Lack of proper evaluation and standardised analytical methods of currently marketed herbal products ijrpp

____________________
* Corresponding author:
Lokesh VS Bontha
Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, UCSI University, No:1, Jalan Menara
Gading, Taman Connaught, Cheras, POSKOD 56000, Kuala Lumpur, Malaysia
E-mail address: lokeshb@ucsi.edu.my / bvslk71@
Available Online at: www.ijrpp.com
AN OVERVIEW ON THE L
STANDARDISED ANALYTI
MARKETED HERBAL PROD
*1
Lokesh V S Bontha
Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences,
UCSI University, Kuala Lumpur, Malaysia.
__________________________________________
ABSTRACT
Traditional medicines have been used in chronic and potential life
by the young, aged people for health maintenance. Herbal therapy is famous as a traditional medical practice,
based on the use of plants and plant extracts. World’s multicultural society is composed of various communities
with the practice of traditional medicine, which is influenced by mostly usage of medicinal herbs and herbal
products along with synthetic drugs for major diseases. In this cur
emphasize the lack of proper evaluation and standardised analytical methods for medicinal herbs and herbal
products. It is also suggested in this review on handling safety issues and concerns of herbal product
larger community. Chronic usage of these adulterated traditional medicines which contain synthetic drug
contaminants, steroids and heavy metals may result in secondary health complications, deficiencies, adverse herb
interactions and herb-drug interactions leading to complications of regular body functions. It is recommended to
estimate the active drug content uniformity based on sustainable harvesting of selected local sources of herbs and
evaluating the current trends of qualitative and quanti
safety. It is also suggested to compare and correlate with standardized methods of regular time to time variations
of active growing herbs, and a continuous research has to be conducted to impart r
good manufacturing practices and quality control of herbal products for appropriate product registration and
licensing. This review showed important reasons to motivate the regulatory authorities in improving traditional
health care policies and research methodologies on quality, safety by appropriate or more suitable means of
evaluation of herbal medicinal products. It is concluded that the national integrated research program may be
conducted in collaboration with local sup
medicines, and it may be reassessed by evaluating the clinical trials on indigenous traditional medicinal plants and
herbal products to ensure their safety and efficacy.
Key words: Traditional medicine, safety, efficacy, qualitative and quantitative aspects, regulations, ethical
practices
INTRODUCTION
Herbal therapy, a traditional medical practice or
medicine treatment is based on the use of
plant extracts. It is also known as phytotherapy
scope of herbal medicine is sometimes extended to
include fungal and bee products, as well as minerals,
shells and certain animal parts. Pharmacognosy
the study of medicines derived from natural sources.
Gading, Taman Connaught, Cheras, POSKOD 56000, Kuala Lumpur, Malaysia
bvslk71@yahoo.com
Available Online at: www.ijrpp.com Print ISSN: 2278 - 2648
Online ISSN: 2278 - 2656
(Review
AN OVERVIEW ON THE LACK OF PROPER EVALUATION AND
STANDARDISED ANALYTICAL METHODS OF CURRENTLY
MARKETED HERBAL PRODUCTS: A REMEDIAL APPROACH
Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences,
Lumpur, Malaysia.
_________________________________________________________________
Traditional medicines have been used in chronic and potential life-threatening diseases, and they are widely used
lant extracts. World’s multicultural society is composed of various communities
products along with synthetic drugs for major diseases. In this current review, the author has made an attempt to
products. It is also suggested in this review on handling safety issues and concerns of herbal product
interactions leading to complications of regular body functions. It is recommended to
evaluating the current trends of qualitative and quantitative aspects of active drugs in selected herbs and their
of active growing herbs, and a continuous research has to be conducted to impart regulations on ethical practice,
lth care policies and research methodologies on quality, safety by appropriate or more suitable means of
conducted in collaboration with local suppliers/distributors on the safety issues and the legal supply of herbal
herbal products to ensure their safety and efficacy.
