Dr Danister L. Perera, Consultant (Ayurveda); danister@mobitelnet.

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Seminar on Indigenous Medicine: Role of Chemists and Recent Advances: 2014.05.21 Page 1
Present and Future of Ayurvedic Industry with Scientific Advancements
Sri Lankan Ayurveda or traditional medicine culturally renowned heritage of the country and it historically
played a key role in traditional healthcare from the past. According to WHO information 80% of world
rural population relies on traditional medicine for their day to day health problems while 35% of Sri
Lankan population is primarily depend on traditional medicine for healthcare needs. The traditional
medical service providers in both government and private sectors cover the all-island consumer needs at
national level while some products are exported to foreign market also. In Ayurvedic market
pharmaceuticals, nutraceuticals and cosmeceuticals based on traditional recipes are of great importance
as a reservoir of chemical diversity aimed at new drug discovery. Natural products still play a very
important role in the traditional medicine of developing countries rural population and become more
popular among developed countries also. Not only in traditional medicine but also in other systems
medicine like homeopathy and modern medicine use plants as their medicinal sources and can be
explored as potential antimicrobial, cardiovascular, immunosuppressive, and anticancer drugs.
Over the last decade, herbal medicines have enjoyed a revival in many developed countries, including the
United States (USA), Europe, Australia and Canada and the global market for herbal medicines is sparse
due to some legal restrictions. But the herbal medicine industry is one of the fastest growing industries in
the world where the Europe leads the world market with an impressive figure of US$ 7 billion, followed
by Asia, North America, and Japan. Demand for herbal medicines in Europe was almost static in the late
1990s, while in North America it had steadily increased during this period. In Asia, the demand had
almost doubled during the late 1990s, partly from the increasing population pressure. Latin America and
Eastern Europe have a retail sale of US$ 600 million and 400 million respectively while the share of Africa
and Middle East together, and rest of the world is about US$ 200 million each. The market for herbal
medicines in the USA was below one billion US dollars at the beginning of this millennium and in 1980
consumers in the USA paid more than $ 8,000 million for prescriptions containing active principles
obtained from plants. The sale of these plant-based drugs in the USA valued to nearly US$ 4.5 billion in
1980 and US$ 15.5 billion in 1990. In 1999, it had a retail sale of US$ 3.8 billion and an estimated sale of
US$ 4.5 billion in 2002. The consumer use of these products in the USA has increased by staggering 380
per cent in the past ten years. In 2005 more than US$ 14 billion was spent on such remedies in China
alone and In 2007 US citizens spent nearly $15 billion on over-the-counter natural products which is a
part of global market of more than US$ 60 billion.
In 1990 it is estimated that about 64% of the world's population or 3.2 billion people who largely unable
to afford modern medicine use plants as medicines which are economically worth trillions of dollars. Of
the 520 new drugs that came to the market in the USA between 1983 and 1994, 44% (231 of 520) of all
drugs and 65% (59 of 91) of anti-infective drugs were derived from natural sources. A study of the 25
best-selling pharmaceutical drugs in 1997 found that 11 of them (42%) were entities derived from natural
sources, with a total value of US$ 17.5 billion. Global market for herbal medicines was estimated at US$
12.4 billion in 1994, projected by increasing to US$ 19.6 billion in 1999. The total market for plant-derived
drugs was valued at US$ 22.6 billion in 1997 and was projected to reach US$ 30.6 billion in 2002,
representing an average annual growth rate (AAGR) of 6.3 per cent. The overall international trade in
medicinal plants and their products has been estimated at over US$ 60 billion in 2000 while the around
80% of all natural products are of plant origin of which the sales exceeded US$ 65 billion in 2003. Based
on WHOs 2001 estimate of US$ 45 billion with an annual growth rate of 515 percent, 2004 global
market for herbal medicines including herbal products and raw materials was estimated to be US$ 65
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Seminar on Indigenous Medicine: Role of Chemists and Recent Advances: 2014.05.21 Page 2
billion. The global market for herbal medicines stood in 2005 around US$ 60 billion and the same figure
accounted only for US market in next year. According to the Herbal Supplements and Remedies: A
Global Strategic Business Report by Global Industry Analysts the global herbal supplements and
remedies market is forecasted to reach US$ 93.15 billion by the year 2015 and of US$ 107 billion by the
year 2017 which is according other source with AAGR of 7 per cent expected to reach US$ 5 trillion by
2050.
