Content of Presentation
Global Market: Share
Indian Medicinal Plant Sector Profile
Area and production of Medicinal and Aromatic plants in India
Why Quality Control?
What is Quality control?
Factors contributing to variation in the content and composition of raw materials.
Quality Control Parameters for Medicinal Plant Materials
Limits of Microbial Contamination : (WHO,2006)
Parameters involved in the Quality Evaluation of Herbal Drugs
The Cost of Poor Quality
Standards for Medicinal plants
Quality control Standards
Quality Demands from Global Markets
Genesis of GAP & GFCP
Criteria for Good Agricultural Practices
Criteria for Good Field Collection Practice
Certification process: At a Glance
Voluntary Certification Scheme for Medicinal Plant Produce (VCSMPP)
Conclusion
Ethnobotany and Ethnopharmacology-Approaches of Traditional Medicine Studies, Traditional use & management of medicinal plants in Asian countries, Application of Ethnobotany to community conservation and medicinal plant resource management
Ethnobotany and Ethnopharmacology-Approaches of Traditional Medicine Studies, Traditional use & management of medicinal plants in Asian countries, Application of Ethnobotany to community conservation and medicinal plant resource management
Ashwagandha is one of the most common herb which is used in several products. So in this ppt we are going to share the important health benefits of ashwagandha with which one can use ashwagandha properly. In order to get best usage of ashwagandha then follow the tips as mentioned in Ppt.
Plants Drug Cultivation:
General introduction to importance pharmacognosy.
Indian Council of Agricultural Research.
Current good agricultural practices.
Current good cultivation practices
Current good collection practices.
Conservation of medicinal plants-Ex-situ & In-situ conservation of medicinal plants.
n Ayurveda, withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means 'that which promotes learning and a good memory' and in geriatric problems.
70-80% of people worldwide rely chiefly on traditional, largely herbal, medicines.
The global demand for herbal medicine is not only large but growing.
Various technologies- adopted for enhancing bioactive molecules in medicinal plants.
Biotechnological tools are important for the multiplication and genetic enhancement of medicinal plants.
In vitro regeneration and genetic transformation are the Techniques adopted.
Global Market For Herbal Products In IndiaANKITA MANKAR
Medicinal plants, also called medicinal herbs, have been discovered and used in traditional medicine practices since prehistoric times. Plants synthesise hundreds of chemical compounds for functions including defence against insects, fungi, diseases, and herbivorous mammals. Numerous phytochemicals with potential or established biological activity have been identified. However, since a single plant contains widely diverse phytochemicals, the effects of using a whole plant as medicine are uncertain. Further, the phytochemical content and pharmacological actions, if any, of many plants having medicinal potential remain unassessed by rigorous scientific research to define efficacy and safety.
The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components.Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted. Standardization, stability and quality control for herbal drugs are feasible, but difficult to accomplish. Further, the regulation of these drugs is not uniform across countries. There are variations in the methods used across medicine systems and countries in achieving stability and quality control. The present study attempts to identify the evolution of technical standards in manufacturing and the regulatory guideline development for commercialization of herbal drugs.
Keywords: survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from companies by email, telephone, and in-person interviews and were analyzed to draw appropriate conclusions.The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin .
Ashwagandha is one of the most common herb which is used in several products. So in this ppt we are going to share the important health benefits of ashwagandha with which one can use ashwagandha properly. In order to get best usage of ashwagandha then follow the tips as mentioned in Ppt.
Plants Drug Cultivation:
General introduction to importance pharmacognosy.
Indian Council of Agricultural Research.
Current good agricultural practices.
Current good cultivation practices
Current good collection practices.
Conservation of medicinal plants-Ex-situ & In-situ conservation of medicinal plants.
n Ayurveda, withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means 'that which promotes learning and a good memory' and in geriatric problems.
70-80% of people worldwide rely chiefly on traditional, largely herbal, medicines.
The global demand for herbal medicine is not only large but growing.
Various technologies- adopted for enhancing bioactive molecules in medicinal plants.
Biotechnological tools are important for the multiplication and genetic enhancement of medicinal plants.
In vitro regeneration and genetic transformation are the Techniques adopted.
