Quality control & standardization of herbal drugs - Prof. Palpu ...

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Biodiversity Wealth and Opportunities for
Asia Pacific Countries in Biotechnology &
Herbal Technology

P. Pushpangadan

National Botanical Research Institute

(Council of Scientific &Industrial Research),

Rana Pratap Marg, Lucknow
-
226001

(September 2003)

WORLD TRADE AND ECONOMIES:
THE PARADIGM SHIFT



Resource



based

economies’

to

‘Knowledge


based

economies’



21

st

Century

will

be

the

Century

of

Knowledge”
……



A

nation’s

ability

to

convert

knowledge

in

to

wealth

and

social

good

through

the

process

of

innovation

will

determine

its

future”

(

R

A

Mashelkar,

2001
)

21
st

Century

21
st

century is the century of Biology powered and
propelled by scientific knowledge and technological
expertise

Three technologies namely



Biotechnology



Herbal technology



Information technology (Bioinformatics)

are going to be the most powerful elements
that are crucial for prosperity and welfare
for the people of nations.

Herbal technology

All

technologies

for

the

manufacture

of

value

added

plant

products

can

be

called

as

herbal

technology



Herbal

drugs

and

pharmaceuticals,



Nutraceuticals,



Functional

foods,

designer

foods

or

health

foods


and

health

drinks



Cosmaceuticals



Biocontrol

agents



Biopesticides

WORLD TRADE AND ECONOMIES:
THE PARADIGM SHIFT



Resource



based

economies’

to

‘Knowledge


based

economies’



21

st

Century

will

be

the

Century

of

Knowledge”
……



A

nation’s

ability

to

convert

knowledge

in

to

wealth

and

social

good

through

the

process

of

innovation

will

determine

its

future”

(

R

A

Mashelkar,

2001
)

Genesis of the Global Concern on
Biodiversity Conservation


UNEP

constituted

an

ad
-
hoc

Working

Group

of

Technological

and

Legal

experts

to

prepare

an

international

legal

instrument

for

conservation

and

sustainable

use

of

Biodiversity

which

resulted

in

‘CONVENTION

ON

BIOLOGICAL

DIVERSITY’

(CBD)
.



171

countries

signed

CBD

in

June

1992

during

the

Earth

summit

at

Rio

de

Janeiro
.



CBD

came

-

into

force

as

an

International

Law

on

29
th

Dec
.

1993
.



186

countries

are

now

parties

to

CBD

(as

on

Feb
.

2003
)

IUCN, UNEP & WWF 1980 came out with the
first Global Strategy for Conservation.

This Strategy defined conservation as:

“Management of human use of biodiversity so that
it may yield the greatest sustainable benefit to
present generation while maintaining its potential
to meet the needs and aspirations of future
generation”

This definition involves two complementary
components ‘Conservation’ and ‘sustainability’

Conservation of Biodiversity

Strategies & Priorities

Biodiversity & TK: Capital Assets
of Asia
-
Pacific Countries


Biodiversity

and

TK

are

two

invaluable

capital

assets

of

South

countries

for
:



Building up IPR
-

covered bio
-
industrial
enterprises


Herbal Drugs


Pharmaceuticals


Natural product development sectors



Generating economic wealth and
improving quality of life and well
-

being of
people



Contd…….


Building up S&T capability in advanced
technologies of bioprospecting


Human resource development in
Biotechnology, Bioinformatics and
Bioprospecting


Empowering local and indigenous
communities for conservation,
sustainable use and building up location

specific biodiversity enterprises through
S&T intervention

Biodiversity & TK: Capital Assets
of Asia
-
Pacific Countries

(Contd.)

Biodiversity & TK: Bridging the
North
-
South Gap

Asia
-
Pacific countries SHOULD:


Develop capability in biotechnology,
bioinformatics and bioprospecting through
national, regional and global
‘biopartnership’ programmes


Address and resolve the issues of access
to and transfer of genetic resources and
technologies between North
-

South
countries

Contd……..



