Scientific Basis for Ayurvedic Therapies -1

Scientific Basis for

Ayurvedic Therapies 

edited by

Brahmasree Lakshmi Chandra Mishra

This   contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with

permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish

reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials

or for the consequences of their use.

There has been increasing public interest in complementary alternative medicine during

the past decade in the U.S. that led to the establishment of the Center for Alternative and

Complementary Medicine at the National Institutes of Health (NIH), Bethesda, MD, by

the U.S. Congress to conduct scientific evaluation of these therapies. The Ayurvedic system

of medicine (traditional medical system of India) is recognized by NIH as a complementary

and alternative medicine (CAM). Ayurveda has been practiced in India for over 5000 years

and is recognized as a complete medical system comparable with allopathic medicine by

the government of India. In India, Ayurveda has a complete infrastructure, medical colleges,

hospitals integrated with allopathic medicine, research institutes, and scientific

journals devoted to Ayurveda. In addition, India’s Ayurvedic pharmaceutical industry is

governed by the same food and drug laws that regulate conventional drugs. Research in

pharmacology, biochemistry, phytochemistry, and clinical trials of Ayurvedic therapies

currently constitutes a substantial portion of the total research conducted in government

institutes and medical colleges in India.

There has been considerable scientific research effort in Ayurvedic therapies during the

past 50 years. This research has not been adequately disseminated to Ayurvedic students

and physicians. In order to accomplish the assimilation of this research into practice, three

major goals were set for this book: (1) to provide information on pharmacological, biochemical,

and clinical investigations on Ayurvedic therapies; (2) to explore the scientific

basis of Ayurvedic concepts of diseases, diagnosis, and treatments; and (3) to develop new

interpretation of Ayurvedic concepts of therapies based on modern knowledge where

possible.

As editor of the book, I used my combination of medical education in Ayurveda and

research experience in conventional medicinal pharmacy and pharmacology in developing

this text. Disease topics were carefully selected based on the scientific studies available

and the prevalence of a disease. Knowledgeable physicians and scientists in these fields

were selected based on their scientific contributions in the field to review and evaluate

the worldwide literature. In addition, I, along with one Ayurvedic physician, one biochemist,

and one overall expert with knowledge in conventional and CAM research

methods, read each chapter.

General topics such as Ayurvedic disease management,

panchakarma

, Ayurvedic

bhasmas

,

the current status of Ayurveda in India, and clinical research design and evaluation of

typical clinical trials of certain diseases were written by experts in their fields.

It is my hope that the book will prove useful to all Ayurvedic and conventional medicine

physicians, students and scientists, and the general public. In addition, the book is

expected to bring awareness to the community of health-care providers that Ayurveda is

significantly more than a few home remedies, yoga, and meditation. It is a fully established

system of medicine, has a considerable scientific base, and has therapies that can be used

alone or as an adjuvant with conventional health care as practiced in India.

 .

Lakshmi Chandra Mishra

Editor

Lakshmi Chandra Mishra, Ph.D.,

is a professor in the

Research Division of Southern California University of

Health Sciences and an Ayurvedic medicine practitioner

at the University Health Center, Southern California University,

Whittier. He has been conducting research on

Ayurvedic therapies for musculoskeletal disorders at the

university, and stroke in collaboration with faculty at the

University of Southern California, School of Pharmacy.

Dr. Mishra received his Bachelor of Indian Medicine

and Surgery degree from Bundelkand Ayurvedic College,

Jhansi, UP, India, in 1954 and practiced Ayurvedic

medicine for several years thereafter. He received his

bachelor’s and master’s degrees in pharmacy from

Banaras Hindu University, Varanasi, UP, India, in 1958

and 1959, respectively. He conducted phytochemical and

pharmacognostical studies on an Ayurvedic herb for his master’s degree thesis. After

getting his pharmacy degrees, he worked as a pharmaceutical chemist at the Hindustan

Antibiotics Ltd., Pimpari Poona, for 1 year and then as an assistant professor of pharmacology

at Maulana Azad Medical College, New Delhi.

After coming to the U.S. in 1963, Dr. Mishra received his Ph.D. in biochemical pharmacology

from the State University of New York at Buffalo in 1967. Dr. Mishra worked on

cancer chemotherapy research at Roswell Park Memorial Institute in Buffalo for 1 year

before joining Microbiological Associates, Bethesda, MD, where he conducted research on

anticancer agents that was sponsored by the National Cancer Institute, National Institutes

of Health (NIH), Bethesda, MD. He later worked for several federal regulatory government

agencies as a pharmacologtist, toxicologist, and branch chief. Dr. Mishra has served on

many scientific committees in government and industry. He was an ex-officio member of

the National Cancer Advisory Board of the National Cancer Institute, NIH, for 18 years.

Dr. Mishra has extensive background and experience both as a clinician in the traditional

and modern practice of Ayurveda and as a bench scientist. His research expertise includes

pharmacology, toxicology, pharmaceutical chemistry, pharmacognosy, and phytochemistry.

He has authored more than 100 scientific papers, documents, and reports in the fields

of Ayurvedic medicine, pharmacology, toxicology, cancer chemotherapy, and health risk

assessment, particularly cancer and neurotoxicity risk for exposure to environmental

pollutants.