Global Market For Herbal Products In IndiaANKITA MANKAR
Medicinal plants, also called medicinal herbs, have been discovered and used in traditional medicine practices since prehistoric times. Plants synthesise hundreds of chemical compounds for functions including defence against insects, fungi, diseases, and herbivorous mammals. Numerous phytochemicals with potential or established biological activity have been identified. However, since a single plant contains widely diverse phytochemicals, the effects of using a whole plant as medicine are uncertain. Further, the phytochemical content and pharmacological actions, if any, of many plants having medicinal potential remain unassessed by rigorous scientific research to define efficacy and safety.
The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components.Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted. Standardization, stability and quality control for herbal drugs are feasible, but difficult to accomplish. Further, the regulation of these drugs is not uniform across countries. There are variations in the methods used across medicine systems and countries in achieving stability and quality control. The present study attempts to identify the evolution of technical standards in manufacturing and the regulatory guideline development for commercialization of herbal drugs.
Keywords: survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from companies by email, telephone, and in-person interviews and were analyzed to draw appropriate conclusions.The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin .
Evaluation of Microbial Quality of Selected Herbal Raw Materials Marketed in ...ijtsrd
Ayurveda medical system is one of the earliest documented health care systems in Asia and it is the second major health care providing service in Sri Lanka. Commercial manufacturing of Ayurveda pharmaceuticals has been legislated for the last six decades. Well documented standards for commercially available herbal raw materials are not regulated in manufacturing process. Therefore, identifying standard parameters for herbal raw materials are highly significant. Microbial quality of commercially available dried fruits of Terminalia chebula, Terminalia bellerica and Phyllanthus emblica that are widely used in various types of Ayurveda pharmaceuticals were evaluated and compared with recommended microbial count with reference to establishing microbial standards of herbal raw materials. Randomly collected dried crushed fruit samples were subjected to evaluate the microbial quality in terms of cfug 1 using pour plate method and spread plate method. Bacterial count of Terminalia chebula, Terminalia bellerica and Phyllanthus emblica were 1.85 x 104, 2.91 x 105and 2.66 x 105 cfug 1 respectively. Yeast and mold count of Terminalia chebula were 2.83 x 104 cfug 1, Terminalia bellerica were 2.9 x 104 cfug 1 and Phyllanthus emblica were 3.03 x 104 cfug 1. Bacterial count of tested samples of Terminalia bellerica and Phyllanthus emblica were higher than the value recommended by WHO for dried powdered herbal materials 1x 105cfu g . Yeast and mold count of tested samples were higher than the recommended value 1x 103cfu g . Improper collection, processing, transportation and storing methods of raw materials could be the reasons for higher microbial count of the samples. Therefore, improving and regulating standards for processing method and supply chain in raw materials is required for enhancing quality, safety and efficacy of herbal pharmaceuticals. Rukmali GM | Udahapuvida BMMSHK | Weerasooriya WMB "Evaluation of Microbial Quality of Selected Herbal Raw Materials Marketed in Sri Lanka" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-2 , February 2021, URL: https://www.ijtsrd.com/papers/ijtsrd38356.pdf Paper Url: https://www.ijtsrd.com/medicine/ayurvedic/38356/evaluation-of-microbial-quality-of-selected-herbal-raw-materials-marketed-in-sri-lanka/rukmali-gm
Standardization of Poly Herbal Siddha Medicine Eladhi Chooranaminventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
Characterization and the Kinetics of drying at the drying oven and with micro...Open Access Research Paper
The objective of this work is to contribute to valorization de Nephelium lappaceum by the characterization of kinetics of drying of seeds of Nephelium lappaceum. The seeds were dehydrated until a constant mass respectively in a drying oven and a microwawe oven. The temperatures and the powers of drying are respectively: 50, 60 and 70°C and 140, 280 and 420 W. The results show that the curves of drying of seeds of Nephelium lappaceum do not present a phase of constant kinetics. The coefficients of diffusion vary between 2.09.10-8 to 2.98. 10-8m-2/s in the interval of 50°C at 70°C and between 4.83×10-07 at 9.04×10-07 m-8/s for the powers going of 140 W with 420 W the relation between Arrhenius and a value of energy of activation of 16.49 kJ. mol-1 expressed the effect of the temperature on effective diffusivity.