Prevent bio
-
piracy and
misappropriation of genetic
resources and TK


Develop an international system for
protection of TK


Develop effective mechanisms for
fair and equitable benefit sharing
and technology transfers

Biodiversity & TK: Bridging the
North
-

South Gap

Asia
-
Pacific Countries should:


Convention of Biodiversity (CBD)

Relevant Provisions of CBD


Article

3

recognizes

the

sovereign

rights

of

States

over

their

biological

resources
.




Article

15

states

that

when

access

to

genetic

resources

is

granted,

it

shall

be

on

mutually

agreed

upon

terms

and

subject

to

Prior

Informed

Consent
.




Incentives

to

biodiversity
-
rich

countries

to

conserve

and

sustainably

use

their

genetic

resources,

including

joint

research,

access

to

&

transfer

of

technology

(Articles

15
,
16
)
.



Relevant Provisions of CBD

(Contd...)



Article

16
.
2

addresses

issues

surrounding

the

access

to

and

transfer

of

technology,

governed

by

patents
.



Article

16
.
5

anticipates

the

difference

in

objectives

between

IPR

regimes

and

the

CBD

and

seeks

to

ensure

that

IPRs

don't

run

counter

to

the

CBD
.



Article

8
(j)

underlines

the

need

to

protect

TK

and

points

to

the

potential

benefits

to

be

realized

from

such

knowledge

through

involvement

of

its

holders

and

equitable

benefit
-
sharing
.

Relevant Provisions of TRIPs on
Biological Resources


Under

Article

27
,

virtually

all

inventions

are

to

be

patented

if

they

are

new,

involve

an

innovative/inventive

step

and

are

capable

of

industrial

application
.



Exceptions

to

patentability

include

plants,

animals

(

other

than

microbes)

and

biological

processes

for

the

production

of

the

above
.

However

plant

varieties

must

be

protected

either

by

sui

generis

or

by

patenting

(
27
.
3
(b))
.


Article

30

confers

limited

exceptions

to

the

rights

conferred

on

patent

holders,

taking

into

account

the

legitimate

interests

of

third

parties
.



Article

29

imposes

two

conditions

on

patent

applicants
;

that

they

disclose

the

invention

clearly

and

completely

enough

for

a

person

skilled

in

the

art

to

reproduce

it

and

it

'may'

require

an

applicant

to

provide

information

concerning

the

applicant's

corresponding

foreign

applications

and

grants
.



Relevant Provisions of TRIPs on
Biological Resources

(Contd….)

TRIPS
-
CBD Relationship



Absence

of

explicit

compatibility,

Difference

of

approach

and

priority

given

to

issues

which

are

ultimately

related
.

This

has

led

to

violation

of

the

CBD

(Articles

8
,
15

&
16
)
.



TRIPs

ignores

a

vast

range

of

valuable,

traditional

knowledge

(TK)

because

it

doesn't

meet

the

standards

of

patentability
.



TRIPS
-
CBD Relationship

(Contd..)



TRIPs

undermines

CBD

in

cases

of

biopiracy,

by

putting

the

burden

of

proof

on

the

source

country

rather

than

patentee
.

Identification

of

unique

source

material

as

required

in

Art
.
29

of

TRIPs

is

insufficient
.

Lack

of

transparency

in

the

patent

application

procedure
.



TRIPs

doesn't

require

the

recognition

of

domestic

laws

protecting

access

to

genetic

resources

and

TK

and

subsequent

benefit

sharing
.


The Need to Amend the TRIPs
Agreement



Absence

of

a

clear

reference

to

CBD

and

the

relationship

with

CBD

could

hinder

the

implementation

of

the

latter

by

violating

the

primary

principle

of

sovereignty

over

genetic

resources
.



TRIPs

should

provide

international

recognition

of

relevant

domestic

legislation

of

its

member

countries,

especially

as

far

as

access

and

benefit

sharing

issues

are

concerned
.



The Need to Amend the TRIPs
Agreement
(Contd...)




It

is

far

more

cost

effective

in

the

long

run

to

establish

an

internationally

accepted

solution

through

TRIPs

for

the

prevention

of

biopiracy
.



