صفحه 1:
صفحه 2:
Raw material: Sustainable
availability and concern
regarding medicinal plants on
negative list
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Orevor Ceverd
هه" ره Por kerbd wad Biierk Products
لس ,سلجم ۱
Cowkwe oa 19 8 ۷ Dov, 9 دصقم هاه"
ببو عبسلهت() للم
صفحه 3:
AMITY Traditional Medicine
۲۲۸(
All healthcare practices and
treatment of diseases practiced
by traditional communities or
local people in most of the third
world nations are termed as
Traditional Medicine.
In fact all medicare
practices of whole humankind
before the on set of modern
medicine in 19% Century were
صفحه 4:
TM:
World Health Organization (WHO) defined
TM as the sum total of the knowledge, skills
and practices based on the theories, beliefs
and experiences of indigenous cultures
whether explicable or not used in the
maintenance of health and in the prevention,
diagnosis, improvement or treatment of
physical and mental illness. The term
‘complementary medicine’, ‘alternate
medicine’, and ‘non-conventional medicine’
etc. are used interchangeably with
‘traditional medicine’ in some countries.
The raw materials for TM is mainly
medicinal plants.
صفحه 5:
Sure es
oe Fact file on Medicinal
Plants
° Medicinal lants are important
components of Biodiveristy-a product of
3500 million years of evolution life on
Earth.
30-100 Million species of life on Earth
today
— 300,000 higher plants - out of which
216,000 are in TROPICS
— Over 75,000 higher plants are used by
different cultures for medicinal &
aromatic purpose
— Over 15,000 higher plants species are
used in Asia
* About 7,000 in China & About 8,000 India
صفحه 6:
Flowering plants used in
Traditional Systems of Medicine
in India
5 Medicine
30 spp.
[1 Ayurveda 900 spp.
Amchi 300 spp.
Unani 700 spp.
صفحه 7:
Some features of
modern health care
Modern health care policies largely
market driven by the pharmaceutical
industry diverting attention from
health preservation to illness cure
Prevention and_ eradication of
diseases undermines the economic
basis of this industry
No satisfactory drugs available for
most of the degenerative disorders
characteristic of graying population
and for re-emerging resistant
infections
AMITY
We nurture
talent
صفحه 8:
AMITY
We nurture
the Modern Drugs / Herbal
Drugs
® Modern drugs normally single molecules,
rigorously tested, structures optimized,
toxicologically cleared, Mechanism
generally known and clinical trials done.
Herbals have many molecules, safety and
efficacy based on_ experiences’ of
practitioners.
¢ Many modern drugs known to have severe
side reactions (4'* - 6 largest cause of
death in US)
Herbals generally considered benign.
Mechanism of action not known
© More than 40 % modern drugs are plant based.
صفحه 9:
AMITY AQGVantages OF merpal
Drugs
> Modern drugs can produce serious side
effects
¢ Iatrogenic diseases fourth leading cause of
death in USA and other developed nations
(AMA, April 1998).
* Side effects of drugs kill more Americans
annually than the world war II and Vietnam
war combined (N. Y. Times 28.02.2003)
¢ Around 2600 persons died in the Twin
Tower tragedy on 11" September 2001
causing global repercussions. غ1 is,
however, not recognized that about the
same number die in USA from side effects
of prescription drugs every 10 days (JAMA,
April 1998).
صفحه 10:
AMITY strength of Ayurveda:
Challenging diseases for
which herbal drugs can
" For stand adevanpanswer
- Degenerative, metabolic and immune
based diseases having multiple causes like
cancer, diabetes, arthritis, peptic ulcer,
cardiovascular disorders, osteoporosis,
Alzheimer and other CNS disorders.
-parasite based diseases like malaria,
aria.
= Adjuvants: primarily to reduce side effects
=" Mop-up therapy: immuno-stimulants for
cancer TB etc.
= Prophylactics for diabetes, cancer
" Detoxifiers based on Ayurveda/Sidda/Unani
صفحه 11:
Weakness: Lack of Quality
assurance of raw
materials/medicinal plants
The therapeutic quality/effect of
medicinal plants are due to the presence
of the biologically active chemicals
which are mostly secondary metabolities
such as alkaloids, glycosides, saponins,
coumarins, flavonoids and terpenes, etc.
