- an Overview

Herbal Medicine
Chandra Teja U
KVSR Siddhartha College of Pharmaceutical Sciences
Vijayawada 10
By
The Current and Future Scenario of
Department of Pharmaceutics
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Herbal Medicine (or "Herbalism") is the use of plants for medicinal
purposes, and the study of such use. The scope of herbal medicine is
sometimes extended to include fungal and bee products, as well as
minerals, shells and animal parts.

Modern medicine recognizes herbalism as a practice that is not
strictly based on evidence gathered using scientific principles.

However, modern medicine makes use of many plant derived
compounds as the basis for pharmaceutical drugs, and phyto-
therapy works to apply modern standards of medicine to herbs and
medicines that are derived from natural sources.
Introduction
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Herbal Vs Conventional Systems of Medicine
Although superficially similar, herbal medicine & conventional
pharmacotherapy have three important differences
Use of Whole Plants - Herbalists generally use un-purified plant extracts
containing several different constituents. It is claimed that these can work
together synergistically and that the overall toxicity is reduced in this
way (buffering).
Herb Combining - Often several different herbs are used together.
Practitioners say that the principles of synergy and buffering apply to
combinations of plants. This contrasts with conventional practice,
where polypharmacy is generally avoided whenever possible.
Diagnosis - Herbal practitioners use different diagnostic principles from
conventional practitioners, mostly by observing the symptoms.
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The pharmacological treatment of disease with the use of herbs have
been the basis for medical systems since the dawn of human
civilization.

Methods of traditional healing throughout the world commonly used
herbs as part of their treatment.

The ancient systems of medicine that are majorly based on herbal
medicine and are most popular today are

Ayurveda (Ancient Indian Medicine) and

Chinese Medicine
A look into the History
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Ayurveda (Knowledge of Life) or Ayurvedic Medicine is a system
of traditional medicine native to the Indian subcontinent known
since time immemorial.
According to some sources about 80 percent of people in India still
use some form of Ayurvedic medicines.
The oldest known Ayurvedic texts are
The Surutha Sahit (majorly on surgery) &
The Charaka Sahit (on General medicine)
These are the classical Sanskrit texts that are foundational and
formally compiled works of Ayurveda.
Ayurveda includes diet and herbal remedies, with emphasis on the body,
mind and spirit in disease management.
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Traditional Chinese Medicine is a broad range of medicine
practices that were developed in China from ancient times, and
include various forms of herbal medicine, acupuncture, massage,
exercise, and dietary therapy.

In over 12 000 items used by traditional healers, the primary
source of remedies is botanical.

Traditional Chinese medicine is still in common use in China.
About 5000 traditional remedies are still available in China and
they account for approximately one fifth of the entire Chinese
pharmaceutical market.
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Ancient Greek and Roman systems of Medicine
In Ancient Greek, many components were considered intertwining
the spiritual with the physical. They believed that illnesses were
divine punishments and that healing was a gift from the Gods.
Specifically, the theories and ideologies included the humors
(blood, yellow bile, black bile and phlegm), gender, geographic
location, social class, diet, trauma, beliefs, and mind set.
Medicine in ancient Rome was much like in ancient Greek Ancient
Roman medicine included a number of specializations such as internal
medicine, ophthalmology and urology. Public health was encouraged
by the government at the time; they built bath houses, aqueducts, etc.
However, the Romans did not fully understand the involvement of
germs in disease.
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Renaissance & the birth of Modern Medicine
Scientists and thinkers began to shake loose from the traditional views
that governed medicine. The focus of treatments was no longer a
divinely ordained natural balance.
The Renaissance was a great period of intellectual growth and artistic
development in Europe.
The scientific method is applied to medicine
Knowledge advanced through the scientific method-
conducting experiments, collecting observations, reaching to
conclusions.
Information was disseminated by means of an important new
technology-printing.

The roots of scientific medicine were set.
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The Current Status
of
Herbal Medicine
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Herbal Medicines have stood the test of time for their safety, efficacy
and lesser side effects.
Herbs today are being increasingly used to treat all kinds of disorders
from mild cases like common cold to serious diseases like cancer.

Many of the modern medicines are produced indirectly from
medicinal plants. It is often noted that over 25% of all drugs
prescribed today come from plants.

Nitrogen-containing alkaloids have contributed the largest number
of drugs to modern pharmacopoeia, ranging in effects from anti-
cholinergics (atropine) to analgesics (opium alkaloids) and from
anti-parasitics (quinine) to anti-neoplastics (Taxol, vinblastine and
vincristine).
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In spite of the fact that a vast majority of the drugs in
pharmaceuticals are derived from Natural Sources (mostly
Plants),
The demand for
herbal products as such
is increasing progressively
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Herbal Products are
Finished labelled products that contain active ingredients such as
Aerial or Underground parts of a plant or other plant material or
combinations thereof, whether in crude state or as plant preparations
(As defined by WHO) .
These are classified as
Phytomedicines or Phytopharmaceuticals sold as Over-The-
Counter (OTC) products in modern dosage forms such as Tablets,
Capsules & Liquids for oral use.

