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CURRENT SCENARIO OF PLANT
BASED FORMULATION INDUSTRY
INSTITUTION IN INDIA
GUIDED BY: DR.ANANTHA NAGAPPA NAIK
DR.K.S.CHANDRASHEKAR
PRESENTED BY: B.JYOTSHNA DEVI
INTRODUCTION
Generally the terms “medicinal plants” and
“herbs” are used interchangeably. The
traditional or popular name of medicinal
plants varies from country to region
depending on the historical and cultural
aspects.
WHO DEFINITIONS
• Herbs include crude plant material such as
leaves, flowers, fruit, seed, stems, wood,
bark, roots, rhizomes or other plant parts,
which may be entire, fragmented or
powdered.
• Herbal materials include, in addition to
herbs, fresh juices, gums, fixed oils,
essential oils, resins.
• Herbal preparations are produced from
herbal materials by extraction, fractionation,
purification,
concentration, or other physical or biological
processes.
• Finished herbal products consist of herbal
preparations made from one or more herbs.
• Herbal medicines include herbs, herbal
materials, herbal preparations and finished
herbal products, used for medicinal
purposes.
CURRENT SCENARIO
• Use of herbal medicines is wide spread in
developing as well as developed countries.
• Export–Import Bank reports reveal that the
global trade of plant-derived and plant
originated products is around US $60 billion
(with growth of 7% per annum) where India
holds stake of US $1 billion which is expected
to reach 3 trillion US$ by the end of 2015.
WHO
Identified
20,000
species
NAPRALERT
database
documents
ethnomedicin
al uses alone
for 9200 of
33000 species
28 % of plants on
earth have been
used
ethnomedicinally .
Biodiversity
global
71%
india
29%
• Only about 10% of the known medicinal
plants of India are restricted to non-forest
habitats. According to a report , one fifth of all
the plants found in India are used for
medicinal purpose.
• Traditional and folklore healers are sometimes
said to have learned by observing animals. It
has been observed that sick animals prefer to
eat bitter herbs that they would normally
reject.
Percentage demand of 20 major
medicinal plants in the Indian market
A
12%
B
20%
C
11%
D
9%
E
14%
F
34%
• A (Embilica offincinalis)
• B (Asparagus racemosus, Withani somnifera,
Terminalia chebula, Saraca asoca)
• C (Adhatoda Vasica, Cassia angustifolia, Aegle
marmelose)
• D (Piper longum, Bacopa monieri, Sida
cordifolia, Ocimum sanctum)
• E (Bambusa bambos, Boerhaavia diffusa,
Azadirachta indica, Solanum nigrerum,
Andrographis paniculata, Tinospora cordifolia)
• F (others)
MARKET SIZE
• The domestic market for ayurvedic,
herbal and plant based products is
estimated to be around Rs. 3000
crores, growing at 15-20% p.a.
• The share of prescription
formulations is only 20% of the total
market, the balance 80% being
accounted for by OTC products. The
sales of crude herbal drugs and
extracts are of the order of Rs. 350-
400 crores.
1.5
Million
practioners
2000
tones
raw
material
7800
Manufact
-uring
units
HERBS AS SOURCE
• The word drug itself comes from the Swedish
word “drug”, which means 'dried plant'.
examples are quinine from the ‘Cinchona',
morphine and codeine from the ‘Poppy', and
digoxin from the ‘Foxglove'.
• The active ingredient in Willow bark, salacin,
or salicylic acid led to the development of
aspirin, acetyl-salicylic acid, originally a trade
name, patented by Bayer.
MARKET OF MEDICINAL PLANTS
Market
(US$ billion)
Share (%)
Global 16.5 100
Europe 7.5 45
Germany 3.6 22
France 1.8 11
Italy 0.8 5
UK 0.5 3
Spain 0.3 2
Holland 0.1 1
Others 0.4 2
North America 4.0 25
Asia 4.0 25
MEDICINAL PLANT BASED
INDUSTRIES IN INDIGENOUS
SYSTEM OF MEDICINE
• Herbal industry uses about 8000
medicinal plants.
• However, none of the pharma has
standardized herbal medicines
using active compounds as markers
linked with confirmation of
bioactivy of herbal drugs in
experimental animal models.
• The annual turnover of indian herbal industry
was estimated around us$300 million.
• In 1998-1999, it again went up to us$31.7
million.
• In 1999-2000, the total turn over was us$48.9
million.
