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Introduction

India has Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules of 1945 for drug regulation. Also Dangerous Drug Act, 1930 and Poisons Act 1919 define drug related policies. These acts and related rules regulate export, manufacture, distribution and sale of drugs and cosmetics.

Considering increase in demand, use and export of drugs from Ayurvedic and other systems included in AYUSH; Government of India has specified the rules and notifications related manufacturing, standardization and other aspects of drug usage. Ayurvedic, Unani and Homoeopathic Pharmacopoeias published by the Govt. of India have prescribed various standards to be followed for ISM & Homoeopathic drugs.

In 2002 Govt. of India published Good Laboratory Practices (GLP) guidelines to guide the drug analysts in maintaining high scientific and professional standards for ensuring only drugs of the highest quality are produced and marketed. In 2003, government issued notification of Good Manufacturing Practices (GMP) to ensure authentic, contamination free quality raw material, manufacturing process and product with desired quality standards.

Guidelines for Quality Control

Standards for quality control are based on pharmacognostic, physicochemical, phytochemical and biological parameters. General process and parameters employed in present standardization of herbal drugs is described below.

  • Sample collection as per suitable sampling plan
  • Identification
  1. Organoleptic characterization
  2. Specific chemical tests (wherever available)
  3. Microscopic analysis
  4. Powder microscopy
  5. TLC comparison with authentic reference standard
  • Physico-chemical Analysis
  1. Moisture content
  2. Volatile / fixed oil determination
  3. Ash value (total, sulphated, acid insoluble, ash etc)
  4. pH of 5 % w/v suspension
  5. Extractive values (with various solvents like alcohol, water etc)
  6. Identity tests (like T.L.C., HPLC etc)
  • Phytochemical analysis
  1. Quantification of bioactive/marker compounds
  2. Quantification of characteristic category compounds (like flavanoids, alkaloids, terpenoids, glycosides etc)
  • Microbiological analysis
  1. Total viable aerobic court
  2. Total enterobacteriaceae
  3. Total fungal count
  4. Test of specific pathogens (S. aurus, E. coli, P. aeruginosa etc)
  • Residual analysis
  1. Foreign matter
  2. Heavy metals residues (Pb, Cd, Hg, As etc)
  3. Pesticide residues (organochloro, organophosperous etc)
  4. Mycotoxin residues (Aflatoxins B1, b2, G1, G2, Sterigatocistin, Ochratoxin etc)
  5. Radioactive residues
  6. Solvent residues (volatile organic impurities)
  • Biological activities
  1. Dose response curve
  2. Dose and duration
  3. Limits of desired bioactivity
  • Toxicity or Safety profile
  1. Acute toxicity (including LD 50 value)
  2. Sub-acute toxicity
  • Other documentation
  1. Rasa (Taste), Veerya (Predominant action), Vipaka (Metabolic action)
  2. Guna (Properties), Karma (Pharmacological action)
  3. Authentic/Textual References
  4. Important Formulations, Dose etc.
  5. Therapeutic Uses
  • Processing specifications
  1. Details of manufacturing process
  2. Bhaavanaa, Mardana, Put`a etc
  3. Shelf life, storage

Standards for classical dosage forms

Each dosage form (Kalpanaa) has specific manufacturing process hence requires separate standards for assessment of quality and purity. Considering nature of raw materials, processing and product; each formulation type has to be screened for various parameters like contamination (e.g. microorganisms), assessment of expected level of desired ingredients (e.g. Sugar) or results of manufacturing processes (e.g. extractive value after extraction).

Standards for some of the classical dosage forms are described based on compilation of various guidelines. Users are advised to go through references and follow respective norms after proper scrutiny of local guidelines and legal considerations. (e.g. Each state or province might have different act, rules also different lists of banned drugs etc.)