The worldwide sale during last decade has increased with an AAGR between 5 to 15 per cent, depending
on the region. Europe leads the market, followed by Asia, North America and Japan. The industrial
demand for medicinal plants has increased exponentially in the world market since last few decades with
the emergence of newer product categories like health foods, natural cosmetics and personal hygiene
products. One of the largest and most important databases on natural ingredients used for products is
NAPRALERT, contains records from the world literature on the chemical constituents of plant, microbial
and animal (primarily marine) extracts, and on the chemistry and pharmacology of secondary metabolites
of known structure derived from natural sources. With the enhanced global attention on traditional
medicine the researching of medicinal properties of traditional recipes has become a profitable and well-
supported by financial funding in pharmaceutical sector. Hence the utility of the formulas derived from
various systems of traditional medicine (ethnomedicine) for drug discovery purposes is becoming a latest
trend of pharmaceutical industry. In international forums advantages and disadvantages of using plants
as starting points for drug development, specifically those used in traditional medicine are now being
discussed. Further it is noted that conventional pharmaceutical development process takes about ten
years from the discovery of a potentially valuable chemical until a new pharmaceutical product that is
ready for sale, and costs more than US$ 500 million. Ethnomedical knowledge-based hypothesis driven
drug discovery is economically sound pathway to avoid time consuming expensive chemical screening
and animal studies.
Plants synthesize a wide variety of chemical compounds or phytochemicals many of which have
beneficial effects on long-term health and can also be used as effective treatments for human diseases.
Estimated percentages of "green" products produced by some major pharmaceutical firms are high in
number and their drugs, as listed in PDR were evaluated to see what percentage still contained natural
products as one of the major ingredients. A generous scoring, allowing all vitamins and amino-acids,
acetic acid, lactose, as major or minor ingredients or excipients would give at least 50% "green" and in
addition to pharmaceuticals there are nutraceuticals, functional foods and cosmaseuticals based on
natural plant derivatives share the market widely. Thus, the final percentage of plants or plant-derived
extracts in modern pharmaceuticals will ultimately depend upon your definition of phytomedicinal
compounds. With increasing demand of natural product medicines and augmented on the other hand, as
a consequence of new drug developments from plants, phytopharmaceuticals are projected to increase
their market share. Modern drugs discovered from natural products.
A recent survey conducted by members of the Medicinal Plant Specialist Group of the IUCN Species
Survival Commission suggests that 72,000 species of higher plants are used medicinally worldwide,
approximately 17% of the worlds higher plant flora. Of these, only about 6% have been screened for
biologic activity, and a reported 15% have been evaluated phytochemically for bioactive compounds and
medical potential. There are more than 135,000 structurally characterized plant-derived natural products
of which a pharmaceutical company may have 1,000-2,000 of these in its library. Therefore the chemical
and biological diversity of plants represent a potentially limitless renewable source for the use in the
Dr Danister L. Perera, Consultant (Ayurveda); danister@mobitelnet.lk
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development of new pharmaceuticals. As reported during 1986 to 1995 the National Cancer Institute of
United States, using improved screening methods, had produced 40,000 plant extracts for screening and
of the 18,000 screened for anticancer activity about 0.01 had showed some positive activity. At least
12,000 such compounds have been isolated so far, a number estimated to be less than 10% of the total.
Global pharmaceutical companies in the discovery of novel molecules it is expected that the share of
plant-derived prescription drugs will increase to 30 per cent in the next few decades. Market value of
drugs of which the source material based on plants, statistical value of life of lives saved using plant
based drugs, have suggested the range US$ 0.39 to US$ 7.00 billion as the annual value of a plant based
drug. The plant derived active ingredients have been valued at US$ 7.6 billion in 1997 and were expected
to reach US$ 12.4 billion in 2002, at an AAGR of 10.1%. Glycosides sale was valued US$ 7.3 billion in 1997
which was projected to increase to US$ 9.2 billion in 2002 with an AAGR of 4.8%. Alkaloids turnover was
projected to reach US$ 4 billion in 2002 from US$ 3.6 billion in 1997 representing an AAGR of 2.4%.