Introduction

The objective of this book is to explore a scientific basis for Ayurvedic medicine and create

a better understanding of Ayurveda among health-care providers and consumers. Books

published in the West on Ayurveda generally discuss only a few aspects of Ayurveda such

as dietary and lifestyle changes, yoga, breathing exercises, meditation practices, and

aroma, gem-stones, color, music therapy, herbs, and other therapies. In fact, these areas

cover only a small fraction of the body of classical Ayurveda. These areas offer little or

no information about current biochemical, pharmacological, and clinical investigations.

During the past 100 years, several hundred Ayurvedic herbs have been investigated with

respect to plant chemistry, active chemical constituents, pharmacological effects, safety,

and efficacy. However, the basic research on Ayurvedic therapeutic agents has not been

adequately integrated into disease management protocols available to most consumers in

the West.

The origin of Ayurveda is traced back to four books of knowledge called

vedas

:

Rigveda,

Samveda, Yjurveda

, and

Atharveda

(4500 to 1600

B

.

C

.). The information on health care was

subsequently developed by many Ayurvedic practitioners and finally compiled into three

important books known in Ayurveda as the senior triad (

vriddha traya

):

Charak Samhita

,

Sushrut Samhita,

and

Ashtang Hridaya Samhita.

The subsequent three books that are commentaries

on the senior triads are known as the junior triad (

laghu traya

):

Madhava-nidana,

Sarangdhar Samhita,

and

Bhavaprakash Nighantu

. These books contain basic concepts of

health and disease, disease management, anatomy and physiology, hygiene, materia medica,

pharmacology and therapeutics, herbal formulations, pharmacy, and synthesis of

herbo-mineral formulas. Diseases are classified according to organ systems and functions.

Specialties such as internal medicine, surgery, pediatrics, gynecology, obstetrics, eye, ear,

nose, and throat diseases, geriatrics, eugenics and aphrodisiacs, psychiatry, pharmacology,

toxicology, and pharmacy are clearly delineated and discussed in detail in Ayurveda.

1

Although there is no record of pharmacological testing during the time period when

Ayurvedic texts were written, 50 distinct pharmacological categories of medicinal plants

were described. The categories include anti-inflammatory, analgesic, antiallergic, antihistaminic,

antidiuretic, diuretic, antiemetic, emetic, purgative, astringent, antiasthmatic,

antipyretic, and others.

2

Similar to conventional medicine, Ayurvedic medicine has also

benefited from advances in science and technology. These advances facilitated the understanding

of diseases, the development of better pharmaceutical products, and the implementation

of diagnostic techniques. Scientific studies in laboratory animals have now

confirmed the pharmacological properties of many Ayurvedic herbs. The old concept of

accepting the last word of an Ayurvedic teacher without questioning the scientific underpinning

has begun to disappear. A large number of medical schools and medical research

institutions, both private and governmental, are currently involved in Ayurvedic research.

The government of India has established an agency, the Central Council for Research in

Ayurveda and Siddha (CCRAS) under the Ministry of Health and Family Welfare, to

sponsor and conduct research in Ayurveda. The agency has been conducting and sponsoring

Ayurvedic research all over India for more than 30 years in 70 regional Ayurvedic

research institutions. The agency is conducting clinical trials to investigate the effectiveness

of Ayurvedic products as well as basic research. Some of the clinical trials conducted by

© 2004 by CRC Press LLC

Review on Five Diagnosis Categories.” The basic research includes pharmacology, biochemistry,

plant chemistry, product development, the cultivation of medicinal plants, and

manufacturing practices for safe and effective Ayurvedic products.

Basic Concept

Whereas conventional medicine is primarily oriented toward the treatment of disease,

Ayurvedic medicine is oriented toward prevention, health maintenance, and treatment.

In conventional medicine, drugs are developed based on the concept that the elimination

of specific causes of a disease, such as microorganisms, will cure a disease. On the other

hand, the belief in Ayurvedic medicine is that a disease is the product of an imbalance in

the body and mental elements that reduce the body’s resistance to diseases. If the imbalance

is corrected and the body’s defense mechanisms are strengthened by herbal formulas,

lifestyle changes, and diet, then the body will resist a disease with a goal of eliminating

it. Herbal and herbomineral products regularly used in Ayurveda are believed to

strengthen the body’s defenses. Scientific evidence is gradually developing in support of

the Ayurvedic concept.

3

Ayurvedic Physician

Scientific, technical, and engineering advances in the 20th century have been extraordinary.

They created an explosion of new information and understanding in molecular biology,

biochemistry, physiology, antibiotics, vaccines, genetics, mapping of genome, and the

identification of genes responsible for inherited diseases. Ayurvedic physicians have also

benefited from these new medical advances. Scientifically based information is the core

of the preclinical, clinical, residency, and continuing medical education phases of training.