Protocol of testing Kvaatha (Decoction)

  1. Name of preparation
  2. Reference
  3. Organoleptic Characters (Colour /Odour etc)
  4. pH
  5. Total solids
  6. Specific Gravity
  7. Test for heavy/toxic metals
    a.    Lead
    b.   Cadmium
    c.    Test for Arsenic
    d.   Mercury
  8. Microbial Contamination |
    a. Total viable aerobic count
    b. Enterobacterciaceae
    c. Total fungal count
  9. Test for specific Pathogens
    a.    E. Coli
    b.   Salmonella Spp.
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  10. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  11. TLC/HPTLC- with marker (wherever possible)
  12. Pesticide residue
    a.    Organochlorine pesticides
    b.   Organophosphorous pesticides
    c.    Pyrethroids
  13. Dosage
  14. Shelf life
    a.  Normal
    b.  ccelerated

Protocol of testing Avaleha (Leha and Paaka)

  1. Name of preparation
  2. Reference
  3. Description:
    a.    Macroscopic
    b.    Microscopic
  4. Colour
  5. Odour
  6. Taste
  7. Consistency
  8. Total sugar
  9. Reducing sugar
  10. TLC/HPTLC
  11. Extractive value
    a.    Hexane voluble
    b.   Alcohol soluble
    c.    Water soluble
  12. Fat content
  13. Loss on drying at 105C
  14. Total solid content
  15. pH
  16. Specific gravity at 25C
  17. Ash value:
    a.    Total ash value
    b.   Acid insoluble ash
    c.    Sulphated ash
  18. Assay of main ingredients
  19. Crude fibre content (in case of Prakshepa Dravya)
  20. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  21. Microbial contamination.
    a. Total Bacterial count
    b. Total fungal count
    c. Enterobacterciaceae
    d. Salmonella Spp.
  22. Ayurvedic specification
    a. Supakvam
    b. Tantumatatvam
    c. Apsumajati
    d. Karatvam Pidite mudra
    e. Gandha Varn`a Rasaodbhavam
  23. Therapeutic indications
  24. Dose
  25. Shelf life
    a.    Normal
    b.    Accelerated

Protocol of testing Taila / Ghrita

  1. Name of preparation
  2. Reference
  3. Description
  4. Colour (RYB value)
  5. Odour
  6. Rancidity
  7. Coagulation point
  8. Specific gravity (wt. /ml.) at room temperature
  9. Refractive index at 25C
  10. Viscosity
  11. Specific tests
    a.    Saponification value
    b.   Acid value
    c.    Iodine value
    d.   Peroxide value (residue)
    e.    Free Fatty acids
    f.     Qualitative test (For particular oil)
    g.   Total fatty matter
  12. Test for mineral oil (ISI method)
  13. TLC /HPTLC Profile of unsaponifiable matter
    a.    Assay for main ingredients
  14. Therapeutic use
  15. Dosage
  16. Congealing point (for Ghrita only)
  17. Shelf Life study
    a.    Normal
    b.   Accelerated.

Protocol of testing Guggulu (Guggulu based formulations)

  1. Name of preparation:
  2. Reference
  3. Description
    a.    Identification
    b.   Macroscopic
    c.    Microscopic
    d.   Uniformity by weight
  4. pH
  5. Extractives
    a.    Alcohol soluble extract
    b.   Water extract
  6. Loss on drying on 105C
  7. TLC
  8. Ash value:
    a.    Total ash
    b.   Acid insoluble ash
  9. Description: general, including colour, odour, taste etc
  10. Volatile oil contents (Oleo gum resin)
  11. Test for resin
  12. Assay for main ingredients
  13. Disintegration time
  14. Metal compound contents (as per Bhasma if added)
  15. Test for heavy metals
    a.    Lead
    b.    Cadmium
    c.     Arsenic
    d.    Mercury
  16. Microbial contamination
    a.    Total viable aerobic count
    b.   Enterobacteriaceae
    c.    Total fungal count
  17. Test for specific pathogen
    a.    E. coli
    b.   Salmonella spp
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  18. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  19. Pesticide residue
    a.    Organochlorine pesticides
    b.   Organophosphorus pesticides
    c.    Pyrethroids
  20. Therapeutic indications
  21. Dose
  22. Shelf Life study
    a.    Normal
    b.   Accelerated.

Protocol of testing Bhasma

  1. Name of preparation
  2. Reference
  3. Method of preparation
    a.    Method of सौषधं (purification) with reference
    b.   Method of Bhasma formation with reference
    c.    Types & No. of Put`a (Incunation)
    d.   Bhavana Dravya Used (Trituration material used)
  4. Description (colour & texture)
  5. Particle size
  6. Loss on drying
  7. Acid insoluble ash
  8. Water solubility
  9. Organoleptic characters: general, including colour, odour, taste etc
  10. Heavy metal test
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  11. Assay (of main ingredients)
  12. Namburi Spot Test
  13. Ayurvedic specifications
    a.    Lusterless (Nis`hchandrikaa)
    b.   Fineness (fine enough to enter in lines of finger – Rekhaapoorn`atva)
    c.    Floats on water (Vaaritara)
    d.   Smokeless (Nirdhooma)
    e.    Tasteless (Nisvaadu)
    f.     Irreversible (Apunarbhava)
  14. Dose
  15. Method of administration
  16. Toxicity report
  17. Shelf Life study
    a.    Normal
    b.   Accelerated.