Between 1983 and 1994 41% of new approved drugs had natural products as they are rich in structurally
diverse bioactive molecules that quite often become potential candidates for new drugs. 120 therapeutic
agents in the USA, 25% of all prescriptions dispensed from community pharmacies from 1959 to 1980
contained plant extracts or active principles prepared from 90 different higher plant species. About 121
(45 tropical and 76 subtropical) compounds of defined structure, obtained from only 94 species of plants
have been identified for which no synthetic one is currently available. As a more recent study revealed, of
the top 150 proprietary drugs used in the USA in 1993, that 57% of all prescriptions contained at least
one major active compound currently or once derived from (or patterned after) compounds derived from
biological sources. Additionally, the 20 best-selling drugs worth about six billion a year currently come
from natural sources. In fact, in 1996, six out of the top 20 pharmaceutical prescription drugs dispensed
were based on derivatives of natural products. The bioactive ingredients or phytochemical compounds
which are used as drugs and demonstrate that 80% of these have had an ethnomedical origin identical or
related to the current use of the active elements of the plant.
WHO has published many technical reports related to consumer information, worldwide regulations,
quality standards, research methodologies and four volumes of selected medicinal plants totaling 116
monographs. Most of the technical expertise have identified significant thrust areas to be researched and
prioritized in a timely manner which are also related to medicinal plant resources like economic mapping
of autogenic flora, selection of plant species and verification, incorporation of Ethnomedical and
Ethnobotanical data, trial propagation for developing high yield varieties, medium scale plant
propagation, phytochemical studies on herbal ingredients, quantitative and analytical studies on main
ingredients etc. One of the most significant recommendations is to establish a Knowledge Based on
herbal medicines and their uses. This is a very important step to be taken in order to drive the industry
towards a productive goal, and to coalesce with mainstream industrial interventions. This will support an
information network and data system programmed to be accessible to relevant stakeholders involved in
the herbal healthcare product sector. Especially the Ayurveda sector will be benefitted through such a
knowledge base by crossing over international market constraints and improvement of the quality of
products.
Ayurvedic pharmaceutical industry is very much fast growing sector in line with domestic requirement
and global demands which has been increased in significant rate during the last decade of second
millennium. Regulatory measures and quality standards pertaining to traditional medicinal products were
major issues taken up in national and international forums during past few decades. Specially in
Dr Danister L. Perera, Consultant (Ayurveda); danister@mobitelnet.lk
Seminar on Indigenous Medicine: Role of Chemists and Recent Advances: 2014.05.21 Page 4
European community has changed positively and flexibly to review scientific background of natural
medicine and looked consciously at the core of alternative systems of medicine including Ayurveda.
Regulatory procedures directly have an impact on rational use, consumer protection and minimal risk
involvement. WHO has reported legal status of regulatory frameworks existed worldwide. Quality, safety
and efficacy were major concerns expressed by WHO in its conclusive reviews. Regulatory data and
information on Ayurvedic products shared with national authorities are inadequate and not reflected in
national policies. As stated by WHO Evaluation of TM/CAM products is also problematic. This is
especially true of herbal medicines, the effectiveness and quality of which can be influenced by
numerous factors. Unsurprisingly, research into TM/CAM has been inadequate, resulting in paucity of
data and inadequate development of methodology. This in turn has slowed development of regulation
and legislation for TM/CAM. It is emphasized by WHO as Herbal medicines are the most popularly used
form of TM/CAM medication therapy. However, in some countries animal, mineral, or other materials
may also be used. Therefore, in these cases, regulations should be specifically tailored to address each
countrys unique situation. Regulatory systems for the quality assurance and registration of herbal
medicines will improve the quality of products and enable consumers to use high quality product. There
is an urgent need for redrafting national legislations for accommodating good review practices in terms
of pharmaceuticals in any system.
