WHO and ICH Guidelines For The Assessment of Herbal Drug

International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 6 Issue 3, March-April 2022 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
WHO & ICH Guidelines for the Assessment of Herbal Drug

Ms. Bhadane Suvarna1, Dr. Takarkhede Smita2, Ms. Kakade Pooja3,
Ms. Jaiswal Sangeeta3, Ms. Kanaujiya Shreya3, Ms. Khan Alqama3
1
Faculty of Ideal College of Pharmacy and Research Kalyan Mumbai,
2
Principal of Ideal College of Pharmacy and Research,
3
Student of Ideal College of Pharmacy and Research,
1, 2, 3
Ideal College of Pharmacy & Research, Kalyan Affiliated by University of Mumbai, Maharashtra, India
ABSTRACT How to cite this paper: Ms. Bhadane

The medicinal plant and herbal drugs products are widely used for Suvarna | Dr. Takarkhede Smita | Ms.
thousands of years in all over the parts of the world. The word Kakade Pooja | Ms. Jaiswal Sangeeta |
"herbal drugs" denoted plant parts or plants. Ms. Kanaujiya Shreya | Ms. Khan
Alqama "WHO & ICH Guidelines for
That is converted into phytopharmaceuticals by means of straight the Assessment of Herbal Drug"
forward processes including harvesting, drying, and storage. In recent Published in
few decades, growth and recognition of herbal medicine and plant International Journal
products have taken a big share of healthcare. of Trend in
Scientific Research
There's the increasing awareness and general acceptability of the use and Development
of herbal drugs in today's practice Although, most of these (ijtsrd), ISSN: 2456-
applications are unorthodox, it's however known fact that all over 6470, Volume-6 | IJTSRD49571
80% of the world population are depends on herbal medicine and Issue-3, April 2022,
products for healthy living Where standardization and control with pp.549-559, URL:
proper integration of recent scientific techniques and lore is www.ijtsrd.com/papers/ijtsrd49571.pdf
incredibly important. This rise within the utilization of herbal product
has also given to numerous forms of adulteration and abuse of the Copyright © 2022 by author(s) and
International Journal of Trend in
products leading to consumers and manufacturers disappointment.
Scientific Research and Development
The challenge is innumerable and making the worldwide herbal Journal. This is an
market unsafe Evaluation of herbal drug showing an important and Open Access article
vital tool within the formulation of high-quality herbal products. distributed under the
Herbal drug technology mainly used for converting botanical terms of the Creative Commons
materials into medicines. Attribution License (CC BY 4.0)
(http://creativecommons.org/licenses/by/4.0)
KEYWORDS: WHO parameters, ICH guidelines, Standardization,
Herbal drug
INTRODUCTION
The International Conference on Harmonisation efficacy and quality of herbal medicines are of almost
(ICH) is established in 1990 for Registration of importance. The most colour of the logo or emblem is
Prescription drug for Human Use World Health blue, a color often used with healthcaredicines.
Organization (WHO) Established in 1948 for Standardization of drug means to confirmation of its
international health matters and public health has set identity, quality and purity throughout all phases of
certain standard for herbal drugs. The purpose is to its cycle. The process of evaluation of the quality and
get recommendations on ways to understand greater purity of crude drugs by means of various parameters
harmonisationin the interpretation and application of like morphological, microscopically, physical,
technical guidelines and requirements for product chemical and biological observations is called
registration thus on reduce or obviate the necessity to standardization. WHO and ICH imported guidelines
duplicate the testing carried outthought out the for the assessment of herbal drugs and medicine. This
analysis and development of latest me I", "C", "H" are approved guidelines by a WHO and ICH for
During exceedingly very manner which embodies the herbal drugs and medicine to discover the quality,
letters in an summary human form. For world efficacy and stability for the betterment used and
harmonization WHO and ICH import specific approved. [2][4]
guidelines for the assessment of the protection,
@ IJTSRD | Unique Paper ID – IJTSRD49571 | Volume – 6 | Issue – 3 | Mar-Apr 2022 Page 549
International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
Objective
Harmonization of legislative & technical requirements.
Mutual acceptance of data between Europe, Japan & US.
To reduce cost of research work duplications.