Willie Nelson Net Worth: A Journey Through Music, Movies, and Business Venturesgreendigital
Willie Nelson is a name that resonates within the world of music and entertainment. Known for his unique voice, and masterful guitar skills. and an extraordinary career spanning several decades. Nelson has become a legend in the country music scene. But, his influence extends far beyond the realm of music. with ventures in acting, writing, activism, and business. This comprehensive article delves into Willie Nelson net worth. exploring the various facets of his career that have contributed to his large fortune.
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Introduction
Willie Nelson net worth is a testament to his enduring influence and success in many fields. Born on April 29, 1933, in Abbott, Texas. Nelson's journey from a humble beginning to becoming one of the most iconic figures in American music is nothing short of inspirational. His net worth, which estimated to be around $25 million as of 2024. reflects a career that is as diverse as it is prolific.
Early Life and Musical Beginnings
Humble Origins
Willie Hugh Nelson was born during the Great Depression. a time of significant economic hardship in the United States. Raised by his grandparents. Nelson found solace and inspiration in music from an early age. His grandmother taught him to play the guitar. setting the stage for what would become an illustrious career.
First Steps in Music
Nelson's initial foray into the music industry was fraught with challenges. He moved to Nashville, Tennessee, to pursue his dreams, but success did not come . Working as a songwriter, Nelson penned hits for other artists. which helped him gain a foothold in the competitive music scene. His songwriting skills contributed to his early earnings. laying the foundation for his net worth.
Rise to Stardom
Breakthrough Albums
The 1970s marked a turning point in Willie Nelson's career. His albums "Shotgun Willie" (1973), "Red Headed Stranger" (1975). and "Stardust" (1978) received critical acclaim and commercial success. These albums not only solidified his position in the country music genre. but also introduced his music to a broader audience. The success of these albums played a crucial role in boosting Willie Nelson net worth.
Iconic Songs
Willie Nelson net worth is also attributed to his extensive catalog of hit songs. Tracks like "Blue Eyes Crying in the Rain," "On the Road Again," and "Always on My Mind" have become timeless classics. These songs have not only earned Nelson large royalties but have also ensured his continued relevance in the music industry.
Acting and Film Career
Hollywood Ventures
In addition to his music career, Willie Nelson has also made a mark in Hollywood. His distinctive personality and on-screen presence have landed him roles in several films and television shows. Notable appearances include roles in "The Electric Horseman" (1979), "Honeysuckle Rose" (1980), and "Barbarosa" (1982). These acting gigs have added a significant amount to Willie Nelson net worth.
Television Appearances
Nelson's char
WRI’s brand new “Food Service Playbook for Promoting Sustainable Food Choices” gives food service operators the very latest strategies for creating dining environments that empower consumers to choose sustainable, plant-rich dishes. This research builds off our first guide for food service, now with industry experience and insights from nearly 350 academic trials.
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The carbon cycle is a critical component of Earth's environmental system, governing the movement and transformation of carbon through various reservoirs, including the atmosphere, oceans, soil, and living organisms. This complex cycle involves several key processes such as photosynthesis, respiration, decomposition, and carbon sequestration, each contributing to the regulation of carbon levels on the planet.
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Alert-driven Community-based Forest monitoring: A case of the Peruvian Amazon
Quality control parameters for medicinal plants
1. Division of Forest Products & Utilization, Faculty of Forestry, SKUAST-K
Quality Control
Parameters for
Medicinal plant
Ummar Atta ||Ph. D Scholar|| Credit Seminar
3. Key Highlights
Global herbal medicine market size is estimated approximately US $ 120 Billion and is expected
to grow further at 14.88%to reach US $ 7 Trillion by 2050. (Marichamy et al., 2014)
It is estimated that up to four billion people (representing 80% of the world’s population) living in
the developing world rely on herbal medicinal products as a primary source of healthcare.