An Ayurvedic physician must be able to understand and appreciate new scientific

knowledge in order to maximize the benefits of Ayurvedic therapies. In order to do so,

an Ayurvedic physician must be aware of the current information on the disease processes,

inter- and intracellular message transmission, membrane transport, protein interactions,

chemical and microbial toxins, autoimmunity, cellular and humoral immunity, and

dynamics of neurotransmitters. A physician needs to know about genetics, congenital

inborn metabolic problems, pharmacological and biochemical research, and the use of

various clinical chemistry data in diagnosis and monitoring disease processes in order to

interpret the clinical data. He must understand the basic principles of toxicology and how

the knowledge can be used in developing protocols for clinical studies. He must also know

how to apply basic science to the Ayurvedic concept of disease management and the use

of modern diagnostic methods involving urine and blood chemistry, enzyme assays,

histology, pathology, radiology, etc. Finally, the Ayurvedic physician must understand the

interaction of spiritual and psychological elements of patients as described in Ayurveda

and be able to earn the patient’s trust through compassionate and holistic care.

the agency are discussed in Chapter 3, “Clinical Research Design: Limited Systematic

© 2004 by CRC Press LLC

Educational Standards

An Internet search revealed a dozen Ayurvedic colleges in the U.S. offering weekend

courses ranging from 1 to 3 years. The curriculums are designed to familiarize students

with Ayurvedic therapies, but are inadequate for actual clinical practice. Because Ayurveda

is currently unregulated in the U.S., there are no standards to meet or pass any state

examination. Because herbs or herbominerals are included under the U.S. Dietary Supplement

Health and Education Act (U.S. DSHEA, 1994), Ayurvedic practitioners in the

U.S. recommend herbal formulas as dietary supplements along with dietary changes, yoga,

and breathing exercises to help remedy certain health problems.

Ayurveda has been recognized as an independent medical system by the government

of India for a long time. The Central Council of Indian Medicine (CCIM), Ministry of

Health (Regulations 1986, Minimum Education in Indian Medicine) regulates Ayurvedic

education and training in India.

4

The curriculum includes 2820 hours of theory and 780

hours of practical and laboratory work over a period of 54 months; this is followed by 1

year of residency leading to a Bachelor of Ayurvedic Medicine and Surgery,

5

formerly

Bachelor of Indian Medicine and Surgery. This is an integrated program that teaches

Ayurvedic and alopathic courses so that therapeutic options for patients may be maximized.

Reasons for the Current Interest in Ayurveda

The great therapeutic success of synthetic antibiotics, hormones, and vaccines has created

an expectation that conventional medicine will be able to discover a cure for every ailment.

This expectation has been only minimally met for many diseases (e.g., cancer, arthritis,

autoimmune diseases, and AIDS) even after spending hundreds of billions of dollars in

research worldwide over the past 30 years. In addition, the synthetic antibiotics and

steroids sometimes result in serious adverse effects, such as immunosuppression, gastrointestinal

bleeding, and ulcers, after prolonged administration. Ayurvedic therapies

generally provide relief without such adverse effects even after prolonged administration.

Some formulas known as

rasayanas

are believed to improve the body’s defense mechanisms.

For example, in one short study for 90 days with

chyawanprash

, a

rasayana

, the

following improvements were observed: increased stress tolerance; improved endocrine

functions (adrenal and testicular); positive nitrogen balance as indicated by increased

serum protein level; and a decrease in urinary levels of nitrogen, creatinine, mucopolysaccharide,

and hydroxyproline. The general well-being of the volunteers improved and none

of them complained of any physical disorder.

3

Ayurvedic herbs and formulas often have a wide spectrum of therapeutic activity. For

example,

guggul

is recommended in Ayurveda for 25 or more ailments (e.g., inflammatory

diseases, a variety of infections, muscle spasm, cough, bronchitis, anemia, endometritis,

neurological diseases, skin diseases, urinary system disorders, obesity, osteoarthritis, and

rheumatoid arthritis). The reason for this wide spectrum of activity is that

guggul

has antiinflammatory,

anticoagulant, hypolipidemic, and antibacterial activity; it can be beneficial

in many health ailments associated with inflammation, infection, obesity, or blood clotting.

Additionally, pharmacological activities of herbs may not be confined to one specific

chemical constituent.

Guggul

was found to have anti-inflammatory activity in both polar

© 2004 by CRC Press LLC

and nonpolar solvents, indicating that several chemical constituents present in it may have

anti-inflammatory activity.

5

Similarly, herbs showing neuropharmacological activity

in

vitro

did not have the activity concentrated in any one solvent extract. This indicates that

several constituents with different chemical physical properties may have the same neuropharmacological

activity.

6

Ayurvedic therapies are known to be relatively economic. For example, a 1-month dose

of an Ayurvedic formula for arthritis may be obtained at this time for about $20, which

is often the co-payment for brand name prescription drugs for many health insurance and

health maintenance organizations. Other alternative nondrug complementary therapies

may be even more expensive.

The relative safety of Ayurvedic medicine is another reason for its popularity. Ayurvedic

formulas are time tested for safety. These formulas contain vitamins; minerals; biologically

active steroids, alkaloids, glycosides, and tannins; and a variety of antioxidants in a natural

state. A single herb extract or a pure active chemical constituent may cause some adverse

effects under certain conditions and dose levels. For example,

guggul

extract has been

shown to produce some anticoagulant effect under certain conditions.

7,8

Ayurvedic text

formulas containing

guggul

may be safer than the

guggul

extract; the formulas that have

guggul

in relatively small amounts, along with many other herbs, act as synergists and

possibly counteract some of the side effects.

Quality of Ayurvedic Formulas

In order to assure quality of Ayurvedic formulas, the government of India, Ministry of

Health, amended the Drugs and Cosmetic Act of 1940 in 1964 to include Ayurvedic drugs

(Ayurvedic herbs and herbal formulas). The Act requires the raw materials to be genuine

and adequately identified; the formulas must contain ingredients listed on the label and

manufacturing must be conducted under prescribed good manufacturing practices conditions.

