Discuss various aspects of Quality Control and Standardisation of Ayurvedic drugs.

1. STANDARDISATION AND QUALITY
CONTROL OF AYURVEDIC DRUGS
Dr. Ravindra Singh
Assistant Director (Chem.)
Central Council For Research in Ayurvedic Sciences, New Delhi-110058
Email- ravindrasinghm@gmail.com

2. According to WHO 80% of world’s population still relies on traditional
system of medicines for primary healthcare.
25% of total drugs in modern pharmacopoeias are plant based and many
are based on synthetic analogues isolated from plants.
Plants can be considered as chemical factories that have been evolving
their biosynthetic pathways for 4,00,000 million years. The array of
compounds synthesized by them is beyond the imagination of today’s
chemists .

3. •Rely almost 90% on the use of Medicinal plants alone and/or
supplemented with minerals, metals, animals and marine resource.
•95% of the medicinal plants used by ASU drug manufacturers are
procured from wild sources.
•Quality control of the raw material, process of manufacture and
finished product constitute wholesome quality of ASU Drugs.
Ayurveda, Siddha & Unani Drugs

4. India -
• Have 16 Agro-climatic zones.
• Have 2 biodiversity hot spots.
•Have 7 % of world biodiversity.
•48,000 plant species exist (i.e. 11 % of known
plant species of the world).
•9000 species used in ISM & Folk medicines.
•9000 – ISM Manufacturing Units

5. Raw materials employed in Ayurveda & Siddha
System
Whole plant Eclipta alba
Rhizome Z.officinale
Fruit C.aurantifolia
Stamen C.sativus
Seed -P..pinnata
Stem bark -C.zeylanica
Leaves
C..alata
Flower V.negundo

6. Metal
Mineral
Animal Origin

8. Legal Definitions of Ayurvedic Drugs
under Drugs & Cosmetics Act, 1940
 Classical/Shastriye/Traditional:
Rule 3A : Ayurvedic, Siddha or Unani drug includes all medicines intended
for internal or external use for or in the diagnosis, treatment, mitigation
or prevention of disease or disorder in human beings or animals, and
manufactured exclusively in accordance with the formulae described in
the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of
medicine, specified in the Schedule I of the Act.
i.e such formulations as are described in 103 authoritative
books including pharmacopoeias and formularies.

9. AYURVEDIC DRUG
 Rule 3[(h)] Patent or Proprietary medicine means,—
(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all
formulations containing only such ingredients mentioned in the
formulae described in the authoritative books of Ayurveda, Siddha or
Unani Tibb systems of medicine specified in the First Schedule, but
does not include a medicine which is administered by parenteral route
and also a formulation included in the authoritative books as specified
in clause (a);

10. How Ayurvedic Drugs are regulated in
India
 Ayurvedic Drugs are regulated in India by Drugs & Cosmetics
Act, 1940 and Rules, 1945.
 Chapter IV A (included in 1964) describes the various provisions
for ASU drugs.
 Regulations are in place for licensing, QC, Quality Management
(Schedule T & T1), Manufacturing, labeling etc.

11. Quality Control & Safety Aspects of Drugs
•Standards of identity, purity and quality prescribed in ASU
Pharmacopoeias.
•Licensing must for commercial manufacturing of drugs with compliance
to GMP, separate GMP provisions for Herbo-metallic drugs.
•Onus of safety and quality vested with the drug manufacturers (Rule
168).
•Safety monitoring of ASU drugs under National Pharmaco-vigilance
Programme.

12. DIFFERENT DOSAGE FORMS IN
AYURVEDA
Solid Semi Solid Liquid
Churna Avaleha Asava Arista
Kwath Churna Kalka Arka
Rasa Yog Lepa Swarasa
Bhasma Malhara (ointment) Khashaya (Kwath)
Ghan Vati Phanta (Hot infusion)
Vati Hima (Cold infusion)
Varti Netra Bindu (Eye Drops)
Guggulu
Sattva (Extract)
Lavana
Kshara

13. RULE 160. Identification of raw materials—Raw materials used in the preparation of Ayurvedic
(including Siddha) or Unani drugs shall be identified and tested, wherever test are available for their
genuineness, and records of such tests as are carried out for the purpose and the methods thereof
shall be maintained.
PART XIX
STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS
RULE 168. Standards to be complied with in manufacture for sale or for distribution of
Ayurvedic, Siddha and Unani Drugs.-
Sl. No. Class of Drugs Standards to be complied with
1.
2.
Single drugs included in
Ayurvedic Pharmacopoeia.
Asavas and Aristas
The standards for identity, purity and
strength as given in the editions of
Ayurvedic Pharmacopoeia of India for the
time being in force.
The upper limit of alcohol as self generated
alcohol should not exceed 12% v/v excepting those
that are otherwise notified by the Central govt. from
time to time.