75% to 80% of the medicinal plants
required in Traditional Medicines (TM)
is collected from wild. Sustained supply
of quality raw materials is therefore
difficult.
صفحه 12:
Weakness: Lack of
Quality assurance
= 35 to 40% of the Medicinal plants
used in TM are cross-pollinated
species and hence there exists
vast intraspecific genetic
variability with respect to the
morphological and chemical
constituents.
" Heritability of these compounds
are controlled by a variety of
factors-genetic and macro and
micro environment, season and
talent
صفحه 13:
We nurture
Weakness:
* Lack of written documentary evidence
on clinical efficacy.
٠ TM- more particularly Ayurveda was/is
essentially a highly customized/
individualized medicine. Transformation
into a generalized and commercial
system has adversely affected the system
٠ Lack of consistency in quality in batch to
batch production of products.
٠ Lack of a well defined and well
orchestrated SOP.
صفحه 14:
“MY Quality assurance of raw
materials
"Genetic variants (at ploidy level or
ene level) leading to the variability
in the chemical composition in the
population.
"Geographical and edaphic factors-
altitude, soil composition, microbial
load/association, climate,
temperature, season etc can cause
variation.
" Association with plants, animals and
insects.
صفحه 15:
اهم تلع 5ه ععمه تدده لااناهیام 2۳۳۲۲
plants
"Eg. Seasonal variations in the
alkaloid composition in the leaves
of Adhatoda vasica has_ been
recorded. It is lowest in February
and March and highest in the
months of August, September and
October. Similarly variation of
alkaloid contents based on the
age of the plant is reported in
Holarrhena antidysenterica
صفحه 16:
Herbal Medicine د
Regulation in
European Union
TM like Ayurveda gained popularity in
Europe as a willness system.
Ayurveda and other TM drugs were
marketed as food supplements,
cosmetics and health promoters.
After the formation of European
Union, the member countries decided
to have their herbal industries and
products under identical medicine
controls by the end of 1992.
صفحه 17:
Herbal Medicine
Regulation
UK was the first to introduce a
Medicine Law in 1968 which made it
mandatory to license all Herbal
(Medicine) manufactured. Pure herbal
medicine prepared by herbalist for
treating his patients are exempted
under sec. 12 of the Act licensing herbal
medicine demanded documentary proof
of efficacy and safety data.
We nurture
talent
صفحه 18:
AMITY
We nurture
“ Herbal Medicine
The Euregulatien directed that any
product legally sold in one country of the Union
must be freely sold in all other countries-with a
provision “as long as the product was safe and
did not harm consumers. EC Directive on
Traditional Herbal medicine products
(2001/83/EC and amendment 2004/27/EC).
The Directive came into force from 1st Nov
2005 with a transitional period upto 2011. It
introduced a fast track Traditional Use
Registration (TUR) which need not supply any
costly safety studies that need to provide
documentary evidence of its traditional use.
صفحه 19:
Traditional Use
Registration (TUR)
Under TUR, TM can be sold without
the intervention of practitioner. For
registering such products has to
produce data on quality, traditional
use history for a total of 30 yrs of
which 15 years should be within EU
countries. Registration of such
product, however, could cost as much
as E 7500 to 100,000 per product.
صفحه 20:
We nurture
talent
Positive list of herbal
substance
A committee for Herbal Medicinal
products is established by the Directive, to
prepare a positive list of herbal substances
with therapeutic indicators, specified
strength, route of administration and
relevant safety information. The applicant
can get the exemption from licensing
without any traditional use data or safety
data of the concerned herbal substance is
in the list but just providing the quality
data in the form of monographs.
صفحه 21:
AMITY
a Positive & Negative
The Geri St commission E came out with
monographs for Therapeutic Guide to
Herbal medicine which covered extensive
published literature as chemistry,
pharmacology, clinical and toxicology of
herbal drugs and preparing a positive as
well as negative list of herbal drugs and
medicinal plants. The German Commission
so far made a list of 254 positive
monographs and 126 unapproved
(negative) monograph. 45 herbs were
negatively evaluated based on document
risk.