Traditional medicine, safety, efficacy, qualitative and quantitative aspects, regulations, ethical
a traditional medical practice or folk
treatment is based on the use of plants and
phytotherapy. The
scope of herbal medicine is sometimes extended to
products, as well as minerals,
Pharmacognosy is
the study of medicines derived from natural sources.
Traditional medicines have been used in chronic and
potential life-threatening diseases, and they are
widely used by the young, aged people for health
maintenance. Evaluation methods of these
traditional medicines and their safety, efficacy are
the major concerns of the health care professionals.
World’s multi-cultural society is composed of
communities with the practice of traditional
medicine, which is influenced by mostly extensive
usage of medicinal herbs and herbal products along
with synthetic drugs for major diseases. Herbal
International Journal
Research in Pharmacology and
Pharmacotherapeutics
79
(Review article)
TION AND
NTLY
ROACH.
_______________________________
threatening diseases, and they are widely used
lant extracts. World’s multicultural society is composed of various communities
rent review, the author has made an attempt to
products. It is also suggested in this review on handling safety issues and concerns of herbal product usage on a
interactions leading to complications of regular body functions. It is recommended to
tative aspects of active drugs in selected herbs and their
egulations on ethical practice,
lth care policies and research methodologies on quality, safety by appropriate or more suitable means of
pliers/distributors on the safety issues and the legal supply of herbal
Traditional medicine, safety, efficacy, qualitative and quantitative aspects, regulations, ethical
cines have been used in chronic and
threatening diseases, and they are
widely used by the young, aged people for health
maintenance. Evaluation methods of these
traditional medicines and their safety, efficacy are
ealth care professionals.
cultural society is composed of various
communities with the practice of traditional
medicine, which is influenced by mostly extensive
usage of medicinal herbs and herbal products along
diseases. Herbal
International Journal of
Research in Pharmacology and
Pharmacotherapeutics

80
Lokesh V S Bontha et al / Int. Jour. of Res. in Pharmacology and Pharmacotherapeutics Vol-1[1] 2012 [79-84]
www.ijrpp.com
medicines/extracts are being dispensed in all
corners, especially in rural areas by unauthorized
practitioners without being evaluated for clinical
studies of the active herb. These practitioners
develop a communalism without adhering to the
legislation and ethics. Chronic usage of these
adulterated traditional medicines which contain
synthetic drug contaminants, steroids and heavy
metals may result in secondary health complications,
deficiencies, adverse drug interactions and herb-drug
interactions leading to complications of regular body
functions. Research community involved in-vitro-in-
vivo correlation (IVIVC) studies has addressed and
deliberated on safety issues, noncompliance to
guidelines.
Herbal products are most widely used in
subcontinent and Middle East Asian countries,
especially India and China as largest producers of
herbal products widely sold all over the world. Most
of the herbal products are used as alternative and
complementary medicine in common and life-
threatening diseases. Majority of herbal products are
released into the market based on their
standardization and validation of the active herbal
molecules supplied by individual manufacturers
controlled by regulatory authorities of their
respective countries. World Health Organization
(WHO) has validated and published specifications
and monographs on certain medicinal plants based
on their safety use and patient compliance. United
States Food and Drug Administration (USFDA)
controls and monitors herbal drugs, and their
formulations entered into the largest United States
pharmaceutical market. USFDA agencies conduct
workshops, seminars and conferences to debate on
the quality standards, safety and efficacy of herbal
products since for the past decades.
LITERARURE BACKROUND AND
REVIEWABLE EVIDENCE
Traditional medicines are recognized as a way about
potential future medicines. In 2001, researchers have
identified 122 compounds used as mainstream
medicines, which were derived from ethnomedicinal
plant sources. All these compounds were used in the
same or related manner for the practice of
traditional medicine. [2]
Many plants synthesize substances that are useful
for the maintenance of health in humans and other
animals. These include aromatic substances, most of
which are phenols or their oxygenated phenols and
their substituted derivatives such as tannins. Many
secondary metabolites and complex organic
molecules have been isolated and 10% of active
compounds have been estimated. In many cases,
substances such as alkaloids serve as plant defense
mechanisms against predation by microorganisms,
insects, and herbivores. Many of the herbs and spices
used by humans to season food yield useful
medicinal compounds.[3][4]
Similarly, to prescription drugs, a number of herbs
are thought to be likely to cause adverse effects [5]
.