In 2004 JAMA Recently, questioned safety of Ayurvedic herbal preparations based on Harvard Medical
School report and created global problem on heavy metal content of Ayurvedic herbal preparations. It
was made clear that testing for safety and efficacy was crucial, and incorporating TRM pharmacopoeia
into officially endorsed health programmes was obviously emphasized. Clinical and scientific testing of
traditional remedies is very much highlighted in WHO consultative meetings. This scientific expertise
demanded and required to implement the process of clinical evaluation of TRM was greater than what
may be available on national levels. The World Health Organization posed a question in 2002, whether
an herbal medicine can be used clinically if no harm has been found after the use of that herbal medicine
for generations and there is no documentation of such an effect. For an answer to the question,
reference is made to an earlier WHO document published in which states "Absence of reported or
documented side effect is not an absolute assurance of safety of herbal medicine. However, a full range
of toxicology tests may not be necessary. Tests which examine effects that are difficult or even
impossible to detect clinically should be encouraged. Suggested tests include immunotoxicity,
genotoxicity, carcinogenicity and reproductive toxicity. It adds the following caveat, "only when there are
no documentations of long historical use of an herbal medicine or when doubts exist about its safety,
should additional tests be performed.
In addition, pharmaceutical interests were notoriously apathetic to drug development specific to health
issues or interests of the South. The clinical testing and intensive research and development required in
traditional medicine remained framed as an issue relevant to the population needs of the South, despite
any apparent fortuitous pharmacological discoveries for the North that may also result. In India there are
significant attempts made to validate Traditional Knowledge in terms of modern science. But
Harmonization and validation of the complex process of Ayurvedic therapeutics remain important. Novel
efforts like Ayugenomics aim to understand Ayurvedic concept of Prakruti from pharmcogenomics
perspective to provide a base for human classification, diagnostics and customized medicine. Projects like
AyuSoft aim to develop intelligent and interactive software based on Ayurvedic classics as a decision
support system. New analytical approaches like Herboprint use three-dimensional HPLC and attempt to
develop tools for activity-based standardization of botanicals. India needs a clear policy for such
Dr Danister L. Perera, Consultant (Ayurveda); danister@mobitelnet.lk
Seminar on Indigenous Medicine: Role of Chemists and Recent Advances: 2014.05.21 Page 5
integration without compromise on the strategies that are science-based. Efforts are needed to establish
and validate pharmacoepidemiological evidence regarding safety and practice of Ayurvedic medicines.
But Ayurveda is recognized as formalized and organized knowledge system which is comprised of
theories, principles and classical hypotheses becoming relatively scientific. Quality assurance and
standardization of Ayurvedic products must be based on principles and norms derived from Ayurvedic
ideologies and underlying theories. Traditional concept of customized or personalized medicine is now
getting obviously materialized through research outcomes of pharmacogenomics and
chronotherapeutics. Blockbuster model of pharmaceutical industry is now under pressure and socially
challenged with new developments of genomics pharmacology. Ayurvedic sector should be innovative to
harness principles behind pharmacogenomics which can be substantially materialized in traditional
medical modality of medicinal products.
Ayurvedic Quality assurance is mainly done in National Quality Control Laboratory of BMARI. Protocols
used for quality control are very much focused to determine physical and chemical parameters. Process
of quality control is practically productive when it is applied to single raw material specially plant sources.
But when it comes to finished products it needs a more complex laboratory equipment and apparatus
which can only be able to quantitatively describe quality of the product. Again the issue of qualitative
value still cannot be dictated in term of analytical chemistry. Scientific identification, marker compounds,
active ingredients and physical characteristics are very clearly understood and comprehensive by these
methods. But Ayurvedic products are mixture of tangible and intangible elements. Sometimes it includes
cosmic energy as well as spiritual forces as part and parcel of the medicine. In some cases medicine
contains purified poisonous or toxic substances which are not detectable in their wholesome form.
