Journal of Ethnopharmacology 103 (2006) 2535

Perspective paper

Integrated approaches towards drug development from Ayurveda

and other Indian system of medicines
Pulok K. Mukherjee , Atul Wahile
School of Natural Product Studies, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India
Accepted 19 September 2005
Available online 2 November 2005

Abstract
Biodiversity of natural resources has served not only for the primary human needs but also for health care, since time immemorial. The Indian
subcontinent, with the history of one of the oldest civilization, harbors many traditional health care systems. Their development was supported
by the diverse biodiversity in flora and fauna due to variations in geographical landscaping. Ayurveda, whose history goes back to 5000 b.c., is
one of the ancient health care systems. The Ayurveda was developed through daily life experiences with the mutual relationship between mankind
and nature. The ancient text of Ayurveda reports more than 2000 plant species for their therapeutic potentials. Besides Ayurveda, other traditional
and folklore systems of health care were developed in the different time periods in Indian subcontinent, where more than 7500 plant species were
used. According to a WHO estimate, about 80% of the world population relies on traditional systems of medicines for primary health care, where
plants form the dominant component over other natural resources. Renewed interest of developing as well as developed countries in the natural
resources has opened new horizons for the exploration of natural sources with the perspectives of safety and efficacy. The development of these
traditional systems of medicines with the perspectives of safety, efficacy and quality will help not only to preserve this traditional heritage but
also to rationalize the use of natural products in the health care. Until recent past, the nature was considered as a compendium for templates of
new chemical entities (NCEs). The plant species mentioned in the ancient texts of these Ayurveda and other Indian systems of medicines may be
explored with the modern scientific approaches for better leads in the health care.
2005 Elsevier Ireland Ltd. All rights reserved.

Keywords: Indian system of medicines; Ayurveda; Siddha; Unani; Homeopathy

1. Introduction
Plants and plant-derived products are part of health care sys-
tem since ancient human civilizations. The need of new chemical
entities (NCEs) for health care is explored and served through
Abbreviations: WHO, World Health Organization; ISM, Indian system
of medicines; GMP, good manufacturing practices; ASU, Ayurveda; Siddha
and Unani; CCRIMH, Central Council for Research on Indian Medicine and
Homoeopathy; CCRAS, Central Council for Research in Ayurveda and Siddha
Medicines; CCRUM, Central Council for Research in Unani Medicines; CCRH,
Central Council for Research in Homeopathy; CCRYN, Central Council for
Research in Yoga and Naturopathy; ISM & H, Indian system of medicine and
homeopathy; NCEs, new chemical entities; NMPB, National Medicinal Plant
Board
This Perspective was written to be included in the 100th volume which was
published as 100/12, 22 August 2005.
Corresponding author. Tel.: +91 33 2414 6046; fax: +91 33 2414 6046.
E-mail address: pulokm@vsnl.net (P.K. Mukherjee).
the plant sources. In India, the history of health care goes back
to 5000 years b.c., when health care needs and diseases were
noted in ancient literatures like Rig-Veda and Atharva-Veda.
Later, the texts like Charak Samhita and Sushruta Samhita
were documented in about 1000 years b.c., where use of plants
and polyherbal formulations was highlighted for health care.
Evolution of Ayurveda and plant-based remedies for health care
through day-to-day life experiences is a part of cultural heritage
of India. The World Health Organization (WHO) estimates that
about 80% of the population living in the developing countries
relies on traditional medicine for their primary health care needs.
In almost all the traditional systems of medicine, the medicinal
plants play a major role and constitute their backbone. Indian
Materia Medica includes about 2000 drugs of natural origin
almost all of which are derived from different traditional sys-
tems and folklore practices (Narayana et al., 1998).
It is difficult to get reliable figures for the total number of
medicinal plants on earth; according to some estimation, around

