The Current and Future Scenario of Herbal Medicine - an Overview

8/12/2019 The Current and Future Scenario of Herbal Medicine - an Overview

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Herbal Vs Conventional Systems of Medicine

Although superficially similar, herbal medicine & conventional

pharmacotherapy have three important di fferences

Use of Whole Plants - Herbalists generally use un-purified plant extracts

containing several different constituents. It is claimed that these can work

together synergisticallyand that the overall toxicity is reducedin this

way (buffering).

Herb Combining -Often several different herbs are used together.

Practitioners say that the principles of synergy and bufferingapply 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.

www.kvsrsiddharthapharma.edu.in


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The pharmacological treatment of disease with the use of herbs havebeen the basis for medical systems since the dawn of human

civilization.

Methods of traditional healing throughout the world commonly usedherbs 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)orAyurvedic Medicineis 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 knownAyurvedic textsare

The SuruthaSahit (majorly onsurgery) &

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 spir i t in disease management.



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Traditional Chinese Medicineis a broad range of medicine

practices that were developed in China from ancient times, andinclude various forms of herbal medicine, acupuncture, massage,

exercise, and dietary therapy.

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

Traditional Chinese medicine is stil l in common usein China.

About 5000 traditional remedies are still availablein China and

they account for approximately one fifthof 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 weredivine 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 Romewas much like in ancient Greek Ancient

Roman medicine included a number of special izationssuch as internal

medicine, ophthalmology and urology.Public healthwas encouragedby 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 scienti f ic 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 scienti f ic medicine were set.



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The Current Statusof

Herbal Medicine


Herbal Medicines have stood the test of time for their safety, efficacyand lesser side effects.


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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 contr ibuted 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 andvincristine).



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In spite of the fact that a vast majority of the drugs inpharmaceuticals are derived from Natural Sources (mostly

Plants),

The demand for

herbal products as suchis increasing progressively



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Herbal Products are

Finished labelled products that contain active ingredientssuch as

Aerial or Underground parts of a plantor other plant material orcombinations 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 Supplimentscontaining Herbal Products, also calledNutraceuticalsavailable in modern dosage forms.

Herbal Medicinesconsisting of either Crude, Processed or Semi

ProcessedMedicinal Plants.



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Herbal Medicine is on the Raise

The US herbal medicine marketis about $4 - $8 billion now. The herbal medicine market in the countries of theEuropean

Unionis over $ 20 billion now.

The market in Germanyis 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 Germanyand France, herbal extracts are sold as

prescription drugs and are covered by national health insurance.

Global Herbal Supplement Market To Reach $107 Bil l ion By 2017

says a report from Global Industry Analysts



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Reasons adul ts in the US use Herbal M edicine



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4 of the 10 most widely selling herbal medicinesin developed countries,

namely preparation of Ocimum sanctum,Allium sativum,Aloe

barbadensis and Panaxspecies are available and exported from India.

Panax ( all Healin greek)

Allium sativumAloe barbadensis

Ocimum sanctumwww.kvsrsiddharthapharma.edu.in


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Herbal medicine scenar io in I ndia (contd.,)

Indiais one of the 12 mega biodiversity centres having

over 45,000 plant species.Its diversity is unmatcheddue to the presence

of 16 different agro-climatic zones, 10 vegetative zonesand 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 madetowards the development of

agro-technologiesfor 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 standardizingtheir herbal

formulations by chromatography techniques like TLC/HPLC finger

printing, etc.

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

However, none of the pharma has standardized herbal medicines using

active compounds as markerslinked with confirmation of bioactivityof herbal drugs in experimental animal models.



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Role of WHO in Herbal Medicine

Two decades ago, WHOreferred 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 ordisease 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 theassessment 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 experienceor/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 character izes a product primari ly on the basis

of its intended use.

Botanical products may be intended for use as a food (dietary supplement),a drug, a medical deviceor 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 war rantthe inclusion of drug product in the category of OTC

drugs, an NDA is to be submitted to obtain FDA approvalto market the

product.

If existing information on the safety and eff icacy of a botanical drug

product is insuf f icientto support an NDA, new clini cal studieswill 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; or4. 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 registeredwith FDAfor 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 mixturesof many constituents.o The active principle(s)is (are), in most cases unknown.

o Selective analytical methodsor reference compounds may not be

availablecommercially.

o ThePlant materialsare chemically and naturally variable.

o The source and quality of the raw material are variable.

o The methodsof harvesting, drying, storage, transportation, and

processing have an effect.

o When the active principles are unknown, marker substance(s) should be

establishedfor analytical purposes and standardization.

The successful production of a quali ty herbal product and

reproducibil i ty of that qual i ty is a tough task.



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Standardisation of Herbal M edicines

Standardisation involvesAdjusting the herbal drug preparation to a

defined content of a constituentor a group of substances with known

therapeutic activity respectively by adding excipients or by mixing herbaldrug 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.Phytochemicaland4.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 statusof the clinical reports is considered, then this

figure will be less than 0.1 per cent.

Experiments have been conducted mainly on popular Ayurvedic drugswithout involvement of biostaticians to substantiate the traditional uses

of plant drugs.



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For a Better HerbalFuture,



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It is also necessary to develop genetically superior planting

materialfor 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 pestisidesand 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 thenatureof 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 containmercury, lead, arsenic(Kew et al.,

1993) and corticosteroids(De Smet, 1997) and poisonous

organic substances in harmful amount. Hepatic failureand 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 standardisationof Plantmaterial, especially for Residual Analysis, using Hyphenated

Modern Analytical Techniques.



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To gain public trust and more importantly the trust ofConventional Medical Practi tioners that brings herbal

medicine to mainstreamof health care system, the

researchers, the manufacturers and the regulatory

agencies must apply rigorous scientific methodologies

and clinical trai lsto ensure the quality, safety andlot-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 NDDSfor 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 agreat scope for mainstream R&D in all fields of Herbal

Medicinefrom plant bio-technology to development of newer

formulations to promote good bioavailability.

India has a moral responsibility towards the betterment ofherbal medicine owing to its wealth of natural resources

and vast knowledge in the aspects of traditional medicine.

The Final Say


R f


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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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YOUR ATTENTION!

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The Current and Future Scenario of Herbal Medicine - an Overview