Dietary Suppliments containing Herbal Products, also called
Nutraceuticals available in modern dosage forms.

Herbal Medicines consisting of either Crude, Processed or Semi
Processed Medicinal Plants.
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Herbal Medicine is on the Raise
The US herbal medicine market is about $4 - $8 billion now.
The herbal medicine market in the countries of the European
Union is over $ 20 billion now.
The market in Germany is about $ 3 billion, France $ 1.6 billion
and Italy $ 0.6 billion.
A marked increase in their demand is being observed from the last
few decades
Incidentally in Germany and France, herbal extracts are sold as
prescription drugs and are covered by national health insurance.
Global Herbal Supplement Market To Reach $107 Billion By 2017
says a report from Global Industry Analysts
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Reasons adults in the US use Herbal Medicine
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Herbal medicine scenario in I ndia
The turnover of herbal medicines in India as classical formulations
and other forms of Ayurveda, Unani and Siddha systems of medicine
is about $ 1 billion with an export of only about $ 80 million.

Psyllium seeds and husk, castor oil and opium extract alone account
for 60% of the exports.

The revenue on export of herbal medicines from India is negligible
as 80% of the exports are of crude drugs and not finished
formulations, despite the fact that the country has a rich traditional
knowledge and heritage of herbal medicine.
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4 of the 10 most widely selling herbal medicines in developed countries,
namely preparation of Ocimum sanctum, Allium sativum, Aloe
barbadensis and Panax species are available and exported from India.
Panax ( all Heal in greek)
Allium sativum Aloe barbadensis
Ocimum sanctum
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Herbal medicine scenario in I ndia (contd.,)
India is one of the 12 mega biodiversity centres having
over 45,000 plant species. Its diversity is unmatched due to the presence
of 16 different agro-climatic zones, 10 vegetative zones and 15 biotic
provinces. Our country has a wealth of fungi, algae and other micro-
organisms.

About 1500 plants with medicinal uses are mentioned in ancient texts
and around 800 plants have been used in traditional medicine.

In spite of this, no efforts have been made towards the development of
agro-technologies for the organized farming and use as authentic
materials in herbal medicines for better economic gains.
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The major traditional sector pharmas, namely Himalaya, Zandu,
Dabur, Hamdard, Maharishi, etc. and modern sector pharmas, namely
Ranbaxy, Lupin, Allembic, etc. are standardizing their herbal
formulations by chromatography techniques like TLC/HPLC finger
printing, etc.

There are about 7000 firms in the small-scale sector manufacturing
traditional medicines with or without standardization.

However, none of the pharma has standardized herbal medicines using
active compounds as markers linked with confirmation of bioactivity
of herbal drugs in experimental animal models.
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Role of WHO in Herbal Medicine
Two decades ago, WHO referred to traditional health systems (including
herbal medicine) as holistic that of viewing man in his totality within
a wide ecological spectrum, and of emphasizing the view that illness or
disease is brought about by an imbalance or disequilibrium of man in his
total ecological system and not only by the causative agent and pathogenic
evolution.
As a consequence, in 1991 WHO developed guidelines for the
assessment of herbal medicine. The salient features are:
(i) Quality assessment: Crude plant material; Plant preparation;
Finished product.
(ii) Stability: Shelf life.
(iii) Safety assessment: Documentation of safety based on experience
or/and; Toxicology studies.
(iv) Assessment of efficacy: Documented evidence of traditional use
or/and; Activity determination (animals, human).
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US FDA on Herbal Medicines
In the USA, the FD&C Act characterizes a product primarily on the basis
of its intended use.
Botanical products may be intended for use as a food (dietary supplement),
a drug, a medical device or a cosmetic.
For herbal products classified as drugs, the FDA regulates them under the
authority of the FD&C Act and its amendments.
Under current regulations, for botanical drug products with no marketing
history in the USA, if the available safety data or the proposed intended use
does not warrant the inclusion of drug product in the category of OTC
drugs, an NDA is to be submitted to obtain FDA approval to market the
product.