0378-8741/$ see front matter 2005 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.jep.2005.09.024
26 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535
Fig. 1. World market of herbal remedies.
35,00070,000 plant species are being used worldwide in health
care systems (Farnsworth and Soejarto, 1991). According to
WHO estimations the populations in developing countries like
India (70%), Ruwanda (70%), Uganda (60%), Tanzania (60%),
Benin (80%) and Ethiopia (90%) extensively use traditional and
alternative medicines for health care. Plants and plant-based
products are an integrated part of most of the traditional and
alternative systems of medicines world wide. In developed coun-
tries like Belgium (31%), USA (42%), Australia (48%), France
(49%), Canada (70%), a significant percentage of the popula-
tion has used traditional and alternative remedies at least once
for health care (WHO, 2002). The global market of trade related
to medicinal plants is estimated around US $60 billions per year
and is growing at the rate of 7% annually with varying shares
(Fig. 1) of developed and developing countries (Dev, 1999; Laird
and Pierce, 2002; Raskin et al., 2002). A study reveals that about
42% of the best selling pharmaceutical products in 1997 were
biologicals or natural products or chemical entities derived from
natural resources, worth of US $17.5 billion (Laird and Kate,
2002).
1.1. Historical perspectives of Ayurveda
Ayurveda, which literally means the science of life, is one
of the oldest systems of medicines in India. The origin of
Ayurveda has been lost in prehistoric antiquity, but its concepts
and approaches have been perfected between 2500 and 500 b.c.
in India. This system of using natural resources for betterment
of health was developed through the experimentation and expe-
riences of day-to-day life style of Indian people. It is a holistic
system of health care with the concept, that the human body
is a matrix of seven basic tissues (Rasa, Rakta, Mansa,
Meda, Asthi, Majja, Shukra) and the waste products of
the body, such as feces, urine and sweat which are derived by
the five basic elements ether, air, fire, water and earth and three
basic types of energies or functional principles vata, pitta and
kapha (Tridosha). Any imbalance or disturbance in these basic
principles of body causes disease. In Ayurveda, the disease treat-
ment is employed to regain the balance of basic elements and
functional principles of the body. The growth and decay of this
body matrix and its constituents revolve around food which gets
processed into humors, tissues and wastes. Ingestion, digestion,
absorption, assimilation and metabolism of food have interplay
in health and disease, which are significantly affected by psy-
chological mechanisms as well as by bio- fire agni. Natural
resources which are also believed to be composed of these five
elements and three functional principles (Lad, 2002) are used
for treating the diseases in Ayurveda.
The experiences in the experimentations in day-to-day life
are documented in several classical treatises like Charak Sami-
hta, Sushruta Samhita, etc. Ayurveda is divided into eight
major disciplines known as Ashtanga Ayurveda, which con-
stitutes eight different disciplines as shown in Table 1. In
the last 50 years the teaching and training specialties of
Ayurveda are more focused towards diagnosis, treatment and
drug development as shown in Table 1, and have developed
into sixteen specialties. The treatments are enriched by accept-
ing THE and adopting outcomes of experience. Some mile-
stones in the development of Ayurveda are summarized in
Fig. 2.
1.2. Ayurvedic therapeutics
Ayurveda is based on experience from the time immemorial,
some of which has been proven experimentally. Formulations
and dosage forms have great importance in Ayurveda. Gen-
erally Ayurvedic formulations are multi-component mixtures,
containing plant and animal-derived products, minerals and
metals. Ancient texts like Rig Veda, Atharva Veda and offi-
cial compendia like Ayurvedic Pharmacopoeia, Ayurvedic For-
mulary show dominance of plant-derived products (Ayurvedic
Pharmacopeia of India, 2001, 2001a,b; Ayurvedic Formulary
of India, 2000). The Charak Samhita (900 b.c.) is considered
as THE first recorded treatise, devoted to the concepts and
practice of Ayurveda; its primary focus was therapeutics. This
work listed 341 plants and plant products for use in medicine.
The next landmark in Ayurvedic literature was the Sushruta
Samhita (600 b.c.), which has special emphasis on surgery.
It described 395 medicinal plants, 57 drugs of animal origin
and 64 minerals and metals as therapeutic agents. Sushruta, the
father of surgery, lived and practiced surgery in Varanasi, India,
approximately 2,500 years ago. Another important authority in
Ayurveda was Vagbhatta, who practiced around the 700 a.d. His
work Ashtanga Hridaya is considered unrivaled for the princi-
ples and practice of medicine. The Madhava Nidana (800900
a.d.) was the next important milestone; it is the most famous
Ayurvedic work on the diagnosis of diseases. The last cele-
brated writer on traditional Indian medicine was Bhava Mishra
of Magadha, whose treatise Bhava Prakasha, written around
1550, is held in high esteem by modern Ayurvedic practition-
ers for its descriptions of approximately 470 medicinal plants.
Other than these monumental treatises, more than 70 Nighantu
Granthas (pharmacy lexicons) were written, mostly between
the seventh and sixteenth century. Raj Nighantu by Narhari
Pandit and Madanpala Nighantu by Madanpala are consid-
ered masterpieces on medicinal plants. (Dev, 1999). Charak
Sanghita, an ancient text in Ayurveda classified the plant drugs
into 50 groups based on their Sanskrit name (see Table 2). Thus,
Ayurveda from its origin is a scientifically organized discipline.
Ayurvedic texts are much respected in neighboring countries
and were translated into Greek (300 b.c.), Tibetan and Chi-
nese (300 a.d.) and several other Asian languages (Mukherjee,
2001).
 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535 27