Furthermore, "adulteration, inappropriate
formulation, or lack of understanding of plant and
drug interactions have led to adverse reactions that
are sometimes life threatening or lethal.[6]
.
Many of the pharmaceuticals currently available to
physicians have a long history of use as herbal
remedies, including opium, digitalis, and cinchona
alkaloids. The World Health Organization (WHO)
estimates to about 80% of the world's population
presently uses herbal medicine due to as a
traditional and home remedial practices for certain
aspects of their primary health care. Synthetic
pharmaceuticals are prohibitively expensive for most
of that[8] type of world's population which is not
cost effective for their maintenance of
primarypopulation,re [7]
in comparison to the herbal
medicines, which can be grown from the available
raw seeds from nature for little cost.
In addition to the use in the developing world, herbal
medicine is used in industrialized nations by
alternative medicine practitioners such as
naturopaths. In 1998, a survey of herbalists in the
United Kingdom is done, and it was found that many
herbs recommended by them were used traditionally
but not been evaluated in clinical trials. [9] In 2007,
another survey has been conducted in Australia on
western herbalists tend to prescribe the liquid herbal
combinations of herbs rather than tablets of single
herbs. [10]
The search and use of drugs and dietary
supplements are derived from plants has been
increased practice in recent years. The
pharmacologists, microbiologists, botanists, and
natural-products chemists are conducting extensive
research on phytochemicals to discover new lead
compounds that could be developed for treatment of
various diseases. A to the World Health Organisation,
approximately 25% of modern drugs used in the
United States have been derived from plants. [11]
Among the 120 active compounds currently isolated
from the higher plants and widely used in modern
medicine today, 96 active compounds show a
positive correlation between their modern
therapeutic use and the traditional use of the plants
from which they are derived.[2]
Atleast 7,0000 active
compounds in the modern pharmacopoeia are
derived from plants.[12]
The standards and tests are conducted in large scale
for herbal medicines in large-scale, and they are
randomized with double-blind tests. In 2004, the U.S.
National Centre for Complementary and Alternative
Medicine (NCCAM) of the National Institutes of
Health(NIH) began funding for clinical trials on the
effectiveness of herbal medicine.[13]
In a In 2010, a
survey of 1000 plants for their clinical evaluations
has been conducted, and it was found that clinical
trials published evaluating their pharmacological
activities and therapeutic applications for 156

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plants. While for 120 plants, there were no
substantial studies of their properties even though
all plants are available in the Western market.[14]
Many herbs have shown positive results in-vitro,
animal modelled small-scale clinical tests[15], but
many studies on herbal treatments have also found
negative results.[16]
The quality of the trials on herbal
remedies is highly variable and many trials of herbal
treatments have been found to be of poor quality,
with many trials lacking an intention to treat
analysis or a comment on whether blinding was
successful.[17]
The few randomized, double-blind tests
that receive attention in medical publications are
often questioned on methodological grounds or
interpretation. Likewise, studies published in peer-
reviewed medical journals such as Journal of the
American Medical Association receive more
consideration than those published in specialized
herbal journals.
In literature, many articles have been published in
alternative medicine journals with non-impact factor
on more studies with positive results than negative
results. Those trials found with positive results were
of lower quality than trials found with negative
results. Equal numbers of trials with positive and
negative results are published in high-impact factor
mainstream medical journals. In high-impact
journals, trials finding positive results were also
found to have lower quality scores than trials finding
negative results.[16]
Another study reported that some
clinical studies of herbal medicines were not inferior
to similar medical studies.[18]
However, this study
used a matched pair design and excluded all herbal
trials that were not controlled, did not use a placebo
or did not use random or quasi random assignment.
