alarming discomfort or upsets. Q.21 WHEN PHARMACEUTICAL LABORATORY OF INDIAN MEDICINE (PLIM) WAS ESTABLISHED AND WHAT ARE THE FUNCTIONS? Government

of India in 1970 established PLIM as an organisation to monitor the

quality of Ayurveda, Unani and Siddha drugs. This is an apex laboratory

helping to lay down the standards of Ayurvedic medicines. It is the

approved laboratory under the Drugs and Cosmetic Act, 1940. This

laboratory is situated in the CGO Complex at Ghaziabad (U.P.). Q.22 Does any programme for conservation and cultivation of medicinal plants exist in the Govt. Planning?Yes,

various programmes have been launched through Central Assistance for

development and cultivation of medicinal plants. The Reproductive Child

Health Programme (RCH) undertaken by Department of Family Welfare has

an ISM component i.e. ¡Vanaspati Van¢ Scheme for raising medicinal

plants especially of mother and child health importance. This scheme

aims at providing traditional health care through medicinal plants at

the doorstep of rural and tribal population of India, where the

conventional modes of treatment are not available. Moreover, the use of

medicinal plants for medical care is the culture bound practice of

Indian Society especially rural one. The Department of Indian System of

Medicine provides Financial Assistance to various

Government/Semi-Government institutes under the control of

Centre/State/UT governments to propagate cultivation and development of

medicinal plants, Department of Biotechnology imparts financial

assistance for Biodiversity conservation projects including

cultivation, post harvest processing and storage of medicinal sources.

Similarly Department of Forests is also engaged in such activities.Q.23 What

is Government doing for endangered Indian species of Medicinal Plants

used in various formulations of Ayurveda, Unani, Siddha and Homoeopathy?Threatened

or endangered or vulnerable medicinal plants species are being

attempted to be protected in various ways. In situ and Ex situ

conservation, development of Agro-techniques for cultivation of plants

of medicinal importance for commercial use, banning export of

endangered species or their extracts or products made therefrom and

encouraging the farmers for propagation and cultivation of commercially

viable medicinal plants are, some of the very important steps taken by

the Government to preserve the Indian species and to make these

available for sustainable use. Restrictions are imposed for rampant

deforestation and collection of raw materials of medicinal importance

from the wild sources.Q.24 How

is India¢s traditional knowledge on medicinal plants going to be

protected and what is being done to avoid patents on Indian medicinal

plants?As

per International Patent Classification (IPC) non-patent literature

sources are many and diverse as compared to patent literature which is

usually wholly contained in several distinctive databases. The

situation when patent literature being easy searchable and available

resources of non-patent literature sources very wanting leads to wrong

granting of patent rights to newly claimed subject mater, especially

patents on medicinal plants/plant products. In order to address the

need of having easily accessible non-patent literature data base

pertaining to traditional knowledge of uses of medicinal

plants/medicinal plant based products or formulations, the concept of

Traditional knowledge Digital Library (TKDL) is in the process of

creation. This TKDL put to use will have a dual role to contribute in

avoidance of grant of patents, firstly being productive in nature it

will provide readily the information to examiners of patents during the

examination process for grant of patent and secondly it being reactive

in nature, can be utilised at a time of opposition proceedings for

avoiding a patent on a traditional knowledge based claim.Q.25 What are the future potential programmes of Department of ISM & H?Medicinal

Plant Board, essential drug list of Ayurveda, National Ayurvedic

Hospital, induction of ISM component in major Allopathic hospitals and

setting up Panchkarma and Kshar sutra therapy units in State level and

Central Government hospitals are some of the prime issues to be

instrumental in the propagation of departmental activities of ISM & H.¡Medicinal

Plant Board¢ will take care of conservation and cultivation for

sustainable use of medicinal plants from administrative and technical

angles. Department of ISM & H would be the nodal agency for its

operation in interface mainly with Ministry of Environment and Forests,

Ministry of Agriculture, Department of Bio-technology, Department of

Commerce and Ministry of Law.Q.26 What are the main Rasayana (Immuno-modular) Medicines of Ayurveda?Ashavgandha