Table 1
Different streams and specialties in Ayurveda
Branches in Ayurveda Specialties for teaching and training of Ayurveda

Sanskrit English Sanskrit English Sanskrit English

Kaya-chikitsa Internal medicine Ayurveda-Siddhanta Fundamental Principals of Ayurveda Prasuti tantra Obstetrics and gynecology
Kaumar-bhritya Pediatrics Ayurveda-Samhita Ayurvedic text Swasth-vritla Social and preventive medicine
Bhoot-vidya Psychiatry Sharira-Rachna Anatomy Kayachikitsa Internal Medicine
Shalakya Ophthalmology Sharira-kriya Physiology Rog nidan Pathology
Shalya Surgery Dravya guna-vigyan Materia Medica and Pharmacology Shalya tantra Surgery
Agad-tantra Toxicology Ras-shastra Physiochemistry Shalkya Tantra Eye & ENT
Rasayana Geriatrics Bhaishajya-kalpana Pharmaceuticals Mano-roga Psychiatry
Vajikarana Eugenics and aphrodisiacs Kaumar-bharitya Pediatrics Panchkarma Detoxification of body

Fig. 2. Few milestones in the development of Ayurveda.

28 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535

Fig. 2. (Continued ).

1.3. Indian Systems of medicine 1.3.1. Homeopathy

The principle of Homoeopathy has been known since the time
Besides Ayurveda there are several other complementary of Hippocrates from Greece, the founder of medicine, around
and alternative systems of medicine like Homeopathy, Siddha 450 b.c. Homoeopathy as it is practiced today was evolved by
and Unani systems of medicine, which are also practiced and the German physician, Dr. Samuel Hahnemann (17551843).
developed with the course of time in India, where plants and The word Homoeopathy is derived from two Greek words,
plant-based formulations are employed for health care and dis- Homois meaning similar and pathos meaning suffering.
ease treatments. Homoeopathy simply means treating diseases with remedies,
which are capable of producing symptoms similar to the disease
Table 2
when taken by healthy people. For instance, Cinchona Bark,
Therapeutic classification of plant drugs as per Charak Sanghita
which contains quinine, is taken by a healthy person; it pro-
Sanskrit name Use duces symptoms that exactly mimicked intermittent fever (now
Balya Promoting strength called malaria). Homeopathy is being practiced since more than
Jivaniya Promoting longevity 150 years in India. It has blended so well into the roots and tra-
Dipaniya Promoting digestion ditions of the country that it has been recognized as one of the
Lekhaniya Promoting anti-obesity
National Systems of Medicine and plays an important role in
Verne Promoting complexion
Krmighna Promoting anthelminsis providing health care to a large number of people.
Stanyajanana Galactogogue
Vamanopaga Emetic 1.3.2. Siddha
Kasahara Antitussive Siddha system of medicine is developed since the ancient
Svayathyhara Anti-inflammatory human civilization in India. Like Ayurveda, it is developed
Javarahara Febrifuge through day-to-day experiences of using natural resources for
Vedanasthapana Analgesic
Vayahsthapana Antiaging
health care. The Siddha system is one of the oldest systems of
medicine in India. The term Siddha means achievement and the
 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535
Siddhars were saintly figures who achieved results in medicine
through the practices. The system is believed to be developed by
18 Siddhars, who glorified human being as the highest form
of birth and believed that preserving the human body is essen-
tial to achieve the eternal bliss. The principles and concepts of
this system are closely similar to those of Ayurveda, with spe-
cialization in iatro-chemistry. As in Ayurveda, This system also
considers the human body as a conglomeration of three humors,
seven basic tissues and the waste products. The equilibrium of
humors is considered as health and its disturbance or imbalance
leads to disease or sickness. The system describes 96 principal
constituents of a human being which include physical, physio-
logical, moral and intellectual components. When there is any
change or disturbance in functioning of these principals, body
as a system deviates towards the cause of disease (Pillai, 1998).
The diagnostic methodology in the Siddha system is eight-fold,
including examination of pulse, tongue, complexion, speech,
palpatory findings, and so forth. Perception has a great role in
this venture; this can be achieved by sensory organs, by mind,
by yoga, by pain and pleasure. The Siddha system is a psycho-
somatic system, where attention is given to minerals and metals
along with plant constituents (Mukherjee, 2001).
1.3.3. Unani
The Unani system of medicine owes its origin in Greece.
It was the Greek philosopherphysician Hippocrates (460377