14. As per Schedule T
The manufacturer should ensure that:
•Raw materials used in the manufacturing of drugs are authentic, of prescribed
quantity and are free from contamination;
•The manufacturing process has been prescribed to maintain the standards;
•Adequate quality control measures are adopted;
•The manufactured drug which is released for sale is of acceptable quality;
•To achieve the objectives above, each licensee shall evolve methodology and
procedures for following the prescribed process of manufacture of drugs which
should be documented as a manual and kept for reference and inspection.

15. Leaves
Roots
Whole Plant
Wood
Rhizomes
Bark
Stem
Flowers
Fruits
Seeds
Breakup by parts used of Medicinal Plants
Leaves 6%
Whole Plant 16%
Wood 3%
Rhizome 4%
Bark 14%
Stem 6%
Flowers 10%
Fruits 7%
Seeds 4%
Roots 30%

16. Challenges before us:
Raw Material: 90-95 percent of raw material used in manufacturing of ASU medicines are
procured from wild and its quality is not known.
No information about place (geographical location) and date of collection.
No information about the conditions of storage, after collection and in transit.
No information about maturity of the raw material.
Adulteration of raw material - willingly or unwillingly.

17. THE THREE PILLARS OF IDEAL ASU&H DRUGS AND
THEIR RATIONAL USE ARE :
Out of which quality is to be built into the final product starting from the raw material to the
finished product.
Safety means that the drug should be free from significant or unreasonable risk of adverse
reactions and the product must have toxicity clearance unless traditionally used for long
periods without side effects.
Efficacy of a drug is measured by its clinical evaluation.
Quality
Safety Efficacy

18. QUALITY of
ASU Drugs
Adherence to Good
Agricultural Practices,
Good Collection Practices
Good Storage
Practices
Good Manufacturing Practices
Setting Specifications by
Drug Control Authorities
Quality control
throughout production
Factors contributing to Quality of ASU&H Drugs

19. IDENTITY OF RAW MATERIAL ADULTERATION & SUBSTITUTION
Adulteration & Substitution - Admixture of Genuine article with spurious, inferior, useless substitutes
INTENTIONAL UNINTENTIONAL
Common Vernacular Names
Same Plant with Different Vernacular
Name
Unscrupulous when drug is scarce or costly
Different but similar looking material
* Ashoka
* Kutaja
Exhausted products
* Cloves
* Cardamom
With similar looking other plants
* Chiriata
* Ratanjot
* Black pepper, Papaya
Partial adulteration with similar looking substances
* Saffron
Imitation material
* Clay
SCIENTIFIC VALIDATION
PROBLEMS IN HERBAL MEDICINES

20. Major Causes of inconsistency in Herbal
Drugs
 REGIONAL/LINGUISTIC NOMENCLATURE
 ECOTYPIC, GENOTYPIC, CHEMOTYPIC VARIATIONS.
 HARVESTING PERIOD
 METHOD OF DRYING
 STORAGE CONDITIONS
 MODE OF GRINDING AND PARTICLE SIZE
 EXTRACTION PROCEDURE
 NATURE OF FORMULATION
 SHELF LIFE

21. NEED of Drug Standardisation:
•Plants growing in different Geographical locations and varied
climatic conditions.
•The phytoconstituents may vary.
•Genetic variants are also encountered.
•The collection may not be as per Good Collection Practices.
•The drug may be adulterated willingly or unwillingly.
•Plant may contain hundred to thousand of Phytochemicals.
•Developing Uniform standards may not be easy to cover all the
plants growing in all the possible geographical zones.

22. Quality is the guarantee of a product for its acceptability to
consumers and regulatory authorities.
Quality can be defined as the “Sum total of all factors which
contribute directly or indirectly to the safety, effectiveness
and acceptability of the product”
QUALITY

23. Quality control of the raw material, process of manufacture and finished
product constitute wholesome quality of ASU Drugs.
Quality Control is an operation undertaken in a laboratory to analyze a sample or material
within the known probability limits of accuracy and precession.
while
Quality Assurance is defined as system through which laboratory conducts the
analysis , the proof of which lies in documentation .
Quality assurance also requires to control of starting materials, storage and processing.
For this reason , an appropriate quality assurance system should be applied in
the manufacture of herbal medicines.

24. Quality Assurance (QA) of herbal medicinal products is the shared
responsibility of Manufacturers and Regulatory Authorities.
National Drug Regulatory Authorities have to establish guidelines on all
elements of QA.
The Manufacturers have to adhere to Good Agricultural and Collection
Practices (GACP), GMP and Good Laboratory Practices (GLP) standards,
establish appropriate specification for their products, intermediates and
starting materials and compile a well-structured, comprehensive documentation
on pharmaceutical development and testing.