MANUFACTURER OF HERBAL
FORMULATION
S.NO. NAME OF COMPANY
1 Ansar drug laboratories, Surat
2 Acis labratories, kanpur
3 Allen laboratories, kolkata
4 Dabur India ltd, Gaziabad
5 Herbals Pvt Ltd, patna
6 Herbo (p) Ltd, Kolkata
7 The Himalaya drug Co, Bangalore
8 Indian herbs and research supply Co, Saharnpur
9 Zandu pharmaceuticl works L td, Mumbai
10 Baidyanath ayurveda bhavan, Jhansi
11 Charak pharmaceuticals, Mumbai
12 Kruzer herbal, New Dehli
13 Hamdard (Wakf) laboratories, Dehli
TRADE IN MEDICINAL PLANTS
There is a vast, secretive and largely
unregulated trade in medicinal plants,
mainly from the wild, which continues
to grow dramatically in the absence of
serious policy enforcement and/or
environmental planning.
MEDICINAL PLANT PARTS EXPORTED
FROM INDIA
Botanical names Parts used
Acrus calamas Rhizome
Argemone mexicana Fruit
Curcuma amada Rhizome
Curcuma longa Rhizome
Curcuma aromatica Wild leaves
Cassia lanceolata Leaves
Glycyrrhiza glabra Roots
Withania somnifera Vegetable rennets
Myrica nagi Leaf
Piper longum Fruit
Terminalia chebula Bark and seeds
• India dominates the world market in
production and export of Psyllium husk
and seeds.
• India exports 80% of the psyllium available
in the world market.
• The United States is the world's largest
importer of psyllium "husk" with over 60%
of total imports going to pharmaceutical
firms.
• Metamucil, is India's single largest
customer.
EXPORT GROWTH RATE IN 1999-2000
4% 7%
89%
INDIA CHINA WORLD
SAFETY OF HERBALS
• Safety issues related to herbal
medicine are complex: possible
toxicity of herbal constituents,
presence of contaminants or
adulterants, and potential interactions
between herbs and prescription drugs.
• EXAMPLES:
• kava (Piper methysticum ) is anxiolytic causes
liver damage..
• Extracts of St. John's wort (Hypericum
perforatum) act as an enzyme inducer ,but lead
to a reduction of the plasma level of several
conventional drugs.
• herbal medicines (particularly Asian herbal
mixtures )been shown to be contaminated with
heavy metals, contain misidentified herbal
ingredients that turned out to be toxic.
EFFICACY
Incomplete
data
Range of active
compounds
Clinical trials
QUALITY
• The quality of herbal medicines is often
suboptimal. One reason for this is that they
are not adequately regulated, and many
experts are calling for a change in this
situation.
• Cost-evaluations of herbal medicine are not
available, so they cannot form the basis for
clinical decisions.
EXAMPLES OF SYSTEMATIC REVIEWS AND
META-ANALYSES OF HERBAL REMEDIES
Common
name
Active ingredient Indication No.of trials
Feverfew Parthenolide Migraine
prevention
5(3positive,2
negative)
Garlic Alliin Hypercholest-
erolemia
13(positive)
Ginkgo Ginkgolides,Bilobalide Intermittent
claudication
8(positive)
Horse
chestnut
Triterpene
saponins
Chronic
insufficiency
8/5(8 trail vs
5placebo)
Peppermint oil Menthol Symptoms of
irritable
bowelsyndrome
8(positive)
PATIENT REPORTED OUTCOMES
• Patient–Reported Outcomes (PROs) is the term
used to denote health data that is provided by
the patient through a system of reporting.
• Patient's feedback
• PROs can also be measured when patients are
undergoing treatment or are participating in
a clinical trial.
• PRO data are especially important to evaluating
the effectiveness of health care for conditions
which have no cure, as the goal of treatment
therapy is to improve patients’ abilities to
function and to reduce symptoms associated
with the condition.
• For herbal drugs it is not that convencing due to
insufficiency of knowledge of drug interaction
and their usual use considering them safe.
HERBAL PATENTING IN INDIA
• Developing countries have started exploring the
ethnopharmacological approach of drug
discovery and have begun to file patents on
herbal drugs.
• Pharmaceutical companies such as Ranbaxy,
Lupin and Panacea Biotec are increasingly
patenting on herbal drugs. There is increased
patenting activity related to diabetes, cancer,
cardiovascular diseases, asthma and arthritis in
India and abroad.