TK

associated

patents

have

fetched

large

profits

and

it

makes

ethical

and

economic

sense

for

TRIPs

Agreement

to

recognize

a

need

for

benefit

sharing
.



The Need to Amend the TRIPs
Agreement
(Contd...)




It

is

far

more

cost

effective

in

the

long

run

to

establish

an

internationally

accepted

solution

through

TRIPs

for

the

prevention

of

biopiracy
.



TK

associated

patents

have

fetched

large

profits

and

it

makes

ethical

and

economic

sense

for

TRIPs

Agreement

to

recognize

a

need

for

benefit

sharing
.



Bioprospecting and the new IPR regime

Given

the

global

trends

in

capturing

the

intellectual

property

markets,

the

Third

World

nations

in

the

Asia

pacific

now

needs

to

look

ahead

for

the

best

possible

ways

and

means

by

which

they

can

generate

IPR

and

build

up

IPR

covered

bioindustrial

regimes
.


Biotechnology

(BT),

Information

Technology

(IT)

and

Herbal

Technology

(HT)

are

the

three

fast

emerging

and

powerful

areas

of

R&D

in

current

century
.

The

rich

biodiversity,

associated

knowledge

systems

and

human

resources

etc
.

are

the

strength

of

Asia
-
pacific

countries,

and

therefore

have

the

best

opportunity
.

Chemical

Prospecting


Drugs

and

pharmaceuticals


Pesticides


Cosmetics


Food

additives


Other

industrially

valuable



Chemical

products

Bioprospecting

Gene

Prospecting



Genetic

engineering


Crop

development


Fermentation


Cell

culture



Bionic

Prospecting


Designs

Sensor

technologies

Architecture


Bioengineering


Biomodeling


Bioprospecting: Linkages and leads

Biodiversity
& IK/TK

Conservation


Sustainable
use

Benefit
sharing

Bioinformatics


IPR

Biotechnology

Information
technology

Herbal
technology

Bioprospecting


Drug development


Pharmaceuticals


Agrochemistry


Cosmetics


Proteins


Enzymes


New crop varieties


GMOs


GM foods


Designs etc.

IPR Issues / Benefit Sharing

Strategies


Appropriate

Procedures

for

IPR

Protection/Benefit

sharing


Documentation

&

Registration

of

TK



Medicinal

plant

use

&

Conservation

at

local

,

state

and

national

level
.


Contribution

to

TKDL

&

TKRC


Value

addition

to

TK

&

Indigenous

Medicinal

Plants



Scaling

up

IPRs


Herbal

drugs,

Pharmaceuticals,

Natural

products

&

byproducts,

Nutraceuticals,

Functional

foods,

etc
.

Some features of international health care


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


Many currently used modern drugs do not have valid
proven clinical utility.


USA has among the highest per capita annual expenditure
on health care ($3600) but still about 15% population is
denied even basic care facilities (the best Indian state like
Kerala have an annual per capita expenditure ~ $15)

Herbal drugs in international health care


Economic

aspects
:



Global

market

of

herbal

drugs,

Nutraceuticals

~
$
60

billion

with

6
%

annual

growth

rate
.

Major

share

of

Chinese

and

Koreans
.

Indian

share

variously

estimated

at

0
.
35
-
3
.
0
%
.

Chinese

production

increased

200
%

between

1995
-
1999
.


Local

acceptance
:


Developed



USA
:

42
%

use

CAM

spending

over

29

billion

US
$

and

629

million

visits

in

1998
.


UK
:

28
%

use,

spent

1
.
6

billion

pounds

and

127

million

visits

in

1998
.


Australia
:

60
%

use,

A
$

620

billion

in

1999
.


Developing


Malaysia
:

Per

capita

consumption

of

traditional

drugs,

more

than

double

of

modern

pharmaceuticals
.


S
.
Korea
:

Per

capita

consumption

of

traditional

drugs

36
%

more

than

modern

drugs
.

African

countries
:

9

to

10

patients

attending

hospital

OPD

have

first

consulted

a

traditional

healer
.