To reduce time frame for international marketing of newer medicine after approval
To maintain & formulate guidelines on quality, safety & efficacy-based regulations, for client & patient
benefits. [2]
1. Quality Guidelines:
Harmonisation attainment within the Quality category include important milestones like the carrying of stability
studies, determining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical
quality supported Good Manufacturing Practice (GMP) risk management.[8]
S. NO GUIDELINES
Q1A-Q1F Stability:
Q1A: Stability testing of latest and up to date drug substances and products
Q1B: Stability testing: photo stability testing of latest drug substances and products.
Q1C Stability testing for new dosage forms
1
Q1D Bracketing and matrixing designs for stability testing of recent drug substances and
products
Q1E Evaluation of stability data
Q1F Stability data package for registration applications in climatic zones III and IV
Q2 Analytical validation:
2
Validation of analytical procedures
Q3A-Q3D Impurities:
Q3A Impurities in new drug substances
3 Q3B Impurities in new drug products
Q3C Impurities: Guidelines for residual solvents
Q3D Impurities: Guidelines for elemental impunities
Q4A-Q4B Pharmacopeia’s:
4 Q4A: Pharmacopeia Harmonization
Q4B Evaluation and recommendation of pharmacopeial texts to be used within the ICH regions
Q5A-Q5E Quality of biotechnological products:
Q5A Viral safety evaluation of biotechnology products derived from cell lines of human or
5 animal origin
Q5B Analysis of expression construct in cells used for production of r-DNA derived protein
products
Q5C Stability testing of biotechnological/ biological products
Q5D Derivation and characterization of cell substrates used for production of biotechnological/
biological products
Q5E comparability of biotechnological / biological products subject to changes in their
manufacturing process
Q6A-Q6B Specifications:
Q6A Test procedures and acceptance criteria for brand spanking new drug substances and new
6
drug products: Chemical substances
Q6B Test procedures and acceptance criteria for biotechnological/ biological product
7 Q7 Good manufacturing practices for Active pharmaceutical ingredients
8 Q8 Pharmaceutical development
9 Q9 Quality risk management
10 Q10 Pharmaceutical quality system
11 Q11 Development and manufacture of drug substances (Chemical entities and biological entities
2. Safety Gudelines:
ICH has also make a comprehensive set of safety guidelines to reveal and avoid potential risks like
carcinogenicity, reprotoxicity and genotoxicity. [8]
S.NO GUIDELINES
S1A-S1C Carcinogenicity studies:
S1: Rodent carcinogenicity studies for human Pharmaceuticals
1
S1A: Need for carcinogenicity studies of Pharmaceuticals
S1B: Testing for carcinogenicity of Pharmaceuticals
S2 Genotoxicity studies
2 S2 (R1) Guidance on genotoxicity testing and data interpretation for Pharmaceuticals intended to
be use of human
S3A-S3B Toxic kinetics and pharmacokinetics:
S3A note to aware for guidance on Toxicokinetics: The assessment of systemic exposure in
3
toxicity studies
S3B Pharmacokinetics: Guidance for repeated dose tissue distribution studies
S4 Toxicity testing:
4
S4 Duration of chronic testing in animals (Rodent and non-rodent toxicity testing)
S5 Reproductive toxicology:
5
S5 Detection of toxicity to reproduction for medicinal products and toxicity to male fertility
S6 Biotechnological products:
6
S6 Preclinical safety Evaluation of biotechnology derived Pharmaceuticals
S7-S7B Pharmacology studies:
7 S7A Safety pharmacology studies for human Pharmaceuticals
S7B The non-clinical evaluation of the potential for delayed ventricular repolarization by human
Pharmaceuticals
S8 Immunological Studies:
8
S8 Immunotoxicity studies for human Pharmaceuticals
9 S9 Nonclinical evaluation for anti-cancer Pharmaceuticals
10 S10 Photo safety evaluation of Pharmaceuticals
3. Efficacy Guidelines:
Efficacy guidelines are concerned with the planning, carrying, and safety and reporting of clinical trials. It gives
information about biotechnological methods such as novel types of medicines. And therefore the use of
pharmacogenomics techniques to supply better targeted drug. [8][19]
S. No Guideline
1 E1 Clinical safety for drugs employed in long run treatment
2 E2A-E2F Pharmacovigilance
3 E3 Clinical study reports
4 E4 Dose response studies
5 E5 Ethnic factors
6 E6 Good clinical practice
7 E7 Clinical trials in geriatric population
8 E8 General Consideration for clinical trials
9 E9 Statistical principles for clinical trials
10 E10 choice of control group in clinical trials
11 E11 Clinical trials in paediatric population
12 E12 Clinical evaluation by therapeutic category
13 E14 Clinical evaluation
14 E15 Definitions in pharmacogenetics/ Pharmacogenomics
15 E16 Qualification of genomic biomarkers
16 E17 Multi regional clinical trails
17 E18 Genomic sampling methodologies
4. Multidisciplinary Guidelines:
Multidisciplinary Guidelines: Multidisciplinary Guidelines provide information about Common Technical
Document (CTD) medical terminology (MedDRA), and the development of Electronic Standards for the
Transfer of Regulatory Information (ESTRI).[8]