(Bandaranayake, 2006)
Today Over 25 % of prescribed medicines in developed countries are derived from wild plant
species. (Hamilton,2014)
Demand for wild resources has increased by 8–15 % per year in Europe, North America, and Asia
in recent decades. (Bentley, 2010)
4. Global Market: Share
The largest global markets for medicinal and aromatic plants (MAPs) are China, France, Germany, Italy,
Japan, Spain, the UK and the USA.
Europe is the largest herbal product market worth US $7.5 Billion. Germany and France are the region’s
market leaders with shares 28% and 24% respectively In Eastern Europe, Poland is the main and
growing market the apprx estimate of the Polish market is US $681 Million.
In Asia, Japan alone is valued at US $2.6 Billion and China US $8 Billion. Japan has the highest per
capita consumption of botanical medicines in the world.
China is the major exporter of medicinal plants accounting to 15% of total medicinal plant export
globally. India ranks second globally in exports contributing0.5 % only.
Source: UNIDO, 2008
5. Indian Medicinal Plant Sector Profile
Indian trade value of herbal raw drugs in commercial demand reached
the US $856 Million growing at 17.82% since last 10 years.
(Bhandari, 2017)
About 4000 Plant Species are use in all the Codified System of
Medicine practices in India. (Bhandari, 2017)
About 1178 medicinal plant species recorded in the practices of trade.
242 plant species recorded in high annual trade. Japan, Europe and US
are key export destinations for herbal raw drugs in India. (NMPB)
Opium, Senna, Psyllium are major commercial crops which are
presently being produced on very large scale. (NMPB)
The Commercial demand of herbal raw drugs for the year 2015-16 was
5,12,000 MT. (Chowti et al., 2018)
The total exports of Herbal Raw Drugs, including Extracts was
estimated and it was 1, 34, 500 MT. (Chowti et al., 2018)
Ayurveda, 1487
Siddha , 1128
Unani, 503 Sowa-Rigpa,
253
Homoeopathic,
437
Western , 192
(Source: Bhandari, 2017)
6. Area and production of Medicinal and Aromatic
plants in India (Area: 000’ha, Production: 000’t)
0
200
400
600
800
1000
1200
Area Production
01
02
03
Area
The area under Cultivation of MAPs has increased from 2,
62, 000 hectares during 2005-06 to 6, 33, 900 hectares in
2015-16. with the annual growth rate of 1.12 per cent per
annum. .
Production
The production has increased from 2, 02, 000 tons in 2005-
06 to 10, 22, 500 tons with an annual growth rate of 2.76
per cent per annum.
State share
Rajasthan is having highest area under these crops with a
share of 56 per cent (average 3, 03,630 ha) followed by
Uttar Pradesh (25 %). Incase of production, Madhya
Pradesh ranks first with a share of 44 per cent and
Rajasthan ranks second with a share of 19 per cent. The
states like Tamil Nadu, Chhattisgarh and Arunachal
Pradesh were having a share of 16 per cent, 8 per cent
and 7 per cent respectively.
Source: www.nmpb.nic.in
7. Why Quality Control?
Indian share to global herbal medicinal market is only 1.2%. The Major reasons for this is the lack of proper
quality, safety and efficacy.
Indian herbal drug industries face two major problems;
Adulteration & Substitution
Eg, In the name of “Talispatra” an important Ayurvedic drug, different leaves of Taxus wallichiana, Abies
spectabilis and Rhododendron anthopogan are being sold in Dehradun, Kolkata and Amritsar markets,
respectively.
The lack of confidence in the quality of drug in the herbal medicine is hindering us from capitalizing these
systems at global level.
Source: Rawat,2013
8. What is Quality control?
Quality Control is a term refers to processes involved in maintaining the quality or validity of a manufactured
product.
some degree of quality control should exist, Regardless of the form of herbal preparation, Without proper
quality control, there is no assurance that the herb contained in the package is the same as what is stated on
the outside label.
To achieve Quality
• Harvesting schedules,
• Cultivation techniques,
• Storage,
• Activity & stability of active compounds.
WHO, 2008
9. Factors contribute variation in the content and
composition of raw materials.
HEADING
Prevailing temperature,
rainfall, humidity, daylight
& altitude of the growing
region.