Herbalists criticize mainstream studies on the
grounds that they make insufficient use of historical
usage, which has been shown useful in drug
discovery and development in the past and present [2]
to maintain that tradition, which can guide the
selection of factors such as optimal dose, species,
time of harvesting and target population.[19]
The issue of regulation is an area of continuing
controversy in the European Union and United States
of America. Some herbalists do not agree with the
level of safety testing as xenobiotic or single active
compound in an artificially active form for
traditional remedies with a long history of use. On
the other hand, others are in favor of legally
enforced quality standards, safety testing and
prescription by a qualified practitioner. Some
professional herbalist organizations have made
statements to enforce a category of regulation for
herbal products.[21]
Others have agreed with the need
for more quality testing. However, it can be managed
through reputation without government intervention
with the legal status of herbal ingredients by a
particular country [22]
.In the EU, herbal medicines are
now regulated under the European Directive on
Traditional Herbal Medicinal Products (EDTHMP). In
the United States, most herbal remedies are
regulated as dietary supplements by the Food and
Drug Administration (FDA). Legal manufacturers of
herbal products falling into this category are not
required to prove the safety or efficacy of their
products unless the FDA may withdraw a product
from the market, which may be proven harmful.[23][24]
The National Nutritional Foods Association, the
industry's largest trade association, has run a
program since 2002, examining the products and
factory conditions of member companies, giving
them the right to display the GMP (Good
Manufacturing Practices) seal of approval on their
products.[27]
Some herbs, such as Cannabis, are
banned in most countries. Since 2004, the sales of
ephedra as a dietary supplement is also restricted in
the United States by the Food and Drug
Administration.[25]
It is also subjected to Schedule III
restrictions in the United Kingdom.
In January 2008, the Botanic Gardens Conservation
International (representing botanic gardens in 120
countries) stated that "400 medicinal plants are at
risk of extinction, from over-collection and
deforestation, threatening the discovery of future
cures for the disease." These included Yew trees (the
bark is used for cancer drugs, paclitaxel); Hoodia
(from Namibia, source of weight loss drugs) half of
Magnolias (used as Chinese medicine ancient times
to fight cancer, dementia and heart disease) and
Autumn crocus (for gout). The group also found that
5 billion people benefit from traditional plant-based
medicine for health care[26]
. Some herbalists are aware
of this problem and substitute least concern species
as a result.
In 2005, the prednisolone is detected in the
traditional and complementary medicines marketed
in Malaysia for elderly people29
. The article has been
published in reputed Malaysian medical journal. It
has been clearly detected the presence of steroids in
herbal products. This has been reflected clearly to
look into the approval procedure and screening
methods of herbal products for general use for their
safety. Even though National Regulatory Board (NRB)
has monitored intermittently on all marketed herbal
preparations for their safety, however, the screening
methods are not scientifically sufficient to assure the
quality and safety of herbal products.
PROBLEMS ENCOUNTERED FOR
PROPER EVALUATION AND
STANDARDIZED ANALYTICAL
METHODS OF ACTIVE HERBS AS
WELL AS ITS PRODUCTS
Guidelines on Traditional Medicines
In 2002, WHO has conducted a Traditional Medicine
Strategy (TMS) and released standard guidelines and
herbal monographs to be followed by herbal

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practitioners and herbal manufacturers on the
quality control of herbal preparations produced and
distributed into the world market. The key
challenges in the report on traditional medicines
include (1) on National policies and legal frame work;
(2) Safety, efficacy and quality; (3) Access to the
availability and affordability to the poor populations;
(4) Promoting the therapeutically sound use of
traditional medicine by providers and consumers28
.
