Transcript Herbal technology – challenges and opportunities for India

Herbal technology – challenges
and opportunities for India –
CSIR experience
P. Pushpangadan
National Botanical Research Institute
Rana Pratap Marg, Lucknow-226001
21st Century
21st 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)
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.
HERBAL DRUGS : RESURGENCE,
OPPORTUNITY AND COMPETITION
WORLD-WIDE
THE USE OF PHYTOPHARMACEUTICALS
IS INCREASING @ 15% AGAINST 3% FOR
MODERN PHARMACEUTICALS.
U. S. A.
THE NUMBER OF PEOPLE USING HERBAL
PRODUCTS ROSE BY 50% LAST YEAR.
CHINA
35% OF OUT PATIENTS AND 22% OF
INPATIENTS USE T.C.M. 940 HERBAL DRUG
MANUFACTURING UNITS. HERBAL DRUG
PRODUCTION ~ 18 BILLION CHINESE
YUAN (DOMESTIC MARKETS). SALE OF
HERBAL MEDICINE HAS 33% OF THE
TOTAL DRUG MARKET.
Handa 2003
INDIA
60-70% POPULATION USE DRUGS
INDIAN SYSTEM OF MEDICINES.
OF
JAPAN
147 HERBAL MEDICINES ARE ELIGIBLE BY
NATIONAL HEALTH INSURANCE SCHEME
GERMANY
DOES NOT DIFFERENTIATE BETWEEN
PHARMACEUTICALS AND PHYTOPHARM ACEUTICALS.
AUSTRALIA
ANNUAL EXPENDITURE ON ALTERNATE
MEDICINES AU $ 621 MILLION.
R.P.D. KOREA
HERBAL MEDICINE OUTPUT OVER US $
500 MILLION WHICH ACCOUNT FOR 12%
OF THE TOTAL DRUG OUTPUT.
SINGAPORE
12% OF THE DAILY OUTPATIENTS VISIT
T.M. PRACTITIONERS.
Handa 2003
GLOBAL MEDICINAL PLANTS PRODUCT MARKET
NUTRACEUTICALS
HERBAL DRUGS
US $ 250 BILLION
REGION
US $ 12.4 BILLION
% MARKET SHARE
ECM
48
REST OF EUROPE
03
JAPAN
17
REST OF ASIA
20
NORTH AMERICA
12
% SHARES IN US HERBAL PRODUCT MARKET
CHINESE HERBS
18.7%
HERBAL TEA
14.5%
OTHER ASIAN PLANTS
6.0%
LOCAL AND OTHER IMPORTS
60.8%
REF P. Brevoort, 1997
GLOBAL SALE OF HERBAL DRUGS
(BILLION US $; RETAIL)
EUROPE
7.0
8.9
1.9
27
ASIA
5.1
6.0
0.9
17
N.AMERICA
3.8
4.5
0.7
18
AUSTRALASIA
0.12 0.14 0.02 17
AFRICA +
MIDDLE EAST
0.19 0.21 0.02 24
S. AMERICA
0.6
E. EUROPE
0.37 0.40 0.03
REST OF WORLD
0.2
0.83 0.23 38
0.3
0.1
8
30
WORLD PHYTOPHARMACEUTICAL MARKET
PLANT-DRUG
CATEGORY
SALE VALUE (Million US $)
1997
2002
AAGR %
TERPENOIDS
7,660
12,400
10.1
GLYCOSIDES
7,300
9,230
4.8
ALKALOIDS
3,600
4,045
2.4
OTHERS
4,048
5,013
4.4
TOTAL
22,608
30,668
6.3
SOURCE : BUSINESS COMMUNICATION COMPANY INC.