Climatic factors
HEADING
Several soil factors
like availability of
micro & macro
nutrients, pH & CeC,
are important for
optimal growth of
plants.
Nutritional factors
HEADING
Control the content of
active components by
giving attention to the
Age,
Season,
Collection time &
The plant organ
Collection factors Post-harvest
factorsHEADING
The enzymatic processes
continue after collection
until they are deactivated
by drying or other suitable
treatment, as the collected
material is still live and
carries out metabolic
processes and respires.(Source: Liu et al., 2015)
10. Continue..
All or some of these factors can affect the
Safety,
Efficacy &
Quality of any herbal drug.
11. Quality Control Parameters for Medicinal Plant Materials
1. Authentication,
2. Foreign matter,
3. Organoleptic evaluation,
4. Tissue of diagnostic importance present in the
drug,
5. Ash values & extractive values,
6. Volatile matter,
7. Moisture content determination,
8. Chromatographic & spectroscopic evaluation,
9. Determination of heavy metals i.e Hg, lb, cd,
Ar etc,
10. Pesticide residue,
11. Microbial contamination,
12. Afflatoxins should be completely removed or
should not be present,
13. Radioactive contamination.
World Health Organization (WHO) in its volume Quality control methods for medicinal
plant materials (1996, lastly reviewed in 2006) Listed several parameters which are
valuable in assuring quality of plant drugs. These include
12. Limits of Microbial Contamination : (WHO,2006)
UNDER ACCEPTABLE HYGIENIC CONDITIONS:
1. Escherichia coli, maximum 104
/g
2. Mould propagules, maximum 105
/g
for plant materials that have been pre-treated (e.g. with boiling water as used
for herbal teas and infusions)
1. Aerobic bacteria, maximum 107
/g
2. Yeasts and moulds, maximum 104
/g
3. Escherichia coli, maximum 102/g
4. Other enterobacteria, maximum 104
/g
5. Salmonellae - none.
FOR OTHER PLANT MATERIALS FOR INTERNAL USE:
1. Aerobic bacteria, maximum 105/g
2. Yeasts and moulds, maximum 103/g
3. Escherichia coli, maximum 10/g
4. Other enterobacteria, maximum 103
/g
5. Salmonellae, none.
As perAPI:
1. taphylococcus aureus/g. - Absent
2. Salmonella sp./g. - Absent
3. Pseudomonas aeruginosa/g - Absent
4. Escherichia coli - Absent
5. Totalmicrobial plate count (TPC) - 105
/g*
6. TotalYeast & Mould - 103
/g
Different limits are set according to the use of the material and the material itself.
14. The Cost of Poor Quality
Valeriana wallichii
CEO, COMPANY NAME
Valeriana wallichii;High altitudespecies-2years Gestation
Average yield of Dry Roots: 633mg per plant
15,79,778 plantsneeded to provide 1.00 MT of Raw material
Quantumof Loss if rejected on Quality Grounds??
Source: Rawat, 2013)
15. Standards for Medicinal plants
Establishment of internationallyaccepted standardsis certainly one of the priories for the future
of medicinal plants.
Standardsare necessary at three different levels:
a. Quality control of herbal products,
b. Preclinical evidences of safety and efficacy, and
c. Clinical evidences of safety and efficacy.
Source: Efferth and Greten, 2012)
16. Quality control Standards
DNA-based technologies
Methods of plants identification are recently supplemented by
various DNA-based technologies, including
• RAPD, RFLP, CAPS, AFLP, DAF, etc
A recently technological development is the authentication of
medicinal plants by barcode DNA. This method is based on the
detection of variable sites of the rDNA .
The largest data base on DNA barcodes of medicinal plants,
with more than 1000 spp. listed in the Chinese pharmacopoeia.
DNA barcoderesults from blind testing of the 44 herbal products
representing 30 medicinal species of plants. (Newmaster et al., 2013)
17. Continue..
Good practice guidelines
Having a correctly identified plants in hand, they have to be further handled in a standardized manner. For this
reason, International guidelines have been developed such as:
• Good Sourcing practice (GSP),
• Good Agriculture Practice (GAP),
• Good Laboratory Practice (GLP),
• Good Manufacturing Practice (GMP),
• Good clinical Trial Practice (GCTP).