S.NO GUIDELINES
1 M1-MedDRA terminology Medical dictionary for regulatory activities.
2 M2 Electronic standards
3 M3 Non clinical safety studies
4 M4 Common technical document
5 M5 Data elements and standers for drug dictionaries
6 M6 Gene therapy
7 M7 Genotoxic impurities
8 M8 Electronic common technical document (eCTD).
Guidelines: Storage condition

Quality guidelines Stability commitment
1. Q1A-Q1F Stability: The guideline seeks to Evaluation
exemplify the core stability information package Statements
for brand new drug substances and product, but labelling
leaves sufficient flexibility to comprehend the
Drug product
range of various sensible things that will be
The design of the formal stability studies for the drug
encountered thanks to specific scientific concerns
product should be based on knowledge of the
and characteristics of the materials being
behaviour and
evaluated.
Properties of the drug substance and from stability
Drug substances studies on the drug substance and on experience
Information on the stability of the drug substance is
gained from clinical
an important part of the systematic approach to
stability analysis. Formulation studies. The likely changes on storage
and the rationale for the selection of attributes to be
Includes tested in the
Stress testing
Selection of batches Formal stability studies should be stated.
Container closure system Includes
Specification Photo stability testing.
Testing frequency Selection of batches.
Container closure system. Selecting and testing cell lines and other raw
Specification. materials that including media components,
Testing frequency. Undesirable viruses which may be infectious and
Storage conditions. pathogenic for humans;
Stability commitment. Assessing the capacity of the production
Evaluation. processes to clear infectious viruses;
Statements Testing the product at appropriate steps of
Labelling. production for absence of contaminating
2. Q2 Analytical validation: infectious viruses.
The validation of analytical procedures is based on 6. Q6A-Q6B Specifications:
four most common types are The quality of the drug products and drug substances
Identification tests, can be determined by their design, development, in-
Quantitative tests for impurities content, process controls, GMP controls, and process
Limit tests for the control of impurities validation, and by specifications applied to them
Quantitative tests of the active moiety in Samples throughout development and manufacture. This
of drug substance or drug product or other guideline addresses specifications, i.e., those tests,
alternate component in the drug product. procedures, and acceptance criteria which play an
important role in assuring the quality of the new drug
3. Q3A-Q3D Impurities:
substance and new drug product at the release and
This document is meant to provide guidance for
throughout shelf life. Specifications are an important
registration applications on the content and
qualification of impurities in new drug substances component of quality assurance, but it is not only
created by chemical synthesis and not previously Component. All of the considerations mention above
registered in a region or member state. It is not are necessary to ensure consistent production of drug
supposed to use new drug substances used throughout substances and drug products of high quality.
the clinical research stage of development. The 7. Q7 Good manufacturing practice guide for active
following types of drug substances are not covered in pharmaceutical ingredients:
this guideline: biological, biotechnological, peptide, This document is to provide guidance regarding good
oligonucleotide, radiopharmaceutical, fermentation manufacturing practice (GMP) for the manufacturing
product and semi-synthetic products derived there of active pharmaceutical ingredients (APIs) under an
from, herbal products, and crude products of animal appropriate and proper system for managing quality.
or plant origin. 8. Q8 (R2) Pharmaceutical development:
4. Q4A-Q4B Pharmacopoeias: The guideline does not apply to contents of
This document describes a process for the evaluation submissions for drug products during the clinical
and recommendation by the Q4B Expert Working research stages of drug development. However, the
Group (EWG) of selected pharmacopoeia texts to principles in this guideline are important to consider
facilitate their recognition by regulatory authorities during those stages as well. This guideline might also
for use as interchangeable in the ICH regions. be appropriate for other types of products. To
5. Q5A-Q5E Quality of biotechnological products: determine the applicability of this guideline to a
particular type of product, applicants can consult with
This document is concerned with testing and analysis
the appropriate regulatory authorities.