Safety concerns on Traditional Medicine
There are serious concerns over marketed herbal
formulations, especially on their safety use and
patient compliance. Some of the herbal preparations
have been approved and incorporated in
international pharmacopoeias/herbal compendium
to assure the quality of herbal products from batch
to batch production and ethnobotanical variations of
the active constituent in various active medicinal
herbs. The biomedical science has been developed
enormously, and new technology generates huge
evidence based data to support the quality of new
molecules released into the market. (1) One major
problem is identified as herbal drugs are complex
molecules with their difficulty to identify and
quantify with modern analytical techniques of
science and technology. It is a tedious process of
analytical method development of multi component
analysis by modern analytical techniques like High-
Performance Liquid Chromatography (HPLC), Gas
Chromatography (GC) and High Performance Thin
Layer Chromatography (HPTLC) etc.
Multiple pharmacological effects of
Traditional Medicine
Second major problem is identified as multiple
pharmacological effects of traditional medicine
mismatches with the dose-response correlations of
the active herbs which are in turn related to the
mixture of active constituents present in the active
herb. It is very difficult to separate and assess their
specific pharmacological effect of the individual
active constituent as well as their toxicity, herb
interactions and herb-drug interactions to assess
their safety and efficacy. Modern separation
techniques help to separate the active constituents
in active herb, however, identifying the individual
active constituent is time-consuming and a challenge
to the modern separation technology due to their
closely related chemical nature within the active
herb. This complicates the dose-response variations,
analytical method optimization and analytical
method validation to assure the quality of active
compounds in the herbal preparations. Moreover, it
has been unknown for major/multiple minor
pharmacological effects of a single active compound
or multiple active compounds, which are needed in
larger doses to reach the pharmacological
effectiveness to standardize the dose-response
process. The ethnobotanical and environmental
variations in content of the active compounds,
various pesticides and other toxic chemicals used in
the agricultural process of the growing active herbs
do not assure the content uniformity, safety, efficacy
and quality of the active herbs.
Dose uncertainty of Traditional Medicine
The dose of active herb powder in a herbal
formulation is an outstanding issue for herbal
treatments, while most medicines are heavily tested
to determine the most effective and safest dosage
especially in relation to the body weight, age and
medical history of a patient. There are fewer
varieties of dosages for various herbal treatments on
the market. Furthermore, herbal medicines are
consumed in whole form which cannot guarantee a
consistent dose of drug quality from a conventional
pharmacological perspective, since certain samples
may contain more or less of a given active
ingredient.
Quality of Traditional medicinal
products
Third major problem has been the lack of routine
quality screening and good stability indicating
methods for active compounds in active herb. The
tedious process of harvesting, collecting, storing
huge bulky medicinal herb is a major concern for all
traditional medicinal local or international regulatory
agencies. The isolation of active compounds from an
active herb involved with toxic solvents and assuring
their absence in the final active herb powder or
formulation is a major concern on the lack of
consistent methods for proper extraction by modern
analytical separation and screening techniques. This
problem is continued to be prevailing in the
production process of formulations to all herbal
products, which are released into the market without
proper qualitative and quantitative estimation of the
active compound in the active herb especially for
herb-herb interaction, herb-excipient interaction. The
stability and impurity profiles of the active
compounds have not also been evaluated before they
release into the market.
Substranded and adulterated marketed
herbal products
Current marketing samples are analysed for the
presence of synthetic adulterants to show mixed
pharmacological response and patient compliance
without being handling the symptoms. Local and
international regulatory testing laboratories do
performed for the presence of heavy metals and
steroids only. Most of the herbal products for
general use only are being approved by authorities.
Any herbal products with anticancer properties
could not be evaluated for their cytotoxicity, side
effects or any other toxicological responses. Most of
herbal products do not comply with the
incompatibility studies herb-herb, herb-drug and
herb-drug excipient interactions.

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Herbal products are released into the market without
proper validation, just based on the basis of brand
market response. The liberty of selling herbal
compounds in liquid or oral dosage forms by
unauthorized and traditional practitioners being
inspected or validated by local Ministry of Health,
and not being met the requirements of WHO
monographs/herbal pharmacopoeia / USFDA
regulations/ ICH guidelines under safety, efficacy,
and quality control/quality assurance of widely used
medicinal plants.