If existing information on the safety and efficacy of a botanical drug
product is insufficient to support an NDA, new clinical studies will be
needed to demonstrate safety and effectiveness.
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1. claims a benefit related to a classical nutrient deficiency disease;
2. describes how the product is intended to affect the structure or
function of the human body;
3. characterizes the documented mechanism by which the product
acts to maintain such structure or function; or
4. describes general well-being derived from consumption of the
product
Herbal Products claimed as dietary supplements, under the Dietary
Supplement Health and Education Act (DSHEA), may be lawfully
marketed using a statement that
Generally, such products need not be registered with FDA for producing
or selling, but the manufacturer must make sure that label information
on the product is truthful and not misleading.
Hence, most botanical products in the USA are marketed as
dietary supplements (Nutraceuticals)
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Challenges concerning Herbal Medicines
Several problems that are not applicable to synthetic drugs influence the
quality of herbal drugs
o Herbal drugs are usually mixtures of many constituents.
o The active principle(s) is (are), in most cases unknown.
o Selective analytical methods or reference compounds may not be
available commercially.
o The Plant materials are chemically and naturally variable.
o The source and quality of the raw material are variable.
o The methods of harvesting, drying, storage, transportation, and
processing have an effect.
o When the active principles are unknown, marker substance(s) should be
established for analytical purposes and standardization.
The successful production of a quality herbal product and
reproducibility of that quality is a tough task.
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Standardisation of Herbal Medicines
Standardisation involves Adjusting the herbal drug preparation to a
defined content of a constituent or a group of substances with known
therapeutic activity respectively by adding excipients or by mixing herbal
drug extracts.

This is important as there are many variables that can influence the
content of the component of interest in plants.

This involves
1. Pharmacognostical
2. Physico-chemical
3. Phytochemical and
4. Residual analysis
Residual Analysis determines the safety of the herbal product.
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Clinical Approach in herbal medicines
Clinical studies on the medicinal plants is unorganized and about 0.75
per cent of these drugs, based on reports published in national journal,
have been screened in clinical trial for a particular disease.

If international status of the clinical reports is considered, then this
figure will be less than 0.1 per cent.

Experiments have been conducted mainly on popular Ayurvedic drugs
without involvement of biostaticians to substantiate the traditional uses
of plant drugs.
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For a Better Herbal
Future,
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It is also necessary to develop genetically superior planting
material for assured uniformity and desired quality and resort
to organized cultivation to ensure the supply of raw material
at growers end.
Major variations are observed with changes in cultivation
techniques, harvesting methods, use of fertilizers and pestisides
and waste disposal.
Uniformity is a major problem with Herbal Products.
Hence research and development work has to be done to formulate
Good Agricultural Practices (GAP)
Post harvest storage and process technologies need to be developed
to produce the value added finished products that may be directly
utilized by the industry.
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Hence, there is an urgent need to understand the nature
of interactionsamong these types of drugs in vivo.
Often patients use traditional and conventional
medicine simultaneously.
Also, many herbal products are Multi-Herbal
Formulations.
Lack of information in this respect have raised serious concern
among the medical scientists about the safety of the patients,
which needs to be addressed immediately (Chattopadhyay, 1997).
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Some of them contain mercury, lead, arsenic (Kew et al.,
1993) and corticosteroids (De Smet, 1997) and poisonous
organic substances in harmful amount. Hepatic failure
and even death following ingestion of herbal medicine have
been reported (Chattopadhyay, 1996).
Most herbal products on the market today have not been subjected
to drug approval process to demonstrate their safety and
effectiveness.
This stresses the need for standardisation of Plant
material, especially for Residual Analysis, using Hyphenated
Modern Analytical Techniques.
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To gain public trust and more importantly the trust of
Conventional Medical Practitioners that brings herbal
medicine to mainstream of health care system, the
researchers, the manufacturers and the regulatory
agencies must apply rigorous scientific methodologies
and clinical trails to ensure the quality, safety and
lot-to-lot consistency of the traditional herbal products.
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The R & D thrust in the pharmaceutical sector must be focused on
development of new innovative / indigenous plant- based drugs
through investigation of leads from the traditional system of medicine.

It is necessary to that traditional and modern medicine
techniques must be coupled in order to bring out high
quality herbal products like Herbal NDDS
for targeted drug delivery with rapid onset of action and
good bioavailability.
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Nature always stands as a golden mark to exemplify the outstanding
phenomena of symbiosis.
In the western world, as the people are becoming aware of the
potency and side effect of synthetic drugs, there is an increasing
interest in the natural product remedies with a basic approach
towards the nature.
There is a great scope for mainstream R&D in all fields of Herbal
Medicine from plant bio-technology to development of newer
formulations to promote good bioavailability.
India has a moral responsibility towards the betterment of
herbal medicine owing to its wealth of natural resources
and vast knowledge in the aspects of traditional medicine.
The Final Say
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References
Herbal Medicine: Current Status and the Future (Asian Pacific J
Cancer Prev, 4, ISSN: 281-288)
Current Status of Herbal Drugs in the Development of Newer
Therapeutics Agents (International Journal of Pharmaceutical
and Chemical Sciences, ISSN: 2277-5005; Vol. 2 (3) Jul-Sep 2013)
PRESENT STATUS OF HERBAL MEDICINES IN INDIA (Journal of
Herbal Medicine and Toxicology 3 (2) 1-7 (2009); ISSN : 0973-
4643)
WHO guidelines on safety monitoring of herbal medicines
National policy on traditional Medicine and regulation of
herbal medicines - Report of a WHO global survey (ISBN 92 4
159323 7)
google.com
Wikipedia.org
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THANK YOU
FOR
YOUR ATTENTION!

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