of the viral safety of biotechnology products derived
from characterized cell lines of human or animal 9. Q9 Quality risk management: principles of quality
origin that is example mammalian, avian, insect and risk management are:
outlines data that should be submitted in the The analysis of the risk to quality should be based
marketing application and registration package. The on scientific knowledge and ultimately link to the
purposes of this document to express virus excludes protection of the patient; and
nonconventional transmissible agents like those The level of effort, formality and documentation
associated with Bovine Spongiform Encephalopathy of the quality risk management process should be
(BSE) and scrape. Applicants are focussed to discuss commensurate with the level of risk.
issues associated with BSE with the regulatory
10. Q10 Pharmaceutical quality system:
authorities.
This guideline applies to the systems supporting the
Three principal that are complementary approaches development and manufacture of pharmaceutical drug
have evolved to control the potential viral substances that’s active pharmaceutical ingredients
contamination of biotechnology products: and drug products as well as biotechnology and
biological products, throughout the product lifecycle. To relate the exposure achieved in toxicity studies
The elements of ICH Q10 should be applied in a to pharmacological medicine findings and
manner that is applicable and proportionate to each contribute to the assessment of the relevance of
and every of the product lifecycle stages, recognizing these findings to clinical safety.
the variations among, and also the completely To support the selection of species and treatment
different goals of each stage.
program in non-clinical toxicity studies.
11. Q11 Development and manufacture of drug
To provide information which, in conjunction
substances (chemical entities and
with the toxicity findings, contributes to the
Biotechnological/biological entities):
design of subsequent non-clinical toxicity studies.
A company will prefer to follow completely different
approaches in developing a drug substance. For the 4. S4 Toxicity testing:
aim of this guideline, the terms “traditional” and This guidance has been provided for the development
“enhanced” are used to differentiate two potential of medicinal products with the exception of these
approaches. In a traditional approach, set points and already covered by the ICH Guideline on Safety
operation ranges for method parameters are defined Studies for Biotechnological Products, example:
and the drug substance control and management organism antibodies, Monoclonal antibodies,
strategy is usually based on demonstration of process recombinant DNA proteins.
reproducibility and testing to meet established 5. S5 Reproductive toxicology: This guideline
acceptance criteria.[18] In an associate increase applies to any or all prescription drugs together
approach, risk management and scientific knowledge with biopharmaceuticals, vaccines and their novel
are used more extensively to identify and understand essential ingredients for infectious diseases, and
process parameters and unit operations that impact novel excipients that are part of the ultimate
critical quality attributes and develop appropriate pharmaceutical product. This guideline does not
control strategies applicable over the lifecycle of the apply to cellular therapies, factor therapies and
drug substance which may include the establishment tissue-engineered products. The methodological
of design space. [8][9]. principles is to study design, dose Choice and
Safety guidelines: species selection, etc. outlined in this guideline
1. S1A-S1C Carcinogenicity studies: apply to all compounds for which the conduct of
2. S2 Genotoxicity studies reproductive and developmental toxicity studies is
important. [9]
The objective of this guideline is to outline the
conditions underneath that carcinogenicity studies, 6. S7-S7B Pharmacology studies:
ought to be conducted to avoid the supernumerary use This guideline was developed to help and protect
of animals in testing, and to provide consistency in clinical trial participants and patients receiving
worldwide restrictive assessments of applications. It marketed products from potential adverse effects of
is expected that these studies are performed in a very pharmaceuticals, whereas avoiding excess use of
manner that reflects presently accepted scientific animals and different resources. This guideline
standards [9] This steerage replaces and combines the usually applies to new chemical entities and
ICH S2A and S2B tips the aim of the revision is to biotechnology derived products for human use [7] [8]
optimize the quality genetic materia medica battery Efficacy guidelines:
for prediction of potential human risks, and to supply 1E1-E18: The work and process carried out by ICH
steerage on interpretation of results, The ultimate goal under the Efficacy guidelines is related with the
of rising risk characterization for malignant neoplastic safety reporting of clinical trial and design. It
disease effects that have their basis in changes within additionally covers novel varieties of medicines
the genetic material. The revise internationally agreed derived from biotechnological processes and also the
upon standards for follow-up testing and use of genetics and pharmacogenomics techniques to
interpretation of positive ends up invitto and in vivo produce higher targeted medicines. Clinical studies of
within the customary genetic materia medica battery, medicinal products are conducted to provide
as well as assessment of non-relevant findings [9] information that can improve access to safe and
3. S3A-S3B Toxico kinetics and pharmacokinetics: effective products with appropriate impact on
Objectives: patients, while protecting those participating in the
To describe the general exposure achieved in studies. This guideline provides guidance on the
animals and its relationship to dose level and clinical development lifecycle, that including
therefore the time course of the toxicity study. designing quality into clinical studies, considering the
broad range of clinical study designs and data sources adoption of those international standards essential for
used. [8][6] the direct communication of all information required
in a submission and all associated information
Multidisciplinary Guidelines:
(primarily safety) required as part of the regulatory
IMI-M8: It includes the ICH medical terminology, the
Common Technical Document (CTD) and the process. Harmonisation of the guidance for
nonclinical safety studies will help to explain the
development of Electronic Standards for the Transfer
of Regulatory Information (ESTRI). The objective current recommendations and reduce the likelihood
that substantial differences will exist among regions.
