Herbal drugs/ Pharmaceuticals

Problems and Prognosis

Dr. P. Pushpangadan
Director, National Botanical Research Institute
Lucknow, India

5 trillion $

2020

62 billion $

2005

Growing popularity
Business standard, 2005

ccessible
ffordable
ssured safety

About 70% Indian population (60-70

crore) depends on alternative system
of medicine.

WHO

Herbal drugs are

cheaper than
generic drugs !!??

Herbal drugs
have been
used in India
for more than
4000 years.

Allopathy or Modern Medicine

Glamorized discipline
Pursued by most (influenced and so called

Literate) in India and, in western countries

Backed by technological advances investigations
Based on sound scientific reasoning
experimental evidence; not anecdotal
Thus, Modern Medicine is an evidencebased, techno-savvy science that seems to
provide ultimate care to sick patients

Allopathy or Modern Medicine

But????
The treatment is often symptomatic, costly,

out of reach of most in developing countries

Except for infective pathologies, we do not
have much to offer except palliation
Treatment of Chronic Lifestyle Disorders like
neurodegenerative disorders is often very
disappointing and limited by adverse events
It treats the Disease (symptomatic) and not
the patient as a whole (Holistic approach)

Therapeutic Objective
The ultimate goal of every physician is to

CURE the disease.

Has Allopathy achieved this goal for all
ailments? No;
Except for infective pathologies, we do not
achieve CURE
Most often the treatment is Symptomatic and
Palliative.

Effective & Safe Medicine

Drug Discovery problems

It is notoriously inefficient
One in a hundred thousand or more compounds will

enter the market as a drug

Pharma majors have NO interest in higher plants
extracts for screening for biological activity
In NAPRALERT ethnomedical reports for 14,300
species (5.2% of all plant species) are there;

But 58% of these species have never been examined

biologically or chemically
Of these 74% are used in a manner which parallels
their ethnomedical use

Golden triangle
Traditional medicine

Modern medicine

Modern science

Thus making cheaper affordable and safe medicine

Mashelkar 2005

Examples of some important plant derived drugs

Compound

Plant Species

Acetyl digoxin

Digitalis lanata

Ajmalicine

Catharanthus roseus, Rauwolfia sp.

Ajmmaline

Rauvolfia serpentina

Andrographolide

Andrographis paniculata

Artemissine

Artemisia annua

Asiaticoside

Centella asiatica

Berberine

Berberis spp.

Caffeine

Camellia sinensis

Caffeine

Camellia sinensis

Cocaine

Erythroxylum cocoa

Codeine

Papaver spp.

Codiene

Papaver somniferum

Colchicine

Colchicum autumnale, Gloriosa superba

Curcumin

Curcuma longa

Digitoxin, Digoxin, Digitoxigenin

Digitalis spp.

Emetine

Cephaelis ipecacuanha

Ephedrine

Ephedra gerardiana

Ergometrine, Ergotamine, Ergotoxin

Claviceps purpurea on Rye plants

Glycyrrhizin, Glycyrrhizinic acid

Glycyrrhiza glabra

Hesperidin

Citrus spp. Mentha spp.

Contd..

Examples of some important plant derived drugs (Contd..)

Hyoscine

Duboisia spp.

Hyoscyamine

Datura spp, Hyscyamus spp.

L-Dopa

Mucuna pruriens

Menthol

Mentha spp.

Morphine

Papaver spp.

Papain

Carica papaya

Podophyliotoxin

Podophyllum emodi

Quinine, Quinidine

Cinchona spp.

Reserpine & Deserpidine

Rauvolfia serpentina,

Rutin

Eucalyptus spp, Fagopyrum spp, Sophora japonica

Scopolamin

Datura sp.