Source: Efferth and Greten, 2012)
18. Continue..
Chemo profiling
A number of chromatographic fingerprint analyses are known to disclose the detectable ingredients composition
and concentration distribution. Standard analytical techniques include TLC/HPLC.
Fig 2. (A&B) TLC fluorescent images from two samples of Ginseng from different sources showing lack
of standardization for the ginsenosides Rb1, -R0, -Rg1, -Re, and Rd profile. Sample B was not cultivated
properly probably by using extra quantities of chemical fertilizer. (Source: Boylan, 2011)
Figure 1: HPLC profiles of methanol extracts of Aconitumheterophyllum
Wall. Ex Royle. and Cyperus rotundusL. (Source:Venkatasubramanian,et al
2010)
19. Continue..
Toxicology
Another aspect of Quality control, is to avoid
contamination with mycotoxins, pesticides, heavy
metals etc.
Adulteration of drugs from Western medicine, eg. With
glucocorticoids have to be banned.
The recommended permissible limit for Mercury, Lead,
Cadmium, and Arsenic are 1mg/kg, 10mg/kg, 0.3mg/kg
and 3mg/ kg respectively.
(Source: Zang et al., 2012)
20. Continue..
Monographsand pharmacopeias
Monographs contain definitions, analytical techniques for identity
and purity and content, as well as storage regulations for all kinds
of drugs (herbal, chemical, biological).
Indian Pharmacopeia, European Pharmacopeia, American Herbal
Pharmacopeia, German Pharmacopeia, the Chinese
Pharmacopeia, and etc.
Each pharmaceutically employed drug has to meet the
requirements of the monograph.
Source: IP report 2018)
21. Continue..
Preclinical Evidences of safety and efficacy
Preclinical studies refer to the testing of a herbal drug, procedure or other medical treatment in animals before trials
may be carried out in humans. During preclinical herbal drug development, the drug’s toxic and pharmacological effects
need to be evaluated through in vitro and in vivo laboratory animal testing.
Ulcerative colitis is a chronic inflammatory condition whose treatment includes aminosalicylates and corticosteroids.
The families Asteraceae and Lamiaceae presented the largest number of studies, but plants from several other families
were shown good results in Preclinical trials . However, only a few species (such as Andrographis
paniculata and Punica granatum) have undergone clinical tests against ulcerative colitis. (Santana et al., 2017)
Source: Efferth and Greten, 2012)
22. The pus samples from diabetic foot ulcer patients and urine samples from urinary tract infected
patients were collected and inoculated in nutrient agar plates.
The antibacterial assay of selected commercial antibiotics was tested against the foot ulcer and
urinary tract isolates.
The result revealed that most of the organisms were found to be resistant against the antibiotics.
Screening of antibacterial activity of selected plants, methanol extracts of plants were prepared
and tested against foot ulcer pathogens.
Among the plants used, the methanolic extract Tragia involucrata was very effective against the
foot ulcer pathogens. Allium sativum inhibited the growth of the pathogens isolated from urinary
tract infection.
24. Continue..
Clinical Evidences of Safety and Efficacy
Clinical trials are conducted to collect data regarding the safety and efficacy of new herbal drug. There are four phases
of approval in the clinical trials.
Phase I studies assess the safety of a drug . This initial phase of testing, which can take several months to complete,
usually includes a small number of healthy volunteers (20 to 100).
Phase II studies test the efficacy of a drug. This second phase of testing can last from several months to two years, and
involves up to several hundred patients.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale
testing, which can last several years, provides the pharmaceutical company more thorough understanding of the
effectiveness of the drug or device.
Phase IV studies, often calledPost Marketing Surveillance Trials, are conducted after a drug or device has been
approved for consumer sale.
Once evidence-based traditional medicines are on the market, pharmacovigilance studies are required for monitoring
the adverse effects.
Source: www.ayush.gov.in
25. Obvious need of GAP
A Quality management system integrating:
• Quality(ofend products)
• Sustainability(ofresources)
• Economic benefits/ Social benefits (to the producers/collectors)
A Quality Management SystemApplicablefor Wild & Cultivated Sources.