under this guidelines is to define logical electronic
communication standards for communication with [8][6].
Regulatory Authorities. In effect, this means the
A. Botanical Parameters 3. Pass the remaining sample through a sieve no.

1. Sensory evaluation-Visual macros copy, Colour, 250 to remove dust (mineral admixture).
Odour, Taste, Fracture are the common tests
4. Weigh the portion of sorted foreign matter and
conducted for identification of the crude drug [3] determine % w/w of it.
2. Foreign matter-It has to be determined if the 5. If foreign matter resembles plant material, take
foreign matter is
pooled sample and apply physical /chemical test
Organic (Moulds, Insects, Animal waste matter
or microscopy. Determine the proportion of
etc.) or
foreign matter from fail to respond to the test.
Inorganic (Stone, soil etc.).
FOR WHOLE DRUG:
Foreign matter is taken into account as
1. Weigh 100 to 500 g of the sample (or the quantity
Methods to determine the foreign organic matter- specified in the monograph of the drug)
Manual method
2. Spread uniformly the sample on a white tile or a
Procedure: glass plate without overlapping
FOR CRUDE DRUG:
3. Inspect the sample with naked eyes or by means
1. Take weighed quantity of crude drug (500 G
of a lens (3x or above).
root\stem\dark, 250 G leaves flowers\ seed fruit,
50 G cut plant material). 4. Separate the foreign organic matter manually
2. Spread it in a thin layer and sort the foreign 5. After complete separation, weigh the matter and
material by using magnifying lens (10x) or determine % w/w present in the sample
suitable sieve or by visual inspection.
Lycopodium spore method p = number of characteristics particles per mg of the
Lycopodium family is lycopodiaceae species spore of pure foreign matter.
club moss having uniform dimensions (94 m) Wallis (Calculate on the material dried at 105°C).
determined number of spores present in milligram by
94,000 number of spores per mg of Lycopodium
experiments average to be 94000
3. Microscopy test -Identification of histological
Procedure:
characters (under low and high power).
1. Dry the powdered drug at 105°C and determine
its steady weight at room temperature. B. Physicochemical Parameter’s
2. Weigh accurately powdered material and 1. Chromatographic fingerprint-
Lycopodium spores and mix them Proportion of Separation, identification, impurity detection and
2:1 powdered drug to Lycopodium has been assay of herbal drug within the formulation or in
found to be satisfactory. Mix them on a glass extract are carried out by following methods: -
plate with a flexible spatula. HPTLC, HPLC/Densitometry chromatography, GLC,
3. Make a thin smooth paste by adding a suspending TLC test
medium (oil or glycerine: tragacanth mucilage: Importance-The herbal drug shows variability in its
water, 2:1:2) Transfer the paste into a stoppered chemical constituents consistent with various
tube by washing quantity of suspending media. locations/weather. To avoid any erroneous
4. Adjust the final volume by suspending fluid such identification action fingerprint remains the
that about 10 to 20 spores may be present in a assessment of choice.
field of 4 mm objective.
2. Ash value-
5. Oscillate the tube gently to get a uniform The types of ash determined are Total ash, insoluble
suspension.[21] in acid and soluble in water.