Efficacy is proven through patient oriented evidence based practice but not the safety in terms of
pharmacovigilance. Adverse Drug Reactions are not reported in a formal manner and no assessment has
done in terms of pharmacoepidemiology. Nevertheless a mechanism for quality assurance is in operation
basically to regulate commercial products in order to upkeep the sector-wide discipline. But there are still
anomalies and inconsistencies due to lack of human resources and technical facilities.
Suggested technical publications for further reference:
Mishra, L. C. (2003 ) Scientific basis for Ayurvedic therapies. CRC Press
WHO (1988) International Consultation on the Conservation of Medicinal Plants, Chiang Mai, Thailand,
21-27 March, Geneva: World Health Organization.
WHO (1996) Good Manufacturing Practices: supplementary guidelines for the manufacture of herbal
medicinal products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-
fourth report. 1996 (WHO Technical Report Series, No. 863), Geneva: World Health Organization.
WHO (1997) Guidelines for the assessment of herbal medicines. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Thirty-fourth report. 1996 (WHO Technical Report Series,
No. 863), Annex 11. Geneva: World Health Organization.
WHO (1998) Guidelines for the appropriate use of herbal medicines. Western Pacific Series No. 23.
Geneva: World Health Organization.
WHO (1998) Regulatory situation of herbal medicines: a worldwide review (document WHO/TRM/98.1).
Geneva: World Health Organization.
Dr Danister L. Perera, Consultant (Ayurveda); danister@mobitelnet.lk
Seminar on Indigenous Medicine: Role of Chemists and Recent Advances: 2014.05.21 Page 6
WHO (1991) WHO/DANIDA Intercountry Course on the Appropriate Methodology for the Selection and
Use of Traditional Remedies in National Health Care Programmes. Report of an Intercountry Course held
in Kadoma, Zimbabwe 1989 (No. TRM/91.1). Geneva: World Health Organization.
WHO (1996) Good Manufacturing Practices: supplementary guidelines for the manufacture of herbal
medicinal products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-
fourth report. (WHO Technical Report Series, No. 863), Annex 8. Geneva: World Health Organization.
WHO (1998) Quality control methods for medicinal plant materials. Geneva: World Health Organization.
WHO (1999) WHO monographs on selected medicinal plants Vol. 1 Geneva: World Health Organization
WHO (1999) WHO monographs on selected medicinal plants Vol. 2 Geneva: World Health Organization
WHO (1999) Traditional and Modern Medicine: Harmonizing the Two Approaches. A report of the
Consultation Meeting on Traditional and Modern Medicine: Harmonizing the Two Approaches, 22-26
November 1999 Beijing, China. Manila, WHO Regional Office for the Western Pacific
WHO (2000) General guidelines for methodologies on research and evaluation of traditional medicine.
Geneva: World Health Organization.
WHO (2001) Legal status of traditional medicine and complementary/alternative medicine: a worldwide
review (document WHO/EDM/TRM/2001.2). Geneva: World Health Organization.
WHO (2002) WHO traditional medicine strategy 2002 - 2005 (document WHO/EDM/TRM/2002.1).
Geneva: World Health Organization.
WHO (2003) WHO Guideline on good agricultural and collection practices (GACP) for medicinal plants.
Geneva: World Health Organization.
WHO (2003) Proceedings of the International Meeting on Global Atlas of Traditional Medicine, 17-19
June 2003, Kobe, Japan
WHO (2003) WHO Guideline on good agricultural and collection practices (GACP) for medicinal plants.
Geneva: World Health Organization.
WHO (2004) WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems.
Geneva: World Health Organization.
WHO (2004) Guidelines on Developing Consumer Information on Proper Use of Traditional,
Complementary and Alternative Medicine. Geneva: World Health Organization.
WHO (2004) Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region, Regional
Office for South-East Asia, New Delhi, SEA-Trad. Med.-82
WHO (2007) WHO guidelines for assessing quality of herbal medicines. Geneva: World Health
Organization.
WHO (2007) WHO monographs on selected medicinal plants Vol. 3 Geneva: World Health Organization
WHO (2009) WHO monographs on selected medicinal plants Vol. 4 Geneva: World Health Organization