Specific for Medicinal Plants Sector.
• Prevailing QMS/Certification process have limitation for medicinal plants.
(Source: Prakash, 2014)
26. Quality Demands from Global Markets
Purity Requirements:center-stage
Sourcing practice: Transparent,Healthy and Sustainable
Consistency in Phyto-chemical Profile
• Quantification of Markers/ Functional groups
• ChromatographicFingerprinting
Residual Pesticiseds
Trace elements
Aflatoxins & Ochratoxins
(Source: Prakash, 2014)
27. Genesis of GAP & GFCP
WHO Guidelines for Good Agricultural & Field Collection of Medicinal Plants
• Year 2003
Indian Specific Guidelines by National Medicinal Plant Board
• Bifurcation of Guidelines (2007-08)
Collaboration with QCI & Development & Adaptations of Standards of GAP & GFCP
• 2009
Current Status
• Consultation Completed on “Certification Processes”
• Scheme accepted by NMPB
• Voluntary Certification Scheme of Medicinal Plants Produce (VCSMPP) launched on
• 21st-Nov-2017
(Source: www.qcin.org/ www.nmpb.nic.in)
28. Criteria for Good Agricultural Practices
Site Selection & Metrological data
Soil Conditions
Seeds & Propagation Materials
Crop Management
Harvest & Post harvest Management
Identification & Traceability
Personnel & Equipment
Workers Health, Safety & Welfare
Record Keeping
Self-Assessment/ internal Audit
(Source: WHO, Guidelines (GACP) for Medicinal Plants, 2003)
29. Criteria for Good Field Collection Practice
Site Selection: Qualitative & Quantitative sustainability
Compliance to Regulatory requirements
Collection Management
Post Harvest management
Packaging & Storage
Machinery & Equipment
Identification and Traceability
Training and monitoring
Workers Health, Safety & Welfare
Record Keeping and Internal Assessment
(Source: WHO, Guidelines (GACP) for Medicinal Plants, 2003)
30. Certification process: At a Glance
Scheme ownership
• NMPB, Department ofAYUSH, GoI.
Custodian ofScheme
• Quality Counsel ofIndia.
Beneficiaries
• Cultivators/collectors, Traders, Manufacturers ofHerbal medicine, Societies & AYUSH industry.
Production Certification through Process Evaluation
• One lot ofProduction (under GAP) or Collection (under GFCP)
• Options for Continuous Certification: Under Consideration
Site Audit/ Evaluation
• Single time Audit
• Linked to harvesting Cycle
Process Designed to Promote the Concept
• Adequate consideration to Certification Cost
(Source: www.qcin.org/ www.nmpb.nic.in)
31. Voluntary Certification Scheme for Medicinal Plant Produce
(VCSMPP)
Renewal of
Certificate
Market Sampling
Periodic Surveillance
Evaluation
Grant of Certificate
Registration for Application
Evaluation (s) at the Site
Testing of Sample (s)
05
06
07
01
02
03
04
Certification
Process
(Source: www.qcin.org/ www.nmpb.nic.in)
32. Additional Benefits
Cycle Matrix & Cubes for PowerPointSea Shell Diagram
01
02
03
04
Reduced Risk of recall/ rejection,
Assured Legal compliance,
Increased buyer confidence in Indian herbs,
Assured sustainable collection.
33. HPLC fingerprint profiles of three
samples of Epimedii Herba of different
habitats show that plant taxonomical
equivalence does not always mean Phyto-
chemical equivalence.
This approach offers the feasibility of
characterizing and quality-controlling
complex samples in the same genus
designated under a single herbal drug
entity on the premise of possessing the
same bioactive ingredients pattern and
supported by long-term traditional
usage.
Figure 1. HPLC fingerprint of Epimedii herba (Yin-Yang-Huo) grown in different habitats.
(2) epimedin A, (3) epimedin B, (4) epimedin C, (6) icariin. The three samples from the
Anhui province showed none of the main bioactive flavonoids detected in “species
Identifier region” of its HPLC fingerprint.