b.c.). Greek and Arab scholars like Galen (131212 a.d.),
Raazes (850925 a.d.) and Avicenna (9801037 a.d.) enriched
the system considerably. In India, Arabs introduced the Unani
system of medicine, which was developed and blended with the
Indian culture under the Mughal Emperors. The Unani system
of medicine is used by a large portion of the population in India.
Unani considers the human body to be made up of seven compo-
nents. Arkan-elements, Mizaj-temperaments, Aklath-humors,
Anza-organs, Arawh-spirits, Quo-faculties and Afal-functions,
each of which has a close relationship with the state of health
of an individual. A physician takes into account all these factors
before diagnosing and prescribing treatment. In Unani medicine,
single drugs or their combinations in raw form are preferred over
compound formulations. The naturally occurring drugs used in
this system are symbolic of life and generally free from side
effects. Such drugs, which are toxic in crude form, are processed
and purified in many ways before use.
In Unani system of medicines, the diseases are considered as a
natural process, and their symptoms are the reaction of the body.
So the chief function of the physician is to aid the natural forces
of the body. The basic principle of the Unani system of medicine
is parallel to Ayurveda. This system believes that every person
has a unique humor constitution, which represents his healthy
state (Siddiqui, 1996). Hippocrates was the first physician to
introduce the method of taking medial histories, which gave rise
to the development of humoral theory. The humoral theory
presupposed the presence of several humors- Dam (blood) Bal-
gham (phlegm), Safra (yellow bile) and Sauda (black bile) in
the body. The temperament of people is expressed by the words
sanguine, phlegmatic, choleric and melancholic according to the
preponderance in them of the respective humors blood, phlegm,
29
Fig. 3. Number of plants used in different systems of medicines in India.
yellow bile and black bile. The humors themselves are assigned
temperaments. Blood is hot and moist, phlegm is cold and moist,
yellow bile is hot and dry and black bile is cold and dry. The
Unani system believes that every person has a unique humoral
constitution that represents its healthy state. There is power of
self preservation or adjustment called the medicatrix nature
or the defense mechanism, which strives to restore disturbances
with in the limit prescribed by the constitution of an individ-
ual. If this power regains, imbalance in humor compositions is
bound to occur and this causes diseases. Types of treatments pre-
scribed in the Unani System of medicine are regimental therapy,
diet therapy and pharmaco-therapy:
Regimental therapy includes diaphoresis, diuresis, Turkish
bath, massage purging, emesis and so forth.
Diet therapy aims at treating certain ailments, by administra-
tion of specific diets or by regulating the quantity and quality
of food.
Pharmaco-therapy deals with the use of herbal medicines.
In this traditional system of medicines a single drug or combi-
nations in raw form are preferred over compound formulations.
The system offers excellent remedies for gastrointestinal, car-
diovascular and nervous disorders tested through many centuries
(Mukherjee, 2002a).
Though the origins and development periods of these sys-
tems of medicine are different, but there is a common thread
running through these systems in their fundamental principles
and practices by using the plants and plant-based formulations
in the health care. The proportion of use of plants in various sys-
tems of medicines is shown in Fig. 3 (Ramakrishnappa, 2002).
Around 70% of population in India relies on these systems for
primary health care.
2. Current situation in Indian system of medicines
Ayurveda and other Indian systems of medicine have been
developing since the first human civilizations in the Indian sub-
continent. These systems are based on experience and interaction
with nature and natural resources. Scientific evidence to prove
the rationale of using these formulations in health care is essen-
tial to develop and to preserve the cultural heritage.
Variations in geographical landscaping and biodiversities in
the Indian subcontinent have helped to develop the use of a vari-
ety of plant species and other natural resources for health care
and contributed to the Materia Medica of traditional systems of
30 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535
Fig. 4. Distribution of medicinal plant used in Indian system of medicines.
medicine. More than 25000 single or polyherbal formulations
are used by the tribal and rural population in India. A morpho-