List of indigenous plants of India which
were patented in other countries
Name Biological
source
Patent no: patentee purpose
Kumari Aloe
barbadensis
5652265 Michael
Collins
Medicine
Amaltas Cassia fistula 5411733 Toyoharu,
Japan
Antiviral
Harad Terminalia
chebula
5529778 Surendra
Rastogi, India
Ayurvedic
importance
Aswagandha Withania
somnifera
5466452 Whittle, USA Skin disorder
INSTITUTIONS/
CENTRES WORKING
ON INDIAN
MEDICINAL PLANTS
Name City
CCRAS (Central Council for Research in Ayurveda
and Siddha)
New Delhi
RRL (Regional Research Laboratory) (CSIR) Jammu-Tawi
NBRI (National Botanical Research Institute) (CSIR) Lucknow
Gujarat Ayurveda University Jamnagar
Bhavan’s SPARC Mumbai
National Institute of Ayurveda Jaipur
ACARTS Mumbai
Arya Vaidya Shala Kottakal
Interdisciplinary School of Health Sciences Pune
Banaras Hindu University Varanasi
CIMAP (Central Institute for Medicinal and
Aromatic Plants)
Lucknow
ICMR (Indian Coucil for Medical Research) New Delhi
National Medicinal Plants Board New Delhi
Zandu Foundation Mumbai
Pharmexcil Hyderabad
Chemexcil Mumbai
CDRI (Central Drug Researech Institute) (CSIR) Lucknow
ADMA (Ayurvedic Drug Manufacturing Association) Mumbai
Indian Drug Manufacturers Mumbai
Regional Medical Research Centre (ICMR) Belgaum
FUTURE
STRATEGIES/
PERSPECTIVES
FOR INDIAN
HERBAL
MEDICINE
• The plants used in the Indian Systems of
Medicine are of interest to find new
leads for treating different diseases.
• Phytochemical profiling, quality controls
and standardization of raw materials and
finished products, clinical trials, herbal
therapeutics, and herbal
pharmacovigilance will not only help to
prove the rationale of using these
systems but also to get maximum
benefits of the natural resources.
• Proper methodologies for the research
and development, manufacturing and
quality control for the plant based
formulations and investigations of
therapeutic potentials of plants used in
Ayurveda, with the support of scientific
methods may help to use these health
products with maximum possible
efficacy.
BIBLIOGRAPHY
1. Pandey M.M., Rastogi S. & Rawat A.K: Indian Herbal Drug for
General Healthcare: An Overview. The Internet Journal of
Alternative Medicine. 2008 Volume 6 Number 1
2. Schilter B, Andersson C, Anton R, Constable A, Kleiner J, Brien
JO, Renwick AG, Korver O, Smit F, Walker R (2003) Food Chem
Toxicol 41: 1625-1649.
3. Mathur A (2003) Who owns Traditional Knowledge? Working
Paper No. 96 In: Indian Council for Research on International
Economic Relations, January, p. 1-33.
4. Edzard Ernest ; Prescribing herbal medications appropriately;
find article.com.
5. Ashok D.B., Vaidya and Thomas P.A.; Current status of herbal
drugs in India: an overview; JCBN 2007.
6. www.differencebetween.com

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CURRENT SCENERIO OF PLANT BASED FORMULATION INDUSTRY INSTITUTION.pptx

  • 1. CURRENT SCENARIO OF PLANT BASED FORMULATION INDUSTRY INSTITUTION IN INDIA GUIDED BY: DR.ANANTHA NAGAPPA NAIK DR.K.S.CHANDRASHEKAR PRESENTED BY: B.JYOTSHNA DEVI
  • 2. INTRODUCTION Generally the terms “medicinal plants” and “herbs” are used interchangeably. The traditional or popular name of medicinal plants varies from country to region depending on the historical and cultural aspects.
  • 3. WHO DEFINITIONS • Herbs include crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. • Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins.
  • 4. • Herbal preparations are produced from herbal materials by extraction, fractionation, purification, concentration, or other physical or biological processes. • Finished herbal products consist of herbal preparations made from one or more herbs. • Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, used for medicinal purposes.
  • 6. • Use of herbal medicines is wide spread in developing as well as developed countries. • Export–Import Bank reports reveal that the global trade of plant-derived and plant originated products is around US $60 billion (with growth of 7% per annum) where India holds stake of US $1 billion which is expected to reach 3 trillion US$ by the end of 2015.
  • 7. WHO Identified 20,000 species NAPRALERT database documents ethnomedicin al uses alone for 9200 of 33000 species 28 % of plants on earth have been used ethnomedicinally .
  • 9. • Only about 10% of the known medicinal plants of India are restricted to non-forest habitats. According to a report , one fifth of all the plants found in India are used for medicinal purpose. • Traditional and folklore healers are sometimes said to have learned by observing animals. It has been observed that sick animals prefer to eat bitter herbs that they would normally reject.