صفحه 22:
Negative List:
This include Indian plants like:
Basil, Celery, Chamomile, Cocoa,
Colycynth, Ergot, Lemon grass, Liver
wort, Marjoram, Nutmeg, Periwinkle,
Oleander, Nuxuomica, Passely seeds,
Papain seeds, Rhododendron, saffron,
Sarasaparilla roots, walnut null. The
commission also developed a neetral
list which are suspected danger list.
Basil is Ocimum basilicum having
estragole with mutagenic effect
We nuts
talent
صفحه 23:
Neutral list
57 unapproved monographs due lack
of scientific documentation of the use
claimed by industry is kept under
neutral list with the condition that if
safety and efficacy data is provided it
can be included in the positive list.
This include:
Calendula, Chestnut leaf, Pimpenella,
Papaya leaf, Corsuflower, Re
sandalwood, Spinach leaf, Figs,
Echinacea angustifolia, Ginkgo biloba
6
ها
talent
صفحه 24:
۸۳۲ Sweden’s negative list of
medicinal plants for
health food
June 2005 Sweden came out with another
negative list of medicinal plants based on
toxicological evaluation of medicinal plants
and recommended not to use them in health
food, or nutraceuticals or in food
supplements. This include plants of Indian
origin such as
Acorus colamus, Aristolochia spp, Cinnamon
flowers, Balladonna, Berberis, Cannabis
sativa, Taxus baccata, coleus forskohiii,
Ephedra spp Gingo biloba, Ruta graveolens,
trychnos seeds, Veronica Solanum nigrum
66
صفحه 25:
““* Reason for decline of
quality in TM like
Ayurvedic medicine
TM like Ayurveda was/is essentially a
personalized/customized system of
diagnosis and treatment. Collection
of raw materials, preprocessing were
done as per strict guideline which
was based on experiential wisdom.
Transformation into generalized and
commercial system Ayurveda
suffered greatly in quality assurance.
صفحه 26:
Traditional Medicine: ف
Threats
Poor positioning on a global level
Ignored by global scientific community
Very little work on scientific validations
Lack of well defined and well
orchestrated SOP
Very little publication in peer reviewed
journals
Deliberative negative propaganda
صفحه 27:
Minimum requirements for
TM for global acceptance
Demonstrated Safety
Mapped Efficacy (Pharmacological
credible ene coes 9 3
Sustained availability of quality raw
materials
Consistency in batch to batch quality
For polyherbals, contribution of each
herb to be roved along with
synergism. It should be synergistic
rather than additive
Avoidance of endangered species
Easy availability and accessibility of
medicinal plant.
talent
صفحه 28:
Need for:
Domestication, genetic enhancement
& cultivation of important wild
medicinal plants with stable heritable
characters of therapeutic importance.
Development of package of practices
& post harvest handling of medicinal
plants/ raw material.
Scientific validation of the
therapeutic claims
Safety
Customer satisfaction and confidence
صفحه 29:
Need for: Standardization of
raw materials
Correct taxonomic identification of
medicinal plant.
Study on the medicinal part: root, stem,
bark, leaves, flowers, fruits, nuts, gum,
resins, etc.
Collection details: location, stage &
development/growth of the plants, time,
pre-processing if any, storage etc.
Organoleptic examination of raw drug-
Evaluation by means of sensory organs:
touch, odour taste
Microscopic & molecular examination
Chemical composition (TLC, GLC, HPLC
and DNA fingerprinting of the plant.
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FI re ال et aE ea
AMITY
We nurture
talent
صفحه 30:
roa Need for: Good
~ practices/Techniques in
Herbal products
* Good survey of literature (Ancient &
Modern)
٠ Develop and Observe Norms of:
" Good Agricultural Practices (GAP)
" Good Collection/Harvesting and Post
Harvest Handling Practices (GCP/GHP
& GPHP)
" Good Laboratory Practices (GLP)
* Good Clinical Practices &
Pharmacovigilence (GCP & PV)
« Good Manufacturing Practices (GMP)
=" Good Marketing Techniques (GMT)
صفحه 31:
1111 You