(Withania somnifera), Guduchi (Tinospora cordifolia), Amla (Emblica

officinalis), Haritaki (Terminalia chebula), Shilajeet (Black bitumen

or Mineral pitch), Suvarn Bhasm (incinerated Gold with herbal

excipients) are very potent Rasayana medicines, prescribed judiciously

in somatic degenerative disease conditions for immuno-modulation and

and adaptogenic effects. Mandookparni (Bacopa Monieri), Mulethi

(Glycirrhiza glabra), Guduchi (Tinospora cordifolia) and Shankhapushpi

(Convolvulus Plenricaulis) are from main Psychomodular Rasayanas used

extensively in mental disorders and for improving higher mental

functions like concentration, retention and memory, Vijaysara

(Pterocaspus marsupium) for Diabetes Mellitus, Katuka (Picrosshiza

kurco) for liver disorders Vidang (Abies Webiana) for Hoelminthic

induced Gasto intestinal problem, Bakuchi (Psorylia Corylifolia) for

Leucoderma Bhallatak (Semecarpur anacardium) for piles and autoimmune

disorders), Shirees (Albizzia Lebek) fr allergic conditions), Vacha

(Acorus clamus) for speech disorders, haldi (Curcuma Longa) for

urinary, allergic and septic problems, Neem (Melia Azadiracta) and

Khadir (Acacia Catechu) for skin problems and Chirayata (swertia

chirayata) for febrile disorders are some of the other Rasayana

Medicines for disease-wise use.Apart

from the above mentioned medicines there is an eleborate code of

conduct described in the classical text for achieving rejuvenation and

maintaining youthfulness.Q.27 What are the aphrodisiacs/Sexual Tonics for improving the quality of semen/sperm count and motility and fertility?Musli,

Kaunch, Shatavari, Gokshur, Ashavgandha, Utangan, Salmpanja, Vidari,

Vijaya, urd, Bhautak, Akarkara, Abhrak Bhasm, trivang Bhasm, Makardhvaj

are some of the Vajikarana medicines which on judicious use and

adoption or specific do¢s and don¢ts of diet, definitely give a desired

result.Q.28 Is there any regulation for manufacturing Ayurvedic Medicines?Yes,

there exists such a regulation bywhich commercial manufacturing of

Ayurvedic medicines is regulated. Manufacturers have to take prior

license from the State Drug Controlling Authority for running an

Ayurvedic Pharmacy. Formulations whether classical or patent

proprietary have to be got cleared from the competent authority before

starting commercial manufacturing.Q.29 Is there any code of conduct for good manufacturing practices (GMP) in Ayurvedic Pharmacies?Till

date there was no provision/regulatory binding for ensuring good

manufacturing of Ayurvedic medicines. Imposition of GMP through an

amendment in the current licensing procedures has been implemented

w.e.f. 23-6-2000. This will not only pose stringent guidelines for

having standard hygienic conditions in the pharmacy, but will also help

in improving the quality of medicinal products.Q.30 What is Herbal Tea?In

fact, herbal tea is a misnomer, which confuses the consumer that it is

a sort of tea made of tea leaves and other herbal ingredients.

Actually, Herbal Tea is a combination of certain medicinal herb

components devoid of tea leaves, which on boiling gives a palatable

decoction and can be used as an alternative to conventional tea. In

accordance to the composition the so called herbal tea has appetizing,

antacid, soothing, antitussive, anti common cold and anti pyretic

effects.Best Regards Mohammad BashaarFrom: Anand Chaudhary <ayurasabhaishja@...>Subject: Safety and Efficacy of Ayurvedic Formulationsnetrum Date: Saturday, January 10, 2009, 2:22 PM

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 ChaudharyAssociate ProfessorDeptt of Rasa Shastra(Ayurvedic Pharmaceutics)

Faculty of AyuvedaInstitute of Medical Sciences Banaras Hindu UniversityVARANASI 221005Cell 945207448098898638660542-2366900( R)