CCRAS developed a formulary of Ayurvedic text formulas called

The Ayurvedic

Formulary of India

published in 1978. CCRAS conducted research to establish enforceable

standards for Ayurvedic formulas similar to allopathic drugs and promulgated the standards.

The book

Pharamcopoeial Standards of Ayurvedic Formulations

was first published in

1976 and subsequently revised in 1987. This effort was followed by the development of

The Ayurvedic Pharmacopoeia of India

in 1989. The pharmacopoeia contains the popular

names; macroscopic and microscopic description of herbs; and limits for foreign matter,

total ash, acid-insoluble ash, alcohol-soluble extractive, water-soluble extractive, and

heavy metals in the same way as prescribed in allopathic pharmacopoeias. It also gives

the levels of known chemical constituents, therapeutic uses, and doses.

Organization of the Book

Only a few diseases are selected based on the scientific data available on Ayurvedic

therapies. Specialists in treating each disease searched the worldwide literature, critically

reviewed the information on the basis of their expertise, and summarized the information

in an understandable and easily usable form. Ayurvedic description and therapy of a

disease are first described followed by a discussion using current knowledge. Available

at  

pharmacological, biochemical, and chemical studies on herbs used in the management of

the disease are evaluated to determine if there is an adequate scientific basis for their use.

Finally, the overall management strategy of the disease, commonly used therapies, and

scientific data are presented.

An attempt is made to first use the English translation or meaning of the Ayurvedic

word, followed by the Ayurvedic word in parentheses as often as possible to make the

chapters easy to read and understand. In addition, a list of Ayurvedic words is provided

and addresses of the manufacturers of Ayurvedic formulas, and a list of journals publishing

articles on Ayurvedic therapies. The words

Ayurvedic texts

or

Ayurveda

refer to the

senior and junior triads in all chapters.

The book is organized to give a global picture of Ayurveda and to show that these

therapies are relatively safe, effective, and have supporting scientific data. It is intended

to provide better understanding of Ayurvedic medicine so that wherever appropriate, the

integration of these therapies by the health-care providers may become possible.

References

1. Mishra, L., Singh, B.B., and Dagenais, S., Ayurveda: a historical perspective and principles of

the traditional healthcare system in India,

Altern. Ther. Health Med

., 7(2), 36–42, 2001a.

2. Mishra, L., Singh, B.B., and Dagenais, S., Healthcare and disease management in Ayurveda,

Altern. Ther. Health Med

., 7(2), 44–50, 2001b.

3. Udupa, K.N. and Singh, R.H.,

Clinical & Experimental Studies on Rasayana Drugs and Panchkarma

Therapy

(monograph), Central Council for Research in Ayurveda and Siddha, New Delhi,

India, 1993.

4. Central Council of Indian Medicine (Minimum Standards of Education in Indian Medicine)

Regulations, 1986, New Delhi-110055, 13 July, 1989, in

Abstracts of the Gazette of India

, Part III,

Section 4, August 5, 1989.

5. Gujral, M.L., Sareen, K., Tangri, K.K., Amma, M.K.P., and Roy, A.K., Anti-arthritic and antiinflammatory

activity of gum (balsamodendrone mukul hook),

Indian J. Physiol. Pharmacol.

, 4,

267–273, 1960.

6. Misra, R., Modern drug development from traditional medicinal plants using radioligand

receptor-binding assays,

Med. Res. Rev

., 18(6), 383–402, 1998.

7. Bordia, A. and Chuttani, S.K., Effect of gum guggulu on fibrolysis and platelet adhesiveness

in coronary heart disease,

Indian J. Med. Res.

, 70, 992-996, 1979.

8. Mester, L., Mester, M., and Nityanand, S., Inhibition of platelet aggregation by “guggulu”

steroids,

Planta Med.,

37, 367–369, 1979.

1.1 Introduction

It is a universally accepted fact that good health plays an important role in human

development. According to the concepts of Ayurveda, good health is based on the equilibrium

of

dosha

(humor),

agni

(digestive fire),

dhatu

(seven body tissues: lymph, blood,

muscle, adipose tissue, bone, bone marrow, semen), and

mala

(feces, urine, and other waste

products). Furthermore, in Ayurveda there is clear-cut emphasis on maintaining physical,

mental, and spiritual well-being as part of good health.

1

The World Health Organization

(WHO) defines good health as a state of complete physical, mental, and social well-being

and not merely an absence of disease or infirmity,

2

which is in close approximity to the

definition of good health mentioned in Ayurvedic classics. Creation of the infrastructure,

generation of requisite human resources, and framing of appropriate policies required to

meet the health-care needs of its citizens are accepted as some of the main and fundamental

responsibilities of a modern state. Every country in the global fraternity aspires to meet

the health-care needs of its people through an appropriate and cost-effective approach.

CONTENTS

© 2004 by CRC Press LLC

2

Scientific Basis for Ayurvedic Therapies

The contributions of Traditional Systems of Medicine (TSM) for global health care in

the past and their importance for the health-care needs of the present and the future are

well recognized. The traditional systems of India, which are now called Indian Systems

of Medicine (ISM), have a very strong conceptual base and have been practiced uninterruptedly

for a very long time; hence they are considered as independent medical systems.