Advantages of herbal drugs


Modern

drugs

can

produce

serious

side

effects



Latrogenic

diseases

fourth

leading

cause

of

death

in

USA

and

other

developed

nations

(JAMA,

April

1998
)
.



Side

effects

of

drugs

kill

more

Americans

annually

than

the

world

war

II

and

Vietnam

war

combined

(M
.

Rath

N
.

Y
.

Times

28
.
2
.
2003
)
.



Around

2600

persons

died

in

the

Twin

Tower

tragedy

on

11
th

September

2001

causing

global

repercussions
.

It

is,

however,

not

recognized

that

about

the

same

number

die

in

USA

from

side

effects

of

prescription

drugs

every

10

days

(JAMA,

April

1998
)
.


Herbal drugs are best suited for:


PRIMARY HEALTH CARE


INFECTIOUS DISEASES

AIDS and other viral infections

Opportunistic infections

MDR infections (e.g. T.B., Malaria)



DEGENERATIVE & GERONTOLOGICAL
CONDITIONS

Osteoporosis

Chronic arthritis like osteoarthritis and rheumatoid arthritis

Neurological like Alzheimer, Parkinsonism

Anti
-
aging


Metabolic disorders

Diabetes

Dyslipidemias


Other conditions

Microcirculatory disorders

Liver diseases

Immunostimulants

Anti
-
cancer

Drugs affecting male libido

Standardization of Herbal drugs

Raw Drugs


Passport

data

of

Raw

Plant

Drugs

(Crude

drugs)


Correct

taxonomic

identification

&

authentication


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

storage

etc
.


Organoleptic

examination

of

raw

drug
:

Evaluation

by

means

of

sensory

organs
:

touch,

odour

taste


Microscopic

&

molecular

examination


Chemical

composition

(TLC,

GLC,

HPLC,

DNA

fingerprinting)


Biological

activity

of

the

whole

plant


Shelf

life

of

raw

drugs

Standardization of Herbal drugs
-

Herbal Formulation


Follow defined Good Manufacturing Practices
(GMP)


Scientific Verification

Toxicity evaluation

Chemical profiling

Pharmacodynamics


effect of drug in the body

Pharmacokinetics


absorption, distribution,
metabolism, mechanism of action and execution

Dosage

Stability and shelf life

Presentation and Packing

Therapeutic merits


Compared with other drugs


Good Survey of literature (Ancient & Modern)


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 (GCP)


Good Manufacturing Practices (GMP)


Good Marketing Techniques (GMT)

Good Practices/Techniques in Herbal
Products

Physico
-
chemical
value

Parameters required for quality evaluation of herbal drugs

QUALITY EVALUATION OF
HERBAL DRUGS


Standardization & Quality Evaluation of Herbal drugs


Three plants used as ‘
Daruharidra’



In Northern India

Berberis aristata
DC. (Family
-

Berberidaceae),



In Southern part Coscinium fenestratum (Gaertn.) Colebr
(Family
-

Menispermaceae),



In Easter part
Coptis teeta

Wall. (Family
-

Ranunculaceae)



Berberine is the active constituent present in all the three species
thus on the basis of berberine all of these can be used as substitutes
of ‘
Daruharidra’
. However, scientific investigation also suggest that
different
Berberis

species viz.
B. asiatica, B. chitra
and
B. lycium
can also be used as substitute of ‘
Daruharidra’

as all the species
have almost similar chemical profile.


DARU

HARIDRA’

-

A Controversial drug of
Ayurveda


Arabic


-

Ambarbaris

Bhutia

-

Tsema

Bengali


-

Darvi

Canarese


-

Bagisutra

English

-

Indian Barbery, Tree turmeric

Greek


-

Lykion indikon

Garhwal Himalayas

-

Kingora, Kilmora, Kashmal

Hindi


-

Daruhaldi, Darhald, Chitra

Jaunsar


-

Kashmoi

Japanese


-

Indo
-
ohbaku

Latin


-

Berberis

Malayalam


-

Maradarisina, Maramanjal

Nepal


-

Chitra, Chotra

Persian


-

Bedana, Chitra, Zirishk

Punjab


-

Chachar

Himanchal Pradesh

-

Kammul, Kashmal, Kaumul


Sanskrit


-

Daruharidra, Darvi

Tamil


-

Maramanjal, Mullukala

Telugu


-

Kasturipaspu

Urdu


-

Ambar


Different vernacular Names of
Berberis
spp.