logical differentiation in plants used in different Indian system
of medicines (ISM) is summarized in Fig. 4. Ayurveda and ISM
utilize a vast number of plant and their different parts (Fig. 5) in
health care. Using the different parts of plants is mainly based
on the experience since the ancient times. ExportImport Bank
reports reveal that the global trade of plant-derived and plant-
originated products is around US $60 billion (with growth of 7%
per annum) where India holds stake of US $1 billion (Raskin et
al., 2002). Many important modern drugs are plant-based or
derived directly or indirectly from the plants. But only 6% of
all therapeutically important species, which are noted in ancient
literature, have been analyzed phytochemically for their thera-
peutic potential (Choudhary, 2002).
The plants used in Ayurveda and other ISM may be of inter-
est to find new leads for treating different diseases. Approaches
like high-throughput screening, phytochemical profiling, qual-
ity controls and standardization of raw materials and finished
products, clinical trials, herbal therapeutics, pharmacokinetics
and herbal pharmacovigilance will not only help to prove the
rationale of using these systems but also to get maximum ben-
efits of the natural resources (Mukherjee, 2003, 2005). The
Ministry of Health and Family Welfare, Government of India,
has taken different initiatives for the development and preser-
Fig. 5. Break up of medicinal plant used in the Indian system of medicines by
their parts utilized.
vation of these cultural heritages. The Department of AYUSH
(Ayurveda, Siddha, Unani and Homeopathy) is regulating edu-
cation and research in these systems. The National Medicinal
Plant Board [NMPB], which is constituted to deal with the con-
servation and research issues in botanicals, is working to address
the different issues in these aspects. Various stages of develop-
ment of Ayurveda are summarized in Fig. 2.
2.1. Government initiatives in the development of
traditional systems of medicine in India
The development of Indian systems of medicine gained con-
siderable momentum after independence. Even prior to inde-
pendence several committees were appointed that underscored
the future role to be played by the indigenous systems of
medicine. In 1969 the government established a Central Council
for Research on Indian Medicine and Homoeopathy [CCRIMH]
to develop scientific research on different systems of medicine:
Unani, Ayurveda, Siddha, Yoga, Naturopathy and Homoeopa-
thy. Research activities on these systems continued under the
CCRIMH until 1978 when it was split up into four separate
research councils. Central Council for Research in Ayurveda
and Siddha Medicines [CCRAS], Central Council for Research
in Unani Medicines [CCRUM], Central Council for Research
in Homeopathy [CCRH], Central Council for Research in Yoga
and Naturopathy [CCRYN]. These central councils have their
own research institutes, laboratories and dispensaries through-
out India, which work on the development and propagation of
the respective system and the development of lead compounds
from the traditional systems for major ailments. The individual
laboratories and institutes under the control of the individual
councils and their research activities are listed in Table 3. In
1995, the Department of Indian System of Medicine and Home-
opathy (ISM & H) was established by the Government of India
under the Ministry of Health and Family Welfare to control all
regulations related to traditional systems of medicine. The man-
ufacture, quality control and sale of all Ayurvedic and other
ISM medicines are regulated through the Drug and Cosmetic
Act 1940 where various acts and regulations have been made
by Government of India for the development of herbal medicine
as shown in Table 4. Chapter IVA of the Drugs Act (DA) as
amended in 1964 deals with several sections depicting the var-
ious regulatory controls on ISM. Different section deals with
drug regulation as follows:
Section 3-a of this act deals with classical preparations which
constitute 35% of ISM products. They are manufactured
exclusively according to the formulae described in authorita-
tive books of Ayurveda, Siddha and Unani (ASU) as specified
in the first schedule of the Act.
Section 3-h deals with patent and proprietary medicine which
constitute 65% of ISM products.
For the proper development of Ayurveda, so much so the
ISM implementation of good manufacturing practices (GMP) is
a must. Government of India Gazette notification in June 2000
has stressed the need for GMP in ASU drugs. Several specifi-
 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535 31