SALE OF HERBAL MEDICINES IN DIFFERENT
REGIONS OF THE WORLD
REGION
SALE VALUE (BILLION US $)
1994
1997
1999
2002 *
EUROPE
6.00
7.00
7.00
8.90
NORTH AMERICA
1.50
1.60
3.80
4.50
JAPAN
1.80
2.40
2.20
2.90
ASIA
2.70
2.20
5.10
6.00
AUSTRAL-ASIA
-
-
0.12
0.14
AFRICA & MIDDLE EAST
-
-
0.19
0.21
LATIN AMERICA
-
-
0.60
0.83
EASTERN EUROPE
-
-
0.37
0.40
REST OF WORLD
0.50
0.80
0.20
0.30
TOTAL
12.40
14.00
19.58
24.18
* Estimates
Source : IMS 1994; Gruenwald, 1997; Gruenwald, 2000
MOST FREQUENTLY PRESCRIBED MONOHERBAL PREPARATIONS IN GERMANY
Herbal drugs
Botanical source
Therapeutic class
Ginkgo
Horse chestnut
Yeast preparations
St. John’s wort
Myrtle
Stinging nettle
Saw palmetto
Milk thistle
Ivy leaf
Mistletoe
Soy beans
Chamomile
Comfrey
Kava-kava
Greater celandine
Ginkgo biloba
Aesculus hippocastanum
Fungal Source
Hypericum perforatum
Myrtus communis
Urtica dioica
Serenoa repens
Silybum marianum
Hedera helix
Viscum album
Glycine max
Matricaria chamomilla
Symphytum officinale
Piper methysticum
Chelidonium majus
Circulatroy agent
In varicose veins
Antidiarrhoel
Antidepressant
Cough suppressant
Urologic
Urologic/Prostrate
Urologic
Cough suppressant
Cancer treatment
Dermatological uses
Dermatological uses
Dermatological uses
Tranquillizer
Gastrointestinal
treatments
Anti-inflammatory,
proteolytic
Cold remedy
284
70
36
36
22
20
19
18
18
14
9
9
8
8
8
Gynaecological uses
6
Bromelain (from
Ananas comosus
Pineapples)
Cineole (essential
Eucalyptus spp.
oil)
Black cohosh
Cimicifuga racemosa
Source: RIRDC, 2000
Retail sale value
(million US$)
7
7
DEMAND FOR AYURVEDIC AND UNANI
MEDICINES FROM TOP 11 COUNTRIES
COUNTRY
VALUE COUNTRY
(m.us$)
FRANCE
ITALY
NETHERLANDS
SINGAPORE
UKRAINE
USA
0.32
0.60
0.46
0.61
0.40
0.49
GERMANY
MALASIA
RUSSIA
SWITZERLAND
UNITED ARAB EMIRATES
TOTAL
SOURCE:
VALUE
(m.us$)
PHARMABIZ 2001
0.29
0.74
0.48
1.14
0.54
8.8
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 11th 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
Challenges ahead
The major challenge is quality control and
standardization
Scientific validation of the therapeutic
claims
Safety
Customer satisfaction and confidence
Three pillars of ideal herbal drug
and their
rational
use
QUALITY
APPROPRIATE
USE OF
Herbal Drug
QUALITY
SAFETY
EFFICACY
ACCESSABILITY
AVAILABILITY
SAFETY
EFFICACY
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 drugsHerbal 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 Practices/Techniques in
Herbal Products
 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)
Physico-chemical
value
Parameters required for quality evaluation of herbal drugs
Standardization & Quality Evaluation of Herbal drugs
QUALITY EVALUATION OF
HERBAL DRUGS
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.”
Problems faced by Indian Traditional
Medicine
• Reluctance to accept adopt and assimilate modern
scientific methods and tools,
• Lack of consistency in quality in batch to batch
products
• Absence of standardization
• Lack of systematic scientific documentation of the
herbal drugs
• Rare and endangered position of many important
medicinal plants
CSIR initiatives in Traditional Medicine
•
20 laboratory networked programme on discovery
of bioactive molecules mainly based on the clues
from traditional medicine.
•
New Millennium India Technology Leadership
Initiative (NMITLI) Programme. In this a number of
non CSIR laboratories and pharmaceutical
industries are also joining hands. It is intended to
establish pharmacoepidemeological evidence
base to Ayurvedic medicines, practice and
development of standardized herbal formulations.