A REMEDIAL APPROACH FOR THE
CURRENT AND FUTURE
GENERATION PERSPECTIVE
Modern analytical methods
Modern preparative and analytical UPLC/HPTLC
techniques allowed developing several methods of
standardization of active herb to identify the active
compound either by the ratio of raw materials to the
solvent or method of standardization of a single
active compound. However different specimens of
even the same plant species may vary in the
concentration of the active compound being isolated.
For this reason, thin layer chromatography is used
by herbalists to assess the content of their active
compounds before use approximately.[20]
Standard
qualitative and quantitative tests for heavy metals,
foreign steroids, organic volatile impurities, traces of
chlorides, sulphates, tests for synthetic and natural
adulterants, biochemical tests for the presence of
proteins, minerals, carbohydrates, vitamins,
hormones, 3 and 6 fatty acids, synthetic
flavouring agents, preservatives and other added
organic chemicals are to be screened in every herbal
product from the active herb to herbal product stage
during production to assure the quality and safety of
a herbal product. Concurrent validation has to be
conducted from time to time variations of active
compound in the active herb. Analytical methods
have to be developed to determine the active
compounds in biological fluids to assess the active
compound concentration in the blood for
pharmacokinetic and pharmacological screening.
Phytochemical analysis, biological and
Pharmacological screening methods
Thorough screening of animal studies is
recommended for active herb/ principal active
constituents for evaluating and standardizing the
pharmacological mechanism of action, docking
studies, chemical structure elucidation, and
quantitative structure-activity relationship studies by
using modern and sophisticated techniques, QSAR
software and bio informatics. Chemometric
techniques are particularly used in analytical
chemistry and metabolomics, and the development
of improved chemometric methods of analysis
continue to advance the state of the art in analytical
instrumentation and methodology for an active herb
to identify individual and complex chemical
constituents. Genomics, proteonomics and molecular
modelling assist to solve the large-scale study of
proteins, genetic compatibility, particularly their
structures and functions at macromolecular and
gene level. Proteins are vital parts of living
organisms, as they are the main components of the
physiological and metabolic pathways of cells and
their sensitivity, selectivity and specificity to
principal compounds in an herbal preparation need
to be studied. These studies would help to evaluate
the potency, lead compound-receptor interaction,
drug loading dose, compatibility, adverse herb
reactions and herb tolerance.
Pre-clinical studies
The analytical method development of natural
products needs to be high lightened for active
herb/herbal preparations, whether they may be used
for general usage or for major life-threatening
diseases. Clinical trials may be suggested on selected
marketed herbs and herbal products for their
quality, toxicity, safety and efficacy. Good stability
indicating assays need to be developed to assess and
ensure safety. National and international drug laws
and drug ethics shall be applied to all herbal
products and sold under scheduled and controlled
national and international laws of drug ethics.
CONCLUSION
In our review, brief methodologies are suggested for
standardizing the traditional medicinal herbs and
marketed herbal preparations for evaluating their
quality and safety. In addition, the use of modern
technology and sophistication is suggested to
evaluate the quality and safety of herbal medicines.
A survey may be conducted by local regulatory
authorities on the ethical and non-ethical issues,
legal and illegal traditional practitioners, distributors
and suppliers to impart the regulatory requirements
according to national drug laws and ethics. They may
impart regulations on the ethical practices, good
manufacturing practices, quality control of herbal
products for product registration and licensing.
Herbal researchers and ethical practitioners may
conduct various counselling sessions on the effective
usage of herbal medicines. This review shows
important reasons to motivate the researchers by
collaborating with regulatory authorities to improve
the health care and research methodologies on
quality and safety by appropriate means of
evaluation of herbal medicinal products. It is
concluded that the national integrated research
program may be conducted in collaboration with
local suppliers/distributors on the safety issues and
the legal supply of herbal medicines, and it may be
reassessed by evaluating the clinical trials on
indigenous traditional medicinal plants and herbal
products to ensure their safety and efficacy.

84
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