Table 3
Government institutes dealing with the research and development of the traditional systems of medicines in India
Name of the council Different centers of the council Research activities

Central Council for Research
in Ayurveda and Siddha
Central Council for Research
in Unani Medicines
Central Council for Research
in Homeopathy
Central Council for Research
in Yoga and Naturopathy
Council for Scientific and
Industrial Research and
regional laboratories
8 regional research institutes Medico-botanical survey and development of Ayurvedic
and Siddha medicine based on folklore uses and their
scientific validation and implication
12 research centers
60 units and dispensaries
1 central research institute Developing independent and multidimensional research
into various fundamental and applied aspects of Unani
system of medicine
8 regional research institutes
11 clinical research units
5 drug standardization units
51 research centers around the country Screening of homeopathic medicines for treating dif-
ferent ailments and development of standardization
parameters
Headquarter and central unit at New Delhi, India Development and propagation of natural cure, yoga and
related aspects of yoga and naturopathy
Regional research laboratory, Jammu Cultivation of medicinal plants, quality control and inves-
tigation of medicinal plants and pharmacology including
development of agro-biotechnological aspects
Central drug research institute, Lucknow
Central institute of medicinal and aromatic plants Lucknow

cations have come out on this aspect for improving the quality
and standard of ASU drugs manufactured in about 9000 licensed
ASU pharmacies in the country. Assessment of finished products
should embrace all relevant factors, including the production
conditions, the results of in-process testing, the manufactur-
ing (including packaging) documentation, compliance with the
specification for the finished product, and an examination of the
finished pack (Mukherjee, 2003b).
Quality control and research on traditional systems are fur-
ther regulated by the Department of Indian System of Medicine
and Homeopathy (ISM & H). Pharmacopoeial committees have
been established and the ISM & H council has established a
separate pharmacopoeial laboratory. A separate drug control for
traditional systems of medicines have been created by the depart-
ment of ISM & H. Government initiatives have come up with
separate pharmacopoeias and formularies with the monographs
on plants and formulations used in these systems of medicines;
official compendia on Indian system of medicines are shown
in Table 5. These official compendia contain monographs on
single plants as well as formulations used in Indian systems of
medicine.
Table 4
Several acts administered in development of Indian system of medicine
Name of the act Year of establishment
Central Council of Indian Medicine Act 1973
Central Council of Homeopathy Act 1973
Drugs and Cosmetics Act-1940 and Rules 1940
thereunder
Drugs and magic remedies [objectionable 1954, 1955
advertisement] Act and Rules thereunder
Medicinal and toiletries preparation Acts and 19951996
Rules
3. Prospects of plant-based health products from
Ayurveda
Around 60% medicinally useful formulations and other
health products, which are either derived or developed from
plant origin dominate the global market of health care prod-
ucts. In India, around 25,000 effective plant-based formulations
are used in traditional and folk medicine. More than 1.5 million
practitioners are using the traditional medicinal system for health
care in India. It is estimated that more than 7800 manufacturing
units are involved in the production of natural health products
and traditional plant-based formulations in India, which requires
more than 2000 tones of medicinal plant raw material annually
(Ramakrishnappa, 2002).
Use of herbal medicines is wide spread in developing as well
as developed countries. Sale of plant-based products showed
an increase of around 40% during 19921996 in USA, which
was of US $14 billion in 1996. Increased use of plant-based
health products was observed in other European countries
(Schilter et al., 2003). In India the use of plant-derived prod-
ucts in health care is very common; around 70% of modern
medicines originate from natural resources and plants. India
is also considered as one of the potential exporting coun-
tries of medicinal plants. Pharmaceutical companies engaged
in the production of plant-based products showed around 15%
of average growth (Kumar, 2003). Japan and European coun-
tries recorded an increase in the import of medicinal plants
and plant-based products. Germany, as largest importer of the
medicinal plant is spending around US $2.2 billion annually
(Wakdikar, 2004). Proper methodologies for the research and
development, manufacturing and quality control for the formu-
lations in Ayurveda and investigations of therapeutic potentials
of plants used in Ayurveda, with the support of scientific methods
32 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535

Table 5
Official compendia on Indian system of medicines published by Department of
Indian Systems of Medicine and Homoeopathy, Ministry of Health and Family
Welfare, Government of India, New Delhi, India (www.indianmedicine.nic.in)
Publication Year Number of
monographs