Ayurveda, Siddha, and Unani are the three important traditional systems practiced in

India. Ayurveda is the oldest and the most widely practiced system among the three. It

takes into consideration all aspects of health including mental, physical, and social components.

Considering the comprehensive manner in which all matters related to health are

addressed in Ayurveda, it has potential to become a global medical system. However, to

achieve this status, some of the shortfalls that are perceived to hinder its progress must

be rectified. In the following pages the present status in different subsectors of Ayurveda

are reviewed and some of the steps required for further development in the future are

suggested.

The matters that require consideration are national policy for the development of

Ayurveda in India; role of Ayurveda in the country’s health-care delivery; regulatory

mechanism to control and regulate manufacturing and utilization of the drugs manufactured

in this sector; and facilities available for the generation of trained manpower, including

clinical and paramedical personnel, research and development aspects, and

globalization of the system.

1.2 National Policy on ISM in India

One of the most important requirements for any system to play a meaningful role in the

health care of a country is for that system to receive due recognition from the government.

In India, the highest policymaking body regarding the matters concerned with health and

family welfare is the Central Council for Health and Family Welfare, set up under Article

226 of the constitution of India. It consists of central health ministers, state health ministers,

eminent health experts, nongovernmental organizations with an interest in the health

sector, and officials of the central and state governments. It strongly advocates systematic

use of the ISM in the primary and secondary infrastructure. In its last meeting, the Council

recommended that at least one physician from the ISM and Homeopathy (ISM & H) should

be available in every primary health center. Further, it was also resolved to introduce

systems in the existing state and district level government hospitals.

The government of India has taken up the matter quite seriously and drafted a national

3

provides comprehensive coverage of different sectors. Feedback and suggestions have

been collected from concerned organizations. This will form the basic material to frame

the National Policy after completing the process of consulting different state governments

and different ministries of government of India. Some highlights of the draft policy are

as follows:

• It addresses the system in the areas of current relevance while at the same time

delineating the immense opportunities that lay ahead.

policy on traditional systems practiced in India (www.indianmedicine.nic.in). The policy

special treatment centers for ISM & H in rural hospitals and to create a wing for these

© 2004 by CRC Press LLC

Ayurveda — A Potential Global Medical System

3

• It plans to build upon the positive features of ISM & H, which are their modest

cost, low level of technological input, and growing popularity. There is a possibility

of expansion of activity in a wide range of related fields. To maximize

utilization of this opportunity a range of strategies has been recommended.

• It seeks to revamp the curriculum of the educational institutes to reorient the

approach of the practitioners of these systems to increase their relevance, credibility,

and professionalism.

• It strongly advocates enforcement of good manufacturing practices (GMP) by

placing acceptable levels of regulation and enforcement covering manufacture

and certification of drugs.

• Several measures have been mentioned for the scientific and sustainable utilization

of the medicinal plant-based resources of the country. It advocates adoption

of a collaborative approach. Emphasis has been placed on utilizing the experience

and scientific base available in the research councils of the country; for example,

the Central Council for Scientific and Industrial Research (CSIR), the Indian Council

for Agriculture Research (ICAR), and institutes under the Department of Science

and Technology.

• To protect the intellectual property rights (IPR) of the resources of this sector,

creation of an extensive database and a traditional knowledge digital library

(TKDL) has been advocated.

• It also highlights the importance of utilization of local health traditions in the

national health-care programs. It seeks to provide support of the operational

research studies and efficacy trials for this purpose.

• The policy encourages propagation of Ayurveda and other ISM throughout the

world, especially in areas where there is special interest in these systems, through

Indian missions abroad. This policy will promote creation of a larger constituency

for the practitioners of these systems. Promoting ISM as part of health tourism is

being planned. Other approaches include international collaboration and academic

exchange between interested groups.

• It has been strongly recommended that there should be an increase in the share

of ISM in the national health budget.

• The policy also seeks to involve and promote the importance of ISM physicians

in various national health programs.

• It seeks to establish and build the credibility of the ISM sector by encouraging

certification and establishment of quality marking of products to allay the concern

expressed in some quarters about the quality, safety, and efficacy of the products

used.

• It recommends effecting policy changes to cover nutraceuticals and food supplements.

The Drugs and Cosmetic Act would be amended to cover intermediates

and partially processed plant-based products. The enactment of the ISM Product

Information Promotion and Regulation Act is under consideration.

• There will be policy support and taxation incentives to promote high standards

of manufacture.

• It seeks to support evidence-based research to determine the efficacy of ISM drugs

and therapies, generation of data on safety and efficacy, along with standardization.

• There will be strong encouragement for undertaking research on basic principles

of Ayurveda and the medico-historical approach.

Scientific Basis for Ayurvedic Therapies

There is a feeling that formulation of a national policy has been delayed inordinately;

however, the fact that a comprehensive draft has been prepared and is being circulated

among all the agencies involved in its implementation indicates that the matter has been

taken seriously and there will be a discernible change in the Ayurvedic sector for the better

in the future. The fact that such a detailed draft policy has been prepared and the government

of India has initiated steps to enforce GMP in the ISM drug-manufacturing sector

clearly indicates that it is earnest in its desire to develop and ensure mainstreaming of the

ISM sector and its practitioners. The expenditure in this sector has gradually and significantly

increased from Rs. 21683.60 million (US $433.66 million) in 1996–1997 to Rs.