Sennosides A&B

Cassia angustifolia, C. acutifolia

Silymarin

Silybum marianum

Strychnine

Strychnos nux-vomica

Taxol

Taxus baccata

Thymol
Vinblastine, Vincristine
Xanthotoxin
Chemical Intermediates
Citral
Diosgenin
Phytosterols (Stigmasterol & Sitosterol)

Thymus vulgaris
Catharanthus roseus
Ammi majus, Heracleum candicans

Solasodine
Hypercin, Hyperforin

Solanum
Hypericum perforatum

Lemon grass
Dioscorea spp. Costus spp.
Soya & Calabar Beans

Traditional medicine
Historical background
Earliest recorded use of a medicinal plant has

been mentioned in Rigveda

one mentioned in the modern texts is that of the
herb called Ma huang a species of Ephedra
used medicinally in China for over 5000 years
Cinchona was used by local south American
tribes long before before the isolation of quinine
for treating malaria
Source of aspirin (Salix officinalis) was used as
pain killer for long time before being identified

Traditional medicines
Middle of 19th century, 80% of all medicines

were herbal
Even today 25% of drugs are derived from
plant source
Most of these drugs came from traditional
lead, folk knowledge etc.
Some of these still could not substituted
despite the enormous advancement in
synthetic chemistry eg. Reserpine, taxol,
vincristine etc.

Revival of herbal medicine

widespread belief that green medicine is healthier

than synthetic products

leading to rapid spurt of demand for health products
like herbal tea, ginseng and such products of
traditional medicine
So rapid sale of herbal products are staggering 100
billion dollars a year.
After India and China, even the western world has
started working on herbals
NIH has set up CAM center and working on St.
Johns wort and Gingko biloba

Drug development based on traditional leads

Survey of traditional remedies
Choice of plant

Traditional formulation

Related
species

Identification,
authentication
Collection

Extraction

Clinical
trial

Biological
screening
Effective

Active

1. Analytical
standard
2. Safety
3. Modernise
Technology
4. New Dosage
Forms
Pharmacokinetics/Pharmacodynamics
Pilot Plant Production

Bioassay Linked Fractionation

Active Compound(s) Characterisation
Pure Compound, Standardised Extracts
1. Pharmacology
2. Toxicity
3. Clinical Pharmacology

Clinical Trials
Commercial
Production
Marketing

Bio-availability

Registration

Reverse pharmacology
What is required is Scientific evidence
Answer lies in providing scientific validation

for efficacy and safety

Screening based on ethnomedical and
ethnobotanical lead as chances of hitting the
target is more

System biology

The health triangle. The survival potential of all living systems, H, is expressed in the
health triangle, structured with lifes common denominator: Intelligence, Energy and

Synergy
Most of the effective phytomedicine in market are

as whole extracts of plants

Practitioners believe that synergistic interactions
between the components of individual or mixture
of herbs are a vital part of therapeutic efficacy
Mechanism of action of many phytomedicine is
still unknown and there are several instance
where total extract shows better activity than an
equalent dose of isolated compound
chemical and pharmacological evidence to
demonstrate conclusively the concept of
synergism

Multi-target approach
Combinations of herbs are normal and are

based on empirical observation and reasoning

based on a particular patient
these herbal combinations may not be
targeted to a particular organ (multi-targeted),
cell, tissue or any biochemical system, making
this synergy even more difficult to identify
possibility of drug interactions and the
adverse reactions arising out of these have to
be checked before coming out with the drug

Multiple Targets Need A Combo

Plant A
Plant B
Plant C
Plant D
Plant E
Plant F
Plant G
Plant H

Pain,
Cartilage
Inflammation
Oxidative stress
Osteoporosis
Anabolic
CNS
Immunomodulator
Antistress
Bioavailability
Lubricant

Activity Matrix: Systems-Biology Approach

Pharmacovigilance
Any thing herbal is safe!!?????
Adverse drug reactions (ADR)
Drug-drug interactions
Herb-Drug interactions
Toxicity of the isolated ingredients
Traditional process (Shodhana)

Traditional Medicine: Threats

Poor positioning on a global level
Ignored by the global scientific community
Very little scientific research validations
Very little publications in peer-reviewed

science Journals
Deliberate negative propagandas

Traditional medicine: Future

Innovative, Effective and

Aggressive use of Emerging
Technologies without
Compromising the Basic
Principles will be the main key
towards the bright future

Final Product

Global Market

Traditional Approach

Selection of potential plants

Extraction and fractionation

IPR

Drug Discovery

Activity guided isolation of active copounds

Clinical studies

Standardization of the formulation(s)

Toxicity stuides

Formulation and Doasge studies

Pharmacological studies