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An International Conference on
Challenging and Emerging Dimensions in Medicinal/Herbal Plants and their Products: A Global
Perspective; 26-28 November 2010; Chennai Trade Centre, Chennai, India
Technical Session-09
Traditional Medicine
173
An International Conference on
Challenging and Emerging Dimensions in Medicinal/Herbal Plants and their Products: A Global
Perspective; 26-28 November 2010; Chennai Trade Centre, Chennai, India
Quality control and standardisation of traditional
medicine/herbal drugs
M.J. Nanjan
Director, TIFAC CORE HD, JSS College of Pharmacy, Ootacamund-643001
e-mail : mjnanjan@hotmail.com
Traditional medicine may be defined as diverse health practices, approaches, knowledge and beliefs
incorporating plant, animal and/or mineral based medicines, spiritual therapies, manual techniques and exercises
applied singularly or in combination to maintain the well being as well as to treat, diagnose or prevent
illness. Herbal drugs, on the other hand, may be defined as finished, labeled medicinal products that contain
as active ingredients, aerial or underground parts of plants or other plant material, or combination thereof,
whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty acids, essential
oils or any other substances of this nature. Herbal medicines may also contain excipients in addition to active
ingredients. But the problem with Traditional medicine/Herbal dugs is that the method of their action is not
understood in terms of modern science. They often consist of mixtures of different substances. It is difficult,
therefore, to subject them to modern scientific methods of analysis or to meet the regulatory and approval
mechanisms designed for single molecules of modern medicine.
It is estimated that the world market for traditional medicine and herbal drugs is $ 62 billion and this market
is growing at a rate of 20% per annum. Further, WHO has forecasted a global market of $ 5 trillion by the
year 2050. India has one of the 12 mega biodiversities in the world with an estimated 47 thousand plant
species. India, therefore, has a tremendous potential to become a world leader in Traditional medicine/Herbal
drugs. Unfortunately, our share is only about 2% of the global market, in spite of the hub of our traditional
medicine like Ayurveda, Siddha, etc. This is because our products are not backed by rigorous scientific
studies to establish their quality, safety, efficacy and standards.
What is quality of traditional medicine/herbal drugs and how do you assess it? In the Indian context, quality
seems to mean different thing to different people. Some equate quality with efficacy and potency. Others
focus on the relationship between quality and safety and still others focus on the marker content. Generally,
the consensus on herbal drugs has been focused on the issue of marker content. The over emphasis on marker
content, however, has been a boon for unethical businessmen. Potency and efficacy are two different aspects.
Efficacy is a qualitative term defined as the power to produce an effect whereas potency is a quantitative
term defined as the amount of the active ingredient or drug required to produce a therapeutic effect. If
chemical assays are used to measure potency, a product may be extremely potent but fail to be efficacious
if a sub therapeutic dosage schedule is used, if it is not bioavailable, if it is neutralized by the other
substances in the body and if the patients constitution significantly differs from that an average person
(genetic, environmental and idiosyncratic factors). The presence the predetermined amount of marker(s)
compound(s) does not guarantee the potency of the product. Potency requires biological assessment of a
product and cannot be determined solely by marker or active compound measurements.
There was a time when life was simple for both pharmacist and physician. When a drug was drug and plant
TS-9/LP-1
174
An International Conference on
Challenging and Emerging Dimensions in Medicinal/Herbal Plants and their Products: A Global
Perspective; 26-28 November 2010; Chennai Trade Centre, Chennai, India
was a plant. This changed in 1994 when the US Congress proposed the Dietary Supplement Health and
Education Act (DSHEA) wherein they brought the idea of standardization of herbal products. Standardization
of herbal products is believed to guarantee therapeutically effective doses of stable, active principles that
maintain consistency from batch to batch. Translating this concept to herbal drugs is not as simple as it may
appear because the content of botanical preparations depend on growing conditions, climate, soil quality,
time of harvest, drying, powdering, extraction, stabilization, etc.
The single most important factor which is standing in way of Indian Traditional Medicine/Herbal Drugs
being widely accepted, especially in developed countries is the non availability or inadequacy of standards
to check the quality of our products. Traditional people/Herbalists believe standardization is chemicalization
or pharmaceuticalization . They say should nature be standardized and should we not allow nature to continue
its role herself.But then, standardization seems to be a complex and controversial subject. For some it means
manufacturing a product to contain the specific amount of the herb in a dosage unit, for others it means
manufacturing a product to contain a certain marker compound(s) to a specified level. For still others, it is
consistent manufacturing product. Scientific validation should be the key to standardization. The product
should be therapeutically effective as claimed. Toxicological studies should have been done on the product
to check its safety and the product should be free from harmful contaminants like, heavy metals, microbials,
pesticides, etc. The key to achieve this is to,
Carry out well designed, randomized and double-blind placebo-controlled clinical trials on humans
To determine the activity of the product by pharmacological and clinical method and then to prepare a
qualitative and quantitative chemical profile of the all significant chemical constituents by HPLC/GC-MS
and other methods to established phyto equivalence
To establish the dosage form composition by carefully selecting the excipients and other diluents and
To establish the bioavailability of at least the major constituents
According to WHO standardization refers to the whole body of information and controls required to produce
a formulation of reasonable consistency. This is achieved through minimizing the inherent variation in the
composition of the natural products through quality assurance practices applied to medicinal plant growing,
extraction and formulation development.
Standardization can serve a number of purposes including batch to batch consistency, correct amount of the
extract/marker per dosage unit and positive control to indicate the possible loss or degradation during
manufacturing. Standardizing Traditional/ Herbal products is challenging because every step, right from
botanical identity, botanical purity, assessing potency and designate markers and availability of reference
materials, is crucial.
Whether in the future highly active, safe and causality based traditional medicine/herbal drug will be able
to replace modern drugs depends on the level of evidence-based therapeutic efficacy is achieved for herbal
drugs. It will also be necessary to find scientific rationale for the fact that many herbal drugs usually when
applied in low doses exhibit no immediate pharmacological or therapeutic effect, but achieve their optimal
efficacy only after long term treatment.
175
An International Conference on
Challenging and Emerging Dimensions in Medicinal/Herbal Plants and their Products: A Global
Perspective; 26-28 November 2010; Chennai Trade Centre, Chennai, India
As traditional medicines/herbal drugs continue to increase slowly their popularity, it has become vital to
educate medical and scientific establishments and show that there are some features which are unique to this
medicine which contribute to, both efficacy and safety. One of this is the concept of synergy in that a plant
extract is more than sum of its parts. Further research is required to prove that synergy is a true phenomenon
to be appreciated and utilized for therapeutic benefits. We must also consider what the drug law stipulates
in terms of guaranteeing the quality, safety and effectiveness of traditional medicine/herbal drugs. These may
differ from country to country, but a global consensus exists at least on a couple of points, namely;