  • 10. Percentage demand of 20 major medicinal plants in the Indian market A 12% B 20% C 11% D 9% E 14% F 34%
  • 11. • A (Embilica offincinalis) • B (Asparagus racemosus, Withani somnifera, Terminalia chebula, Saraca asoca) • C (Adhatoda Vasica, Cassia angustifolia, Aegle marmelose) • D (Piper longum, Bacopa monieri, Sida cordifolia, Ocimum sanctum) • E (Bambusa bambos, Boerhaavia diffusa, Azadirachta indica, Solanum nigrerum, Andrographis paniculata, Tinospora cordifolia) • F (others)
  • 13. • The domestic market for ayurvedic, herbal and plant based products is estimated to be around Rs. 3000 crores, growing at 15-20% p.a. • The share of prescription formulations is only 20% of the total market, the balance 80% being accounted for by OTC products. The sales of crude herbal drugs and extracts are of the order of Rs. 350- 400 crores.
  • 15. HERBS AS SOURCE • The word drug itself comes from the Swedish word “drug”, which means 'dried plant'. examples are quinine from the ‘Cinchona', morphine and codeine from the ‘Poppy', and digoxin from the ‘Foxglove'. • The active ingredient in Willow bark, salacin, or salicylic acid led to the development of aspirin, acetyl-salicylic acid, originally a trade name, patented by Bayer.
  • 16. MARKET OF MEDICINAL PLANTS Market (US$ billion) Share (%) Global 16.5 100 Europe 7.5 45 Germany 3.6 22 France 1.8 11 Italy 0.8 5 UK 0.5 3 Spain 0.3 2 Holland 0.1 1 Others 0.4 2 North America 4.0 25 Asia 4.0 25
  • 17. MEDICINAL PLANT BASED INDUSTRIES IN INDIGENOUS SYSTEM OF MEDICINE
  • 18. • Herbal industry uses about 8000 medicinal plants. • However, none of the pharma has standardized herbal medicines using active compounds as markers linked with confirmation of bioactivy of herbal drugs in experimental animal models.
  • 19. • The annual turnover of indian herbal industry was estimated around us$300 million. • In 1998-1999, it again went up to us$31.7 million. • In 1999-2000, the total turn over was us$48.9 million.
  • 20. MANUFACTURER OF HERBAL FORMULATION S.NO. NAME OF COMPANY 1 Ansar drug laboratories, Surat 2 Acis labratories, kanpur 3 Allen laboratories, kolkata 4 Dabur India ltd, Gaziabad 5 Herbals Pvt Ltd, patna 6 Herbo (p) Ltd, Kolkata 7 The Himalaya drug Co, Bangalore 8 Indian herbs and research supply Co, Saharnpur 9 Zandu pharmaceuticl works L td, Mumbai 10 Baidyanath ayurveda bhavan, Jhansi 11 Charak pharmaceuticals, Mumbai 12 Kruzer herbal, New Dehli 13 Hamdard (Wakf) laboratories, Dehli
  • 22. There is a vast, secretive and largely unregulated trade in medicinal plants, mainly from the wild, which continues to grow dramatically in the absence of serious policy enforcement and/or environmental planning.
  • 23. MEDICINAL PLANT PARTS EXPORTED FROM INDIA Botanical names Parts used Acrus calamas Rhizome Argemone mexicana Fruit Curcuma amada Rhizome Curcuma longa Rhizome Curcuma aromatica Wild leaves Cassia lanceolata Leaves Glycyrrhiza glabra Roots Withania somnifera Vegetable rennets Myrica nagi Leaf Piper longum Fruit Terminalia chebula Bark and seeds
  • 24. • India dominates the world market in production and export of Psyllium husk and seeds. • India exports 80% of the psyllium available in the world market. • The United States is the world's largest importer of psyllium "husk" with over 60% of total imports going to pharmaceutical firms. • Metamucil, is India's single largest customer.
  • 25. EXPORT GROWTH RATE IN 1999-2000 4% 7% 89% INDIA CHINA WORLD
  • 26. SAFETY OF HERBALS • Safety issues related to herbal medicine are complex: possible toxicity of herbal constituents, presence of contaminants or adulterants, and potential interactions between herbs and prescription drugs.
  • 27. • EXAMPLES: • kava (Piper methysticum ) is anxiolytic causes liver damage.. • Extracts of St. John's wort (Hypericum perforatum) act as an enzyme inducer ,but lead to a reduction of the plasma level of several conventional drugs. • herbal medicines (particularly Asian herbal mixtures )been shown to be contaminated with heavy metals, contain misidentified herbal ingredients that turned out to be toxic.