Ayurvedic Pharmacopoeia of India-I 1990 80

Ayurvedic Pharmacopoeia of India-II 1999 70
Ayurvedic Pharmacopoeia of India-III 2001 100
Ayurvedic Pharmacopoeia of India-IV Under 150
preparation
Ayurvedic Formulary of India -I 1976 444
Ayurvedic Formulary of India -II 2000 191
Indian herbal pharmacopoeia Vol. I 1998 20 Fig. 6. Plants distribution in Ayurveda according to their therapeutic potentials.
Indian herbal pharmacopoeia Vol. II 1999 20
Indian Herbal Pharmacopoeia (revised 2002 52
new edition)
Homoeopathic Pharmacopoeia of India 1971 180
sides, tannins, lipids, alkaloids, etc. These active principles or
Vol. I compounds with similar structure and activity may be manufac-
Homoeopathic Pharmacopoeia of India 1974 100 tured to produce the synthetic drugs used in the modern system of
Vol. II medicine.
Homoeopathic Pharmacopoeia of India 1978 105 The plants used in Indian Systems of Medicine showed the
Vol. III
Homoeopathic Pharmacopoeia of India 1984 107
presence of a variety of chemical entities, belonging to differ-
Vol. IV ent classes as shown in Fig. 7. This chemical and therapeutic
Homoeopathic Pharmacopoeia of India 1987 1l4 diversity in natural products is widely viewed as a source of
Vol. V templates for structure optimization programs designed to make
Homoeopathic Pharmacopoeia of India 1990 104 perfect new drugs, referred as new chemical entities. Despite
Vol. VI
Homoeopathic Pharmacopoeia of India Under print 105
the current preoccupation with synthetic chemistry as a vehicle
Vol. VII to discover and manufacture drugs, the contribution of plants to
Homoeopathic Pharmacopoeia of India Ready for 101 disease treatment and prevention is still enormous. In the 1970s,
Vol. VIII press 25% of all drugs dispensed in the USA contained compounds
National Formulary of Unani Medicine Under print 202 derived from flowering plants (Farnsworth and Morris, 1976).
Part II
National Formulary of Unani Medicine Under print 103
Through the development of new technologies rapid isolation
Part III and characterization of the molecules can be made from the plant
Unani Pharmacopoeia of India Part I Under print 45 species mentioned in the ancient texts of traditional medicine. In
Unani Pharmacopoeia of India Part II Under print 98 Ayurveda and other Indian systems of medicines, use of different
Unani Pharmacopoeia of India Part III Under print 103 plants for treating ailments was based on the fact that the addi-
tive or synergistic effects of the secondary metabolites present
may help to use these health products with maximum possible in those plants enhance therapeutic viability of the phytocon-
efficacy. stituents. Unlike modern medicines, Ayurvedic concepts believe
in treating complex diseases with a complex combination of nat-
3.1. Ayurvedic natural productstemplates for new ural health products, including plants and minerals, with doses
chemical entities based on the stage of the disease and individual patient. So,
for developing NCEs from Ayurvedic products several factors
Throughout the history of drug development plants are an should be considered, such as:
important source for the discovery of novel therapeutically
active compounds. Many compounds have been derived from identification and authentification of the species based on
the plant species mentioned in the ancient texts of Indian sys- exploitable resources;
tem of medicine for the treatment of a number of ailments. Many sustaining favorable regulatory environments;
plant-based formulations are being used in traditional systems sharing knowledge of adverse reactions, interactions to assure
of medicine for varied ailments; the plants used in these for- safety of the product;
mulations showed wide diversity in their therapeutic potentials development of technologies for rapid and efficient discover-
(Mukherjee, 2003a). Plants distribution in Ayurveda is accord- ies and manufacturing processes for natural health products.
ing to their therapeutic potentials is summarized in Fig. 6 (Khan
and Balick, 2001). Plant-based drugs may be used directly, i.e. 4. Quality control in traditional Indian systems of
they may be collected, dried and used as therapeutic agents medicine
(crude drugs) or their chief constituents/active principles might
be isolated by various chemical processes and employed as Quality control of traditional medicines is a critical and essen-
medicines. The active principles may be carbohydrates, glyco- tial issue to be considered in assuring the therapeutic efficacy,
 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535 33