Ayurveda
:



It

is

bitter

and

at

the

same

time

hot

and

pungent

useful

in

boils,

diabetes,

affections

of

ear,

eye

and

mouth
.

The

decoction

is

very

useful

preperation

for

opthalmic

infection,

cough,

poison

and

boils
.

Local health traditions (folk remedies) of
Berberis

spp. in Northern India:


B. aristata

DC. and
B. asiatica
Roxb.

:



In

Garhwal region (U. P.) :

In
Dhanulti and Raithal

locality near to
Uttarkashi of U.P. :
Rasaut a root extracts is used for: Eye
conjuctivitiis, Malarial fever, Skin diseases.


In Kumaun region (U. P.) :


In
Ranikhet

locality of Nainital (U.P.) :Decoction of root bark is used in eye troubles. local people
they use root extract for treating fever and skin diseases. Roots are also used for snake and
scorpion bite.


B. Chitria

Lindl.


In

Kangra valley (Himanchal Pradesh):
The filtered decoction of root is used for treating
conjunctivitis and other ophthalmic diseases.


B. Lycium

Royle

In Kangra vally(Himanchal Pradesh):
The decoction of root is given orally as blood purifier. Raw
fruits are also eaten for digestive disorders. Leaves are used as fodder. It is taken with the juice of
radish for jaundice.

Medicinal uses of Berberis spp.


Roots of Berberis spp. are collected in fairly large quantities in Chamba District Of Himanchal Pradesh and in
Tehri
-
Garhwal of Uttar Pradesh during Aug., Sept. and are being sold in the nearby markets or to the traders
which finally reach the drug markets of India.

Different

market

samples

are

identified

as




Trichur

samples

-

Stem

of

Coscinium

fenestratum
.


Banglore

samples

-

Root

of

Coscinium

fenestratum
.


Amritsar,

Aligarh,

Dehradun,

Hyderabad,

Jammu,

Lucknow,

and

Varanasi

samples
-

the

different

Berberis

species
.

Market Survey of Berberis Spp.

N
+
O
O
H
3
C
O
O
C
H
3
Major constituent of Berberis spp.

Berberine

3.55
1.417
2.25
1.024
5.2
1.4
3.99
2.005
0
1
2
3
4
5
6
Root
Stem
Root
Stem
Root
Stem
Root
Stem
B. aristata
B. asiatica
B. chitria
B. lycium
Berberine (%)
B. aristata Root
B. aristata Stem
B. asiatica Root
B. asiatica Stem
B. chitria Root
B. chitria Stem
B. lycium Root
B. lycium Stem
Quantitative Estimation of Berberine in different Berberis species

2.272
1.927
1.45
2.81
3.01
2.27
3.36
3.71
2.18
2.73
0
0.5
1
1.5
2
2.5
3
3.5
4
Locations
Berberine (%)
Aligarh
Amritsar
Bangalore 1
Bangalore 2
Delhi
Jammu
Hyderabad
Lucknow
Trichur
Varanasi
Quantitave estimation of berberine in different market
samples of Berberis spp.

Comparative HPTLC profile of Berberine in different
market samples

Densitometric scan of different samples of Berberis
spp. at UV 266 nm

B
.

aristata

DC
.
,

Syst
.

Nat
.

2
:
8
.
1821
;

Hook

f
.

&

Thomson

in

Fl
.

Brit
.

India

1
:
110
.

1872

pp
.:

Naithani,

Fl
.

Chamoli

1
:
46
.
1984
;

Sharad,

LWG

221239
,

1998
.