6. Place a drop on slide, spread with a needle, put
Ash value is used to determine the quality and purity
coverslip and count the characteristics particles of
of the drug and to establish its identity.
the organic matter as well as the Lycopodium
spores in the field Ash contains inorganic radicals lie phosphates,
7. Make one more slide in the same way and count carbonates, and silicates of sodium, potassium,
25 fields magnesium, calcium etc. These are present in definite
amount during a particular crude drug, hence
8. Prepare another suspension as described above,
quantitative determination in terms of varied ash
prepare two more slides and count 25 fields each
values helps in their standardization. Ash value is
for both preparations as above.
used to determine foreign inorganic impurity. [3]
9. Determine the average of 4 sets of counts (4 x 25
= 100 fields in all).and also the percentage of Total Ash Value-The method of total ash is meant to
moisture present from the first step. Calculate the determine the amount of material that remains after
number of characteristics particles present in one ignition. Ash is assessed as physiological ash which is
mg of the powder dried at 105°C Determine in a derived from the plant part itself and non-
similar way the number of characteristic particles physiological ash which is that the residue after
per mg of the pure foreign matter, calculated with ignition of extraneous matter (e.g. sand and soil).It is
reference to the material dried at 105° (If this carried out at low temperatures possibly because
number can be obtained from the literature a alkali chlorides, which a volatile at low temperatures,
special experiment is unnecessary). may be lost. The total ash consists may be carbonates,
phosphates, silicates and silica.
Calculate the percentage of foreign organic matter
from the formula Acid insoluble ash- Inorganic variables like calcium
oxalate, silica, and carbonate content of the crude
Percentage of foreign organic matter drug affects Total cash value. Acid soluble ash is
determined by removed variables by treating with
acid if its soluble in hydrochloride acid Same as the
Where, Acid insoluble Ash, Water soluble ash and sulphated
n = number of characteristics particles in 25 fields. ash are also evaluated
s = number of spores in the same 25 fields
3. Extractive values
w = weight in mg of Lycopodium taken.
Its useful for evaluation of a crude drug. It gives a
m = weight in mg of the sample (calculated on the
sample dried at 105°C). thought about the nature of the chemical
constituents present in crude drug. Useful for C. C-the volume of quinine hydrochloride R (in mg)
constituents extracted with the solvent used for in the tube with the threshold bitter concentration.
extraction. Employed for material that far no 2. Haemolytic property-
suitable chemical or biological assay exists. It are
Many medicinal plant materials, of the families
often done by following methods: Caryophylaceae, Sapindaceae, and Dioscoreaceae
• Cold maceration, contain saponins.
• Hot extraction
The main property of saponins is their ability to
4. Moisture content and volatile matter test - cause haemolysis
The Drug moisture content should be minimized to
prevent decomposition of crude drug either due to Formula: 1000× a
chemical change or microbial contamination. b
The moisture content is decided by heating a drug at Where,
105˚c in an oven to a constant weight. 1000-the defined haemolytic activity of saponin R in
relation to ox blood
E.g. – Aloe should have moisture content not more
A. quantity saponin R that produces total haemolysis
than 10% w/w Moisture
(g)
Content can be determined by following methods - B. quantity of plant material that produces total
Gravimetric haemolysis (g)
Volumetric
3. Astringent property-
instrumental
It is determined by amount of tannins present in
Gravimetric method-Loss on Drying, the drug Tannins (or tanning substances) are
Volumetric-Azeotropic Toluene distillation method, substances capable of turning animal hides into
leather by binding proteins to form water
Instrumental- GC, NMR etc. insoluble substances that are resistant to
Volatile oil content- Essential oils are the liquid proteolytic enzymes. This process, when applied
components of the plant cells, immiscible with water, to living tissue, is called as an "astringent" action.
volatile at ordinary temperature and may be steam tannins is mixtures of polyphenols that are
distilled at ordinary pressure. Many herbal drugs difficult to separate and crystallize complex in
contain Essential oil which is employed as flavouring nature [14]
agent.