40792.60 million (US $815.95 million) in 2000–2001.

1.3 Role of Ayurveda in India’s Health Care

Ayurveda is quite popular, being practiced throughout the country including tribal and

remote areas where other modes of therapies are not readily available. Though it does not

have as an elaborate organized structure as its modern counterpart, it plays a major role

in meeting the health-care needs of a large section of India. There are separate directorates

of the ISM & H in 18 states. Though Ayurveda is popular in all these states, this system

is more prevalent in the states of Kerala, Himachal Pradesh, Gujarat, Karnataka, Madhya

is prevalent.

At present there are 611,413 practitioners of TSM, 26,032 hospitals/dispensaries, and

approximately 8,500 Ayurvedic drug manufacturers in the country. There are more than

190 Ayurvedic colleges turning out more than 7,000 Ayurvedic graduates and around 700

the resources and is taking steps to integrate ISM in primary health care and national

health programs. This growing attitude change is demonstrated by the drafted national

policy mentioned above.

1.4 Academic Role of Ayurveda in Future Health Care

The concepts of proper lifestyles, dietary habits, and daily and seasonal routines followed

in Ayurveda can be adopted with suitable modification to different countries in different

TABLE 1.1

Summary of Medical Care, Medical Manpower, and Facilities Available under ISM as of 1 April

1999

Facilities Ayurveda Unani Siddha Yoga Naturopathy Homeopathy Total

Hospitals 2,258 196 224 8 21 297 3,004

Beds 40,313 4,872 1,811 101 733 12,836 60,666

Dispensaries 14,416 970 363 42 56 7,155 23,028

Registered

practitioners

367,528 41,221 12,915 — 388 189,361 611,413

postgraduates every year (Tables 1.1 and 1.2). The government of India is well aware of

Pradesh, Rajasthan, Uttar Pradesh, and Orissa. In the state of Tamilnadu the Siddha system

Ayurveda — A Potential Global Medical System

parts of the globe after giving due consideration to the cultural milieu existing in each

country and also the constitutional profile of each population. Attempts can also be made

to utilize the medicinal plant resources of these countries for meeting the health-care needs

of their people after categorization of the plants according to Ayurvedic concepts. Drugs

used in ISM can be used as adjuvant to the main drugs used in conventional medicine.

Therapeutic approaches such as

Panchakarma

,

Ksarasutra,

etc. can certainly be integrated

into other health systems, broadening the choices available to physicians and patients.

1.5 Education and Training

At present, more than 190 undergraduate Ayurvedic colleges in India offer a curriculum

for a Bachelor of Ayurvedic Medicine and Surgery (BAMS) degree. This program takes

5

1

/

2

years to complete and runs according to the standards of the Central Council of Indian

Medicine (CCIM), which is a statutory body that regulates the ISM education in the

country. During the 5

1

/

2

years of education, the student must go through internship for

a period of 1 year. The 10 + 2 (10 years of school education followed by 2 years of predegree

study) students with Science Group are eligible to take admissions in the degree course.

This is similar to the requirement for the admission to the MBBS (allopathy) degree

program. In fact, in many states there is a common entrance test to admit candidates to

these courses. BAMS contains many modern subjects in its course material; however,

nothing is taught in MBBS colleges about Ayurveda or any other ISM. This is a paradox,

as many modern medicine graduates prescribe Ayurvedic drugs — especially in difficultto-

cure diseases like hepatitis — without any training in Ayurveda. The Department of

ISM, being perceptive of this situation, has prepared course material containing basic

concepts and fundamentals of ISM & H for incorporation in MBBS curricula. This has

been forwarded to the Medical Council of India for appropriate action. In most states,

e.g., Uttar Pradesh, Rajasthan, and Gujarat, Ayurvedic colleges are state supported.

Because it is necessary that Ayurvedic graduates understand modern advances in medical

diagnostic methods, medical technology, and drug treatment, the present curriculum

contains about 50% conventional medicine, and clinical and preclinical subjects. The

CCIM, which is the apex body in matters related to the education and practice of Ayurveda

in the country, is initiating steps to revise the curriculum to suit the present-day requirement

by placing emphasis on practical-oriented teaching. Furthermore, at present there

is no facility to impart training in some of the important disciplines, like

Vriksha

Ayurveda

(a subdivision of Ayurveda that deals with matters related to cultivation of plants) and

Pasu

Ayurveda (Ayurvedic veterinary science), at the undergraduate level. Steps have to

be initiated to include them as subjects for study at the undergraduate level.

TABLE 1.2

Number of Undergraduate and Postgraduate Colleges and Institutions In India (1 April

1999)

Facilities Ayurveda Unani Siddha Total

Undergraduate colleges 196 40 2 238

Admission capacity 7070 1280 150 8500

Postgraduate colleges 49 3 2 54

Admission capacity 645 35 70 750

Source: www.indianmedicine.nac.in-; Annual Report 2000–2001.

© 2004 by CRC Press LLC

6

Scientific Basis for Ayurvedic Therapies

1.5.1 Postgraduate Education

Postgraduate education is available in over 30 research institutes and offers specialization

in 16 clinical and preclinical Ayurvedic specialty areas such as medicine, surgery, pediatrics,

pharmacology, pathology, pharmacy, and

Rasa Vigyan

. Besides the mainstream institutes,

the National Academy of Ayurveda, run by the government of India, was established

to impart intensive training in different specialties for graduates and postgraduates of

Ayurveda under the guidance of eminent scholars (similar to the traditional custom of

Guru Shishya

Parampara; interested readers can obtain more information from the Web

site of the Department of ISM as well as a CD released by the department

3–5

).