Berberis

aristata

DC
.

is

a

large

deciduous

shrub

usually

1
.
8
-
3
.
6

m

high
;

twigs

whitish

or

pale

yellowish

brown,

erect

cylindrical,

smooth

and

strongly

striate
;

blaze

5
-
7
.
5

mm,

bright

yellow

with

coarse

reticulate

fibres
;

leaves

3
.
8
-
10

x

1
.
5
-
3
.
3

cm,

obovate

or

elliptic,

entire

or

spinous
-
toothed,

base

gradually

narrowed,

with

prominent

reticulate

nerves,

glossy

dark

green

above

and

glossy

pale

green

beneath
;

flowers

numerous,

stalked
;

inflorescence

a

simple

drooping

raceme,

bracts

small,

linear,

acuminate
;

sepals

8

or

9
,

imbricate,

oval,

petaloid,

yellow
;

petals

6
,

in

two

whorls,

strongly

imbricate,

concave,

bright

yellow

veined

with

two

oval

linear

glands

at

the

base

of

the

lateral

veins
;

stamens

6

equal,

hypogynous,

opposite

and

slightly

shorter

than

the

petals
;

ovary

simple,

1
-
celled,

with

a

few

erect

ovules
;

style

short,

stigma

peltate
;

fruit

a

small

berry

about

7
-
10

mm,

ovoid

or

oblong

ovoid,

blue

black

with

a

whitish

bloom

tipped

along

with

the

persistent

style

and

stigma
.



Flowering and Fruiting
: August


October



Berberis aristata D.C.


Brief Taxonomic description

Berberis aristata

DC.


Macroscopic & Microscopic


Dried Root

Fruits and Seeds

T.S. of the root (x 100)


T.S. cellular structure of stem (x 100)

TLS of the root (x100)


Powder study (x400)


Botanical Analysis of root of
Berberis aristata
DC

Macroscopic

Woody,

yellowish

brown,

cylindrical,

knotty

with

thin

brittle

bark
.

Cut

surface

bright

yellow

Fracture hard, texture short, odourless and bitter in taste.


Outline

Circular

Cork cells

Brown, 10
-
20 Layered, rectangular

Cortical
zone

30
-
35 layered, parenchymatous, filled with tannin, starch grains and
rhomboidal crystals of Ca
-
oxlate.

Sclereids


Solitary or in group of 2 to 10


Pericyclic
fibres


Mostly solitary but sometimes in groups of 2 to 10.


Alkaloidal
contents


Present

Vessels


Solitary or in group of 2 or 3

Medullary
Rays

Heterogenous, 2 to 4 cells broad, pitted, filled with starch and alkaloidal
content

HPTLC profile and densitometric
chromatogram of
B. aristata

root

Berberine

THE AYURVEDIC THERAPEUTIC
STRATEGY

1.
Determine PRAKRUTI
(Constitution) by
-
history taking

-
observations


2.
NIDANA
(Diagnosis)



Nature, degree and extent of imbalance of
Tridoshas.
Library
of 5800 clinical signs and symptoms in Ayurvedic texts


3.
CHRONOBIOLOGY:
Impact of season, time and
environment on
Tridoshas.


4.
SWASTHAVRUTA:
Life style modification

5.
AHARA:
Dietary modifications


6.
PANCHAKARMA:
Purification of the body


7.
AUSHADHI:
"Designer Medicine" unique for the particular
patient prepared from a Pharmacopoeia utilising 1200 plants,
100 minerals and 100 animal products in numerous
formulations.


OBJECTIVES OF RESEARCH ON
AYURVEDIC DRUGS


Improved

formulations

and

reduced

number

of

Ayurvedic

drugs


Use

of

GMP

procedures

and

QC


Certified

shelf

life

and

improved

dosage

form

Validated

indications

and

contraindications

Deletion

of

obsolete

or

toxic

formulations



Use

of

Ayurvedic

drugs

in

modern

clinical

practice

Inclusion

in

essential

list

of

drugs

Adjunct

to

existing

drugs


Treatment

of

diseases

where

modern

drugs

not

available

or

unsatisfactory


Development

of

suitable

formulations,

standardized

extracts

or

active

constituents

IPR

protection

wherever

feasible

Inclusion

in

Pharmacopoeias
.