safety and to rationalize their use in the health care. In almost all
the traditional systems of medicine, the quality control aspect has
been considered from its inception itself by the Rishis, expert
saints in medicines and later by the Vaidyas and Hakims, who
used these medications for treatment of the patients. However,
in modern times it requires changes in the approach. For the
quality control of traditional medicine, the traditional methods
are procured, studied, documented and then the traditional infor-
mation about identification and quality assessment is interpreted
properly in terms of modern assessment. Quality assurance is an
integral part of traditional medicine, which ensures that it deliv-
ers the required quantity of quality medicament. Today, quality
assurance is the thrust area for traditional formulations like chur-
nas, bhasmas, liquid orals, Lehas, etc. In former days these
traditional medicinal formulations were prepared by Vaidyas
and delivered to the patients in the fresh form where quality
assurance was not needed in the present way (Mukherjee, 2001,
2002). For the quality assurance of churnas and bhasmas, stom-
atal index, palisade ratio, fiber content, ash content including
acid soluble and water soluble ash, specific surface area, fre-
quency distribution, particle size and numbers are measured.
For liquid oral preparations, different analytical procedures like
titrimetry, gravimetry, etc. are followed. For lehas (paste prepa-
rations) extraction with solvents and their analysis by suitable
techniques like titrimetry, fluorimetry and nephelometry are
followed.
The finger printing and marker compound analyses are nowa-
days getting momentum for the standardization of traditional
medicinal formulations. Here, the concentration of the sec-
ondary metabolites, which are the major constituents of herbal
drugs, is studied, which provides valued scientific standardiza-
tion procedures. This technique helps not only in establishing the
correct botanical identity but also helps in regulating the chemi-
cal sanctity of the herbs. Out of these marker compounds, some
are therapeutically active and others may not be active but are
present in abundant quantity, which helps in their standardization
(Mukherjee, 2002b); for example, withanolides from Witha-
nia somnifera are therapeutically active marker compounds but
aegelin from Aegle marmelos is not therapeutically active but
its presence is already established, so it can be used as a marker
compound.

5. Conclusion

Due to certain inimical interferences with the Indian sys-

tem of medicine over the centuries, a need has arisen to unify
the entire system and codify it. In this context, laying down
the standards of Ayurvedic drugs is of paramount importance.
This is more so because these days the Ayurvedic drugs are
increasingly coming from the industry rather than the ayurvedic
physician compounding them impromptu. Moreover, commer-
cially ayurvedic drugs can make a dent in international markets,
which are looking towards alternative medicine for the cure
Fig. 7. Few phytoconstituents found in plants used in Indian system of
of ailments to which even the modern system has no answer
medicines.
(Mukherjee, 2003). More than 70% of threatened medicinal
plants of India are in active trade. There should be a focus
on collaborative efforts to protect and enhance the population
34 P.K. Mukherjee, A. Wahile / Journal of Ethnopharmacology 103 (2006) 2535
of these threatened, yet traded plant species. We know that
there exists an uncertainty of raw material supply and indis-
cernible levels of sustainability; still medicinal plants are col-
lected from the wild despite the demand for cultivation. If this
condition persists the excitement over the discovery of new
phytochemicals will be short lived, as the fear of extinction
of these valuable resources is looming large (Mukherjee et al.,
1998).
To establish the potentiality of Ayurvedic medicine, research
needs to be conducted on different disciplines of Ayurveda
(Table 1) to meet the requirement of the society based on the
following aspects:
To standardize materials, methods and measures for prepa-
ration, preservation, presentation and administration of
Ayurveda drugs.
To provide proper scientific validation and significance to the
fundamental principles of the system to the extent possible,
so that they can be accepted within a scientific framework.
To rationalize the utility of positive and judicious use of
modern scientific methods that pertain to the development
of Ayurveda.
Nevertheless, in doing so the major efforts in this direc-
tion may be augmented by introducing the element of research
in Ayurveda and similar Oriental disciplines, which generally
means the application of scientific tools and techniques for
new understanding about the terms of these practices. Medic-
inal herbs as potential source of therapeutic aids have attained
a significant position in health systems all over the world for
both humans and animals not only in the diseased condition but
also as potential material for prevention. Plants will continue
to serve for the exploration of new chemical entities and also
as raw material for semi-synthetic chemical compounds used
in health care systems (Hoareau, 1999). Thus, development of
the Ayurveda and other traditional Indian Systems of Medicine
may help to tap the traditional ethnopharmacological knowledge
through modern approaches.
Acknowledgements
The authors express their gratitude to Department of Biotech-
nology (DBT), University Grants Commission (UGC), Depart-
ment of Science and Technology (DST), New Delhi for
providing financial assistance through various research projects
to the School of Natural Product Studies, Jadavpur University
for development and evaluation of natural health products of
India.
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