At the present time, Gujarat Ayurvedic University is the only university exclusively

devoted to Ayurveda and allied sciences in India. Its constituent institutes include the (1)

Institute for Postgraduate Training and Research in Ayurveda financed by the government

of India, (2) Shri Gulabkunverba Mahavidyalaya funded by the Gujarat State, (3) Institute

of Ayurvedic Pharmaceutical Sciences, (4) Institute of Ayurvedic Medicinal Plant Sciences,

(5) International Center for Ayurvedic Studies, and (6) Mahrishi Pananjali Institute for

Yoga and Naturopathy Education and Research. The last three institutes are self-financed.

The Gujarat Ayurvedic University has signed the Memorandum of Understanding (MOU)

with nine Ayurvedic institutions functioning in Japan, Australia, the Netherlands, Italy,

Argentina, and Germany to coordinate and facilitate the globalization of Ayurveda

through academic collaboration. Earlier, Medical (Ayu) Institute of Russia had signed the

MOU with the government of India, in which the Gujarat Ayurvedic University is also

one of the implementing authorities.

The Ayurveda Faculty of the Institute of Medical Sciences, Banaras Hindu University,

Varanasi, Uttar Pradesh, which is under the Central Government administration, also has

similar programs. It has excellent facilities for imparting postgraduate training in different

disciplines of Ayurveda. It is collaborating in international research programs and attracting

graduates for training and research in Ayurveda, conducting basic research and publishing

in international journals. It has an advantage of sharing the research facilities and

clinical research with the medical institute’s research program. National Institute of

Ayurveda, Jaipur, Rajasthan also has an excellent research facility and similar training

programs and collaborations. The other postgraduate research centers also have very good

facilities and are involved in various important research collaborations.

1.5.2 Para Ayurvedic Staff

At present there is only one institute attached to Gujarat Ayurved University that conducts

courses in Ayurvedic pharmacy. There is an urgent need to establish many such institutes

to generate requisite manpower for the Ayurvedic drug manufacturing and dispensing

sector. This can be facilitated by formulating a national policy making it compulsory after

an initial grace period to appoint only qualified persons in the Ayurvedic manufacturing,

dispensing, and drug regulatory sectors. There is also a dearth of institutions to impart

training in Ayurvedic nursing. There is a need to open many such institutes and the present

practice of recruiting nurses trained in modern medicine has to be phased out. If such

persons are recruited, they should be made to undergo orientation training in Ayurveda.

Many special therapeutic approaches like Panchakarma, Ksarasutra, and Marmavidhya

are of great importance in Ayurveda.

© 2004 by CRC Press LLC

Ayurveda — A Potential Global Medical System

1.6 Research and Development

There are research councils and institutes functioning throughout the country on different

aspects of Ayurveda. In 1971, the government of India established a research council, the

Central Council for Research in Indian Medicine, Homoeopathy & Yoga (CCRIMH), which

was subsequently developed into four independent councils in 1978. The Central Council

for Research in Ayurveda and Siddha (CCRAS) is an apex body for the formation, coordination,

development, and promotion of research on scientific lines in Ayurveda and the

Siddha System of Medicine. The council has 89 field units under it, and they have been

reorganized into 30 institutes and units including the Headquarters Office (List 2 in this

chapter). The research activities in various fields can be broadly categorized as follows:

•

Clinical research

, encompassing clinical studies and programs in survey and surveillance,

community health, and tribal health.

•

Drug research

, encompassing medico-botanical surveys, cultivation of medicinal

plants, pharmacognostical studies, and phytochemical profiling of plants used in

Ayurveda, plant tissue culture, pharmacological and toxicological studies, and

drug standardization. It also has a breeding program for musk deer, which is the

source of the well-known drug Kasturi

.

Literary research

, encompassing publication of rare and classical manuscripts of

Ayurveda and Siddha, monographs on the basis of the studies undertaken by the

council, scientific journals and bulletins, newsletters featuring activities of the

council, and pamphlets on research findings; and preparation of video films on

various research achievements.

•

Family welfare research

, including studies on family welfare such as antifertility.

Besides CCRAS, research activities are carried out in other postgraduate institutes as

part of an M.D. dissertation and Ph.D. thesis. Research studies on Ayurvedic drugs and

therapies are carried out throughout the country in many conventional medical colleges

and research institutes, giving MBBS degrees — though not from an Ayurvedic perspective

but as part of conventional drug research. However, some institutes have done important

research work on Ayurvedic herbs. The major institutes conducting research on medicinal

plants are Seth GS Medical College (Mumbai), Central Drug Research Institute (CDRI,

Lucknow), Regional Research Laboratory (Jammu), National Institute for Pharmaceutical

Education and Research (NIPER, Mohali), Tropical Botanical Garden and Research Institute

(TBGRI, Trivandrum), Central Institute of Medicinal and Aromatic Plants (CIMAP,

Lucknow), National Botanical Research Institute (NBRI, Lucknow), pharmacology departments

attached to the Institute of Medical Sciences, Banaras Hindu University (Varanasi),

KG Medical College (Lucknow), SPARC (Mumbai), University Department of Pharmaceutical

Sciences, Punjab University, etc. In-house research activity is undertaken by some

of the large Ayurvedic drug manufacturers like Himalaya Drug Company, Dabur Research

Center, Zandu Research Foundation, etc. (Lists 1 and 2 in this chapter).