New indications for Ayurvedic drugs


Development of new drugs for
Ayurvedic practice


Utilizing leads from other countries


Study of unscreened flora, specially
endemic or threatened species



Studies on Ayurvedic drugs for
veterinary use

OBJECTIVES OF RESEARCH ON
AYURVEDIC DRUGS

Development of new drug/ novel uses
for Ayurvedic drugs


Utilization of new leads on natural products
from other countries. Several of these plants
or related species are found in India


The vast unscreened flora of the country
and published activity data on some of these


Study of further accessions from families
yielding active plants

Vision of Herbal Drug Industry

“To

provide

intellectual

capital

to

make

available

safe,

cost

effective,

affordable

therapeutics

to

the

people

of

Indo
-
Pacific

region



to

help

to

reduce

the

percentage

of

mortality,

morbidity

and

to

emerge

as

significant

players

in

the

global

market

place
.


BIOPARTNERSHIP: RELEVANCE
OF APCTT

Easy

and

regulated

access

to

genetic

resources

&

TK

and

biotechnologies

Exchange

of

information

pertaining

to

conservation

and

sustainable

use

of

biogenetic

resources

and

associated

TK



Mutually

Agreed

Terms



Prior

Informed

Consent



Equitable

Benefit

Sharing

Agreement

APCTT can bring the Asia
-
Pacific Countries
should come together to develop Strategies for
:

Build up S&T Capabilities

Capitalize biodiversity and TK for
bioindustrial development

Insulate from Biopiracy

Ensure national sovereign rights over
biodiversity and TK

Empower local and indigenous communities,
including women

Build up location

specific biodiversity
enterprises using local bio
-
resources and TK
through S&T applications


BIOPARTNERSHIP: RELEVANCE
OF APCTT

APCTT can help Asia Pacific Countries:

AREAS:

Biodiversity & TK


Biotechnology


Bioinformatics


Bioprospecting



BIOPARTNERSHIP: RELEVANCE
OF APCTT

APCTT can help in Capacity building and
Training for Asia
-
Pacific countries

APCTT can help in in Capacity Building and
Training for Asia
-
Pacific countries

STRATEGIES:

1.

Development of Transparent Policies and
Mechanisms to ensure:

Access to and transfer of genetic
resources and technologies among
participating countries

Evolving equitable benefit sharing
models based on sustainable use and S
& T based value addition to bioresources
and associated TK

Contd...

STRATEGIES (Contd.):

2
.

Promotion

of

multi
-
country

collaborative

R&D

projects

on

various

facets

of

Bioprospecting,

particularly

herbal

drug

and

pharmaceutical

prospecting

and

other

natural

product

development

sectors

3
.

Generation

of

IPR
-

covered

products,

processes,

technologies

and

services,

and

thereby

converting

the

bio
-
resources

and

associated

TK

in

to

economic

wealth

of

the

country

and

its

people
.

Action Programme

Important

points

that

the

biodiversity

rich

third

world

nations

should

undertake
:


Complete

inventory

&

documentation

of

all

Biological

resources

including

the

microorganisms


Check

list/database

of

the

floristic

wealth

of

the

nation

along

with

the

associated

knowledge

system


Ground

check

to

know

the

actual

situation

and

identify

the

gaps
:


Study

-

genetic

diversity,

distribution

pattern,

association

pattern

and

gradients


Identify
-

rare,

endemic

and

endangered

status

of

spp
.

,

if

any
.

Action Programme

Prepare

-
passport

data

of

all

important

and

endemic

biodiversity
.

Passport

data

should

cover

morphological,

cytological,

chemical

and

molecular

level

(DNA/gene

level)

information

so

as

to

prevent

bio/gene

piracy
.


Identification

of

problems

and

solutions

in

conservation,

threatened

status

of

species,

ecosystems

-
with

causes

of

threats
.


Identification

of

problems

and

solutions

in

conservation
.