  • 29. QUALITY • The quality of herbal medicines is often suboptimal. One reason for this is that they are not adequately regulated, and many experts are calling for a change in this situation. • Cost-evaluations of herbal medicine are not available, so they cannot form the basis for clinical decisions.
  • 30. EXAMPLES OF SYSTEMATIC REVIEWS AND META-ANALYSES OF HERBAL REMEDIES Common name Active ingredient Indication No.of trials Feverfew Parthenolide Migraine prevention 5(3positive,2 negative) Garlic Alliin Hypercholest- erolemia 13(positive) Ginkgo Ginkgolides,Bilobalide Intermittent claudication 8(positive) Horse chestnut Triterpene saponins Chronic insufficiency 8/5(8 trail vs 5placebo) Peppermint oil Menthol Symptoms of irritable bowelsyndrome 8(positive)
  • 31. PATIENT REPORTED OUTCOMES • Patient–Reported Outcomes (PROs) is the term used to denote health data that is provided by the patient through a system of reporting. • Patient's feedback • PROs can also be measured when patients are undergoing treatment or are participating in a clinical trial.
  • 32. • PRO data are especially important to evaluating the effectiveness of health care for conditions which have no cure, as the goal of treatment therapy is to improve patients’ abilities to function and to reduce symptoms associated with the condition. • For herbal drugs it is not that convencing due to insufficiency of knowledge of drug interaction and their usual use considering them safe.
  • 33. HERBAL PATENTING IN INDIA • Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. • Pharmaceutical companies such as Ranbaxy, Lupin and Panacea Biotec are increasingly patenting on herbal drugs. There is increased patenting activity related to diabetes, cancer, cardiovascular diseases, asthma and arthritis in India and abroad.
  • 34. List of indigenous plants of India which were patented in other countries Name Biological source Patent no: patentee purpose Kumari Aloe barbadensis 5652265 Michael Collins Medicine Amaltas Cassia fistula 5411733 Toyoharu, Japan Antiviral Harad Terminalia chebula 5529778 Surendra Rastogi, India Ayurvedic importance Aswagandha Withania somnifera 5466452 Whittle, USA Skin disorder
  • 36. Name City CCRAS (Central Council for Research in Ayurveda and Siddha) New Delhi RRL (Regional Research Laboratory) (CSIR) Jammu-Tawi NBRI (National Botanical Research Institute) (CSIR) Lucknow Gujarat Ayurveda University Jamnagar Bhavan’s SPARC Mumbai National Institute of Ayurveda Jaipur ACARTS Mumbai Arya Vaidya Shala Kottakal Interdisciplinary School of Health Sciences Pune Banaras Hindu University Varanasi
  • 37. CIMAP (Central Institute for Medicinal and Aromatic Plants) Lucknow ICMR (Indian Coucil for Medical Research) New Delhi National Medicinal Plants Board New Delhi Zandu Foundation Mumbai Pharmexcil Hyderabad Chemexcil Mumbai CDRI (Central Drug Researech Institute) (CSIR) Lucknow ADMA (Ayurvedic Drug Manufacturing Association) Mumbai Indian Drug Manufacturers Mumbai Regional Medical Research Centre (ICMR) Belgaum
  • 39. • The plants used in the Indian Systems of Medicine are of interest to find new leads for treating different diseases. • Phytochemical profiling, quality controls and standardization of raw materials and finished products, clinical trials, herbal therapeutics, and herbal pharmacovigilance will not only help to prove the rationale of using these systems but also to get maximum benefits of the natural resources.
  • 40. • Proper methodologies for the research and development, manufacturing and quality control for the plant based formulations and investigations of therapeutic potentials of plants used in Ayurveda, with the support of scientific methods may help to use these health products with maximum possible efficacy.
  • 41. BIBLIOGRAPHY 1. Pandey M.M., Rastogi S. & Rawat A.K: Indian Herbal Drug for General Healthcare: An Overview. The Internet Journal of Alternative Medicine. 2008 Volume 6 Number 1 2. Schilter B, Andersson C, Anton R, Constable A, Kleiner J, Brien JO, Renwick AG, Korver O, Smit F, Walker R (2003) Food Chem Toxicol 41: 1625-1649. 3. Mathur A (2003) Who owns Traditional Knowledge? Working Paper No. 96 In: Indian Council for Research on International Economic Relations, January, p. 1-33. 4. Edzard Ernest ; Prescribing herbal medications appropriately; find article.com. 5. Ashok D.B., Vaidya and Thomas P.A.; Current status of herbal drugs in India: an overview; JCBN 2007. 6. www.differencebetween.com