4. Swelling Index-
For the drugs containing volatile constituents, toluene The swelling index is the volume occupied by 1
distillation method/steam distillation method is used gram of swollen material
to determine the volatile oil contents. Its determination is based on the addition of water
C. Pharmacological Parameter’s or a swelling agent as shown in the test procedure
1. Bitterness value- for each individual plant material (either whole,
Medicinal plants having strong bitter taste are cut or pulverized).
therapeutically used as appetizing agents .The It gives an idea content of the drug i.e. mucilage
bitterness is determined by comparing the [12]
threshold bitter concentration of an extract 5. Foaming agent-
material with that of quinine hydrochloride.[11] Procedure:
The bitterness value unit is equivalent to the Take 1g of coarse powder of the plant material in
bitterness of a solution containing 1gm of quinine a 500 ml conical flask
hydrochloride in 2000ml Water. Add 100 ml of boiling water and maintain
moderate boiling for the 30 minutes.
Formula- Bitterness value in unit pee gm. = 2000×C Cool and filter
A×B Collect the filtrate decoction in a 100 ml
volumetric flask and make up the volume is
Where,
100ml
A. the concentration of the stock test solution (S.)
Pour the decoction into 10 stoppered test tubes
(Mg/ml).
(height 16 cm, diameter 16 mm) as 1 ml, 2 ml, 3
B. the volume of test solution S, (in ml) in the tube ml, etc. up to 10 ml.
with the threshold bitter concentration, 10 ml by adding quantity of water and stopper the
tubes.
Shake test tubes for 15 seconds (two shakes per Conclusion:
second). Harmonization achievements within the quality space
Stand for 15 minutes test tube and calculate the embody important milestones like the conduct of
height of the foam. stability studies, process relevant thresholds for
impurities testing and a lot of versatile approach to
D. Toxicological Parameters
pharmaceutical quality supported smart producing
1. Arsenic: Stain produced on HgBr paper in
apply (GMP) risk management in herbal product. The
comparison to standard stain.
WHO guidelines are followed all over the world but
2. Pesticide residues: Includes total organic chloride the need of the hour is to update these principles with
and total organic phosphorus. application of newer methods of analysis. The
3. Heavy metals: Like cadmium and lead. Guidelines Review Committee make sure that WHO
tips are of a high method quality and are developed
4. Microbial contamination: Total viable aerobic through a clear, evidence-based decision-making
count of pathogens: Salmonella, P. aeruginosa method. The herbal drug assessment in Ayurveda is
and S. aureous.[20] about the whole drug rather than concentrating on the
5. Aflatoxins: By TLC using standard aflatoxins active principles or phytoconstituents, thus finer
(B₁, B₂, G₁ and G₂). methods of standardization should be developed.
Herbal drug a rigorous quality assurance method that
6. Radioactive contamination. helps to confirm and each printed guideline is
Arsenic or other any heavy metal is contaminated trustworthy, impactful and meets the best
with medicinal plant then cause many serious international standards. As Ayurvedic drugs are also
effect such as environmental pollution and traces included in the Drugs and Cosmetics Act, 1940 the
of pesticides. Arsenic, Lead, cadmium is drugs have to be safe and effective.
identified by the limit test or it by the lead and Acknowledgement
cadmium may be determined by the inverse in We would like to express our sincere gratitude
voluntary or by the atomic emission towards project guide & friends, who gave us the
spectrophotometry.[12] appropriate guidance and encouraged us to carry out
The maximum amount of metal present in work on this review article
medicinal plant is References
Lead contains 10mg/kg [1] Introduction to the ICH [2014] from:
Cadmium contains 0.3mg/kg www.ich.org/fileadmin/Public
Determination of pesticide Web...ICH/.../Iintroduction_to_ICH.pdf
Residue it is does not contain more than 1% [2] WHO_WORLD_HEALTH_ORGANIZATION
Pesticides per kg of plant material i.e. (ARL) is _GUIDELINES_FOR_STANDARDIZATION
calculated by the maximum acceptable daily intake of _OF_HERBAL_DRUGS
the pesticides for human that i.e. (ADI) as [3] KR Khandelwal, [2013] Practical
recommended WHO and means daily intake i.e. Pharmacognosy, 2nded, Nirali Prakashan,
(MDI) of the medicinal plant material Pune, 23.1-23.4.
ARL= ADI×E×60 [4] Quality assessment of herbal preparations as
MDI×100 precondition of pharmacological and clinical
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WHO & ICH Guidelines for the Assessment of Herbal Drug

ABSTRACT How to cite this paper: Ms. Bhadane

Guidelines: Storage condition

A. Botanical Parameters 3. Pass the remaining sample through a sieve no.

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