34. Swertia spp. (Gentianaceae) commonly known as Chiraita in herbal drug markets of India is used to protect liver and a
wide range of diseases. The official species Swertia chirayita (Roxb.) Karsten is known for its potent activity against
malaria, liver-disorder, fever, diabetes and also as appetite stimulant.
Several other species of Swertia viz. S. alata (Royle ex D. Don) Clarke and S. paniculata Wall. are being used as
substitutes /adulterants for S. chiraita in India, Japan, China, Pakistan and other Asian Countries.
35. Continue..
1. There are some minor variations in the
microscopic charactersas, no
appearanceof cavity in the pith region
of stem in S. alata and S. paniculata
while cavities present in premedullary
region of S. chirayita.
Figure 1. Comparative Microscopic descriptors of three Swertia species Abbreviation: Stem - ct-cortex,
cu- cuticle, end- endodermis, epi-epidermis, pi-pith, wi-winged extension, xy-xylem,Ph-Phloem, St-
Seive tube, Cav-Cavity.
Leaf-Le-Lower epidermis, Ue-Upper epidermis,Cu-Cuticle, Mes. Par- Merophyll parenchymatous.
36. Continue..
Studies shows that S. chirayita has almost
maximum percentage of all the
physicochemical parameters (total ash
5.30%, ethanol soluble extractive 41.60%,
water soluble extractive 31.60%) except
starch and sugar which were highest in S.
alata.
Fig 2. Comparative Physico chemical valuesof Three Swertia species(Source: Rawat et al., 2011)
37. Types of Adulterant
1. Substitution with substandard commercial varieties :
Source: Kumar & Ruba, 2018
S.no Drug Family Material Substituted Family
1 Strychnus nux-vomica Loganiaceae Strychnus potatorum Strychnus
nux-blanda
Loganiaceae
2 Cassia angustifolia Fabaceae Cassia abovata Cassia auriculata Fabaceae
3 Jamaica zinger Zingiberaceae. African, Japanese &Cochin
Ginger
Zingiberaceae
4 Aconitum heterophyllum Ranunculaceae Cryptocoryne spiralis Araceae
5 Rauwolfia serpentina Apocynanceae Rauwolfia canescens Rauwolfia
vomitora Rauwolfia hirsuta
Apocynaceae
6 Saraca indica(bark) Fabaceae Trema orientalis Polyalthia
longifolia
Annonaceae
38. Continue..
2. Substitution with superficially inferior material 3. Substitution with harmful adulterants
Source: Kumar & Ruba, 2018
S. No Drugs Substituted material without medicinal
value
1 Black pepper Papaya seeds
2 Coffee powder Tamarind seed powder
3 Black mustard seeds Argemone seeds
4 Saffron Carthamus tinctorius
5 Clove buds Clove stalk and dried leaves
6 Coriander powder Faecal matter of donkey
7 Cinnamon bark Cassia
8 Bees wax Japan wax
9 Senna leaves-Cassia
angustifolia
Leaves of Cassia auriculata
S. No Drugs Harmful adulterent
1 Piece of amber Colored glass
2 Asafoetida Limestone
3 Opium Lead shot
4 Coconutoil Coco butter is adulterated with
stearin or paraffin
5 Cardamom seed Rodent feacal matter
6 Glycyrrhiza glabra
(roots)
Stones
7 Benzoin Small sized stones and
sandy/earthy material
8 Silver grain cochineal Barium sulphate
9 Black grain cochineal Manganese dioxide
39. Conclusion
For assuring high qualityof Medicinal plants theremust be a rigorous implementation of
GACP and GMP which can minimize the risk of contamination, adulteration and other
problems.
India specific Good Agricultural Practices (GAPs), Good Harvesting Practices (GHPs)
need to prepared by National Medicinal Plant Board (NMPB) .To achieve the overall
improvement of quality, efforts should be made to deepen methodological researches and
enhanceregulatory in herbal medicines.
Efficacy must be proven by double blind controlled trials. Analytical/chromatographic
methods need to be developed for high qualityherbal materials which will facilitate both
qualitative and quantitative estimation of ingredients.
Advancement in pre-clinical and clinical evidences of safety and efficacy will foster their
integration into western medicine.