The present research approach, especially in the area of drug development and therapeutics,

needs to consider single plant as well as Ayurvedic concepts and text formulas.

Research protocols are often prepared without giving due consideration to the Ayurvedic

conceptual base that underlies employing a drug in a particular disease or clinical condi-

Scientific Basis for Ayurvedic Therapies

tion. The tendency is to treat medicinal plants used in Ayurvedic therapeutics as a source

material for drug prospecting for a single herb or chemical constituent and not for a drug

formulation. Ayurveda has a very well-developed discipline of Ayurvedic pharmacy and

drug formulation called

Bhaisajya Kalpana

, which deals in great detail with different methods

of drug preparations, use of adjuvant, maintaining ideal conditions, collecting and

processing drugs in a particular season at a particular stage and site, and others. There is

urgent need to study the impact of changes made in drug formulation and manufacturing

processes on the expression of biological activity and therapeutic efficacy.

Existence of the “therapeutic gap” in modern medicine is well known.

Though tremendous

progress has been made in the treatment of many dreaded diseases, remedies are

yet to be found for treating diseases like tuberculosis, cancer, rheumatoid arthritis, AIDS,

etc

.

In these areas TSM drugs and procedures may have beneficial effects. Similarly, TSM

drugs could be beneficial in the treatment of iatrogenic disorders like parkinsonism and

to attenuate drug-induced toxicity when administered as adjuvant. Intensive research

efforts are required to explore these possibilities.

1.7 Medicinal Plant Resources

The drugs used in the ISM are mainly plant based, in addition to a few materials of mineral

and animal origin. Thus the therapeutic efficacy of the drugs used in these systems is

greatly dependent on the use of pure and genuine raw materials in their preparation.

According to the estimation of the Department of ISM,

about 1100 medicinal plants are

estimated to find use in ISM & H drug preparation, and 500 of these are more commonly

used.

There are many problems in ensuring a constant supply of drugs; avoiding overexploitation

of medicinal plant resources; and also ensuring the quality of raw drugs and the

conservation, cultivation, and preservation of medicinal plants. To look into these matters,

the government of India has set up a Medicinal Plant Board, which has been given the

responsibility of coordinating all matters related to medicinal plants. The Planning Commission

set up a task force under Dr. D.N. Tewari, to

inter alia

provide policy directives

on (1) conservation and sustainable use of medicinal plants, (2) growth of domestic and

foreign trade, (3) development of an equitable market system, (4) regulation of this sector

to maintain quality control, and (5) protection of IPR of medicinal plants.

1.8 Ayurvedic Herbs and Herbal Formula Manufacturing

Ayurvedic medicines are marketed in various forms. They are available in the classical

forms like

gutikas

(tablets),

churnas

(powder),

asavas

and

aristas

(fermented products),

ghritas

(medicated ghee), and

kashayams

(decoctions). For topical use, drops, creams,

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

also in use. In addition, many patent drugs are sold in other modern drug presentation

forms like syrups, granules, creams, lotions, etc., which constitute around 65% of the

market share. There are more than 8500 manufacturers of Ayurvedic drugs in the country,

of which the annual return of 10 firms is more than Rs. 50 crores (approximately US $5

million — $1.00 is roughly equal to Rs. 48 crores), of 25 firms is between Rs. 5 and 50

crores, of 965 firms is between Rs. 1 and 5 crores, and the remaining is very small with

an annual turnover of less than Rs. 1 crore. The market share of Ayurvedic drugs is around

Rs. 3500 crores and that of Siddha drugs is around Rs. 5 crores.

3

Ayurveda is covered by the Drugs and Cosmetic Act (1940) and Rules (1945) of the

country, and the manufacturer is expected to comply with the rules delineated under

this act. In 1960, Chapter IV and other related chapters were added. Chapter IV deals

with the manufacture, sale, and distribution of drugs and cosmetics; Chapter IV-A,

which was subsequently added, deals with provisions related to Ayurvedic, Siddha, and

Unani drugs. In this chapter, 19 sections dealing with different aspects have been

described. All the drug manufacturing and dispensing activity in the country is covered

under this act. According to Clause 3(a) of this act, the definition of Ayurvedic drugs

includes all medicines intended for internal and external use for or in the diagnosis,

treatment, mitigation, or prevention of disease or disorder in human beings or animals

and manufactured exclusively in accordance with the formulae prescribed in the authoritative

texts of Ayurveda (which have been specified in the First Schedule of the act).

Clause 3(h) describes patent and proprietary medicines. This refers to formulations

prepared utilizing the drugs listed in the formulae mentioned in the authoritative texts

and mentioned under Schedule I but excludes drugs administered by parenteral route

and formulations mentioned in the books in the First Schedule.

 

Om Tat Sat

                                                        

(Continued...) 

(My humble salutations to H H Maharshi ji,  Brahmasri Sreeman Lakshmi Chandra Mishra ji and other eminent medical scholars and doctors   for the collection)