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

1. Division of Forest Products & Utilization, Faculty of Forestry, SKUAST-K
Quality Control
Parameters for
Medicinal plant
Ummar Atta ||Ph. D Scholar|| Credit Seminar

2. Content of Presentation
4321
Introduction
Key highlights
Quality control
Parameters
Case studies
Research done
Conclusion

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.

13. Parameters involved in Quality Evaluation of Herbal
Drugs

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.

23. Continue..
Source: Lakshmi et al., 2016)

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.