25. ELEMENTS OF QUALITY ASSURANCE
Adherence to GACP, GMP and GLP guidelines
Control of raw material
Control of starting materials and intermediate substances
In-process control (SOP’s should be mentioned)
Finished products control
Setting Specifications
Quality Control Measures
The purpose of QC is to ensure quality of the products by adhering to
appropriate specification and standards. Information on appropriate
standards can be found in official pharmacopoeias.

26. ELEMENTS OF QUALITY ASSURANCE
Adherence to GACP, GMP and GLP guidelines
Control of raw material
Control of starting materials and intermediate
substances
In-process control (SOP’s should be mentioned)
Finished products control
Setting Specifications
Quality Control Measures
The purpose of QC is to ensure quality of the products by adhering to
appropriate specification and standards. Information on appropriate standards
can be found in official pharmacopoeias.

27. 2
Quality
Rational Drug
Efficacy
Safety
Quality is the Basis of Reproducible Efficacy and
Safety

28. QUALITY STANDARDS
The Quality Standards of ASU drugs can be
broadly classified into:
Identity
Strength Purity

29. IDENTITY
 Botanical Identity
 Macroscopy
 Microscopy
 Colour test
 Fluorescence test
 Chromatographic test
Size,Colour,Shape,
Odour, Surface markings,
Internal appearance, Cut
surfaces, Fracture, Taste
(Caution necessary).

30. IDENTITY
Microscopy
Qualitative
Types of crystals
Types of stomata
Distribution and type of
trichomes
Starch grains
Powder Microscopy
Quantitative
Palisade ratio
Stomatal Index
Vein-Islet number
Veinlet termination
number

31. d
Pharmacognosy
starch grain
cork cells associated with
sclereids
Prismatic crystals of calcium oxalate
groups of sclereids with idioblast crystals
cells filled with reddish brown content
crystal fibres
fibre
sclereids
tangentially cut medullary ray
cork cells in
surface view
radially longitudinally cut medullary ray
cork in sectional view
Powder Microscopy of Shorea robusta Gaertn.

32. Purity
 Foreign matter
 Total Ash
 Acid insoluble ash
 Loss on Drying
• Extractive values
• Estimation of marker
compounds
• TLC/HPTLC with marker
chemicals
Strength
•Microbial load
•Pesticide residue
•Heavy metals
•Aflatoxins
•Toxicity Studies (acute, sub-acute, chronic)
•Pharmacology
Anti-fertility, hepatoprotective, anti-
inflammatory, anti-oxidant etc.
Safety and Efficacy

33. HERBAL DRUGS
STANDARDIZATION
THE STANDARDIZATION OF HERBAL DRUG AND A
PREPARATION THEREOF IS NOT JUST AN A
NALYTICAL OPERATION: IT DOES NOT END WITH
THE IDENTIFICATION AND ASSAY OF AN ACTIVE
PRINCIPLE, RATHER IT EMBODIES TOTAL INFORMATION
AND COTROLS THAT ARE NECESSARY TO
GUARANTEE CONSISTENCY OF COMPOSITION.

34. STANDARDIZATION
OF PLANT DRUGS
Authentication
Microbial Count
Pesticide
Residue
Marker
Component
Chromatographic Profile
Extractive Value
Ash Value
Volatile Matter
Macroscopy &
Microscopy
Organoleptic
Evaluation
Foreign Matter
Authentication and Standardization of
Herbal Raw Material

35. Parameter Specifications
Total Bacterial Count 1x105 CFU/gm
Total Fungal Count 1x103 CFU/gm
E. coli, Salmonella, P. aeruginosa, S. aureus Absent
Pesticide Residue (Organo-chloro group) Less than 1 ppm
Heavy Metals
Lead 10 ppm
Mercury 1 ppm
Arsenic 3 ppm
Cadmium 0.3 ppm
Aflatoxins B1 &G1- 0.5, B2 &G2- 0.1 ppb

36. LIMITS FOR HEAVY METALS IN VARIOUS COUNTRIES
Country Arsenic Lead Cadmium Chromium Mercury
Canada Raw Drugs 5ppm 10ppm 0.3ppm 2ppm 0.2ppm
Finished
Products
0.01mg/da
y
0.02mg/day 0.006mg/day 0.02mg/day 0.02mg/day
China Raw drugs 2ppm 10ppm 1ppm - 0.5ppm
Malaysia Finished
Products
5mg/kg 10mg/kg - - 0.5mg/kg
Singapore Finished
Products
5mg/kg 20ppm - - 0.5ppm
Thailand Raw
drugs/finishe
d prod.
4ppm 10ppm 0.3ppm - -
WHO
Recommendatio
ns
Herbal
material,
finished
herbal
products
- 10mg/kg 0.3mg/kg - -

39. AYURVEDIC PHARMACOPOEIA OF INDIA Part II
(Compound Formulations)

40. THANK You