(In the final product Bhasma, metals are the compounds forms which are not toxic.)

Protocol of testing Vat`i / Gut`ikaa (pills & tablets)

  1. Name of preparation:
  2. Reference
  3. Description
  4. Physical characteristics
    a.    Colour
    b.   Odour
    c.    Taste
    d.   Macroscopic characteristics
    e.    Microscopic characteristics
    f.     Texture
    g.   Size
  5. TLC, HPTLC profile
  6. Loss on drying at 110 0 C
  7. Ash value:
    a.    Total ash
    b.   Acid insoluble ash
    c.    Sulphated ash
  8. Study of extractives
    a.    Alcohol soluble extracts
    b.   Water soluble extracts
  9. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  10. Microbial contamination
    a.    Total viable aerobic count
    b.   Enterobacteriaceae
    c.    Total fungal count
  11. Test for specific pathogen
    a.    E. coli
    b.   Salmonella spp
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  12. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  13. Pesticide residue
    a.    Organochlorine pesticides
    b.   Organophosphorus pesticides
    c.    Pyrethroids
  14. Shelf life study
    a.    Normal
    b.   Accelerated
  15. Average weight
  16. Disintegration time
  17. Hardness
  18. Friability
  19. Content uniformity
  20. Metal content
  21. Weight variation
  22. Usual dose
  23. Therapeutic indications

Protocol of testing Lauha / Man`d`oora (Preparations of iron prominence)

  1. Name of preparation
  2. Reference
  3. Description
  4. Physical characteristics
    a.    Macroscopic characteristics
    b.   Microscopic characteristics
  5. Particle size
  6. Loss on drying at 105 0 C
  7. Ash value:
    a.    Total ash
    b.   Acid insoluble ash
  8. Study of extractives
    a.    Alcohol soluble extracts
    b.   Water soluble extracts
  9. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  10. Microbial contamination
    a.    Total viable aerobic count
    b.   Enterobacteriaceae
    c.    Total fungal count
  11. Test for specific pathogen
    a.    E. coli
    b.   Salmonella spp
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  12. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  13. TLC, HPTLC profile
  14. Ayurvedic specifications
    a.    Lusterless (Nis`hchandrikaa)
    b.   Fineness (fine enough to enter in lines of finger – Rekhaapoorn`atva)
    c.    Floats on water (Vaaritara)
    d.   Smokeless (Nirdhooma)
    e.    Tasteless (Nisvaadu)
    f.     Irreversible (Apunarbhava)
  15. Shelf life study
    a.    Normal
    b.   Accelerated

Protocol of testing Kshaara / Lavan`a (compounds of salts)

  1. Name of preparation
  2. Reference
  3. Description
    a.    Colour
    b.   Odour
    c.    Taste
    d.   Texture
  4. Identification: chemical test applicable to identify major
  5. Loss on drying at 105 0 C
  6. pH
  7. Acid insoluble ash
  8. Solubility in water
  9. Assay for specific salt
  10. Therapeutic indications
  11. Dose and method of administration

Protocol of testing Choorn`a (powders)

  1. Name of preparation
  2. Reference
  3. Description
  4. Particle size
  5. Identification:
    a.    Macroscopic
    b.   Microscopic
    c.    Phyto-chemical tests assay wherever possible
    d.   TLC
  6. Study of extractives
    a.    Hexane soluble extracts
    b.   Alcohol soluble extracts
    c.    Water soluble extracts
  7. pH
  8. Loss on drying at 105 degree C.
  9. Ash value
    a.    Total ash
    b.   Acid insoluble ash
  10. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  11. Microbial contamination
    a.    Total viable aerobic count
    b.   Enterobacteriaceae
    c.    Total fungal count
  12. Test for specific pathogen
    a.    E. coli
    b.   Salmonella spp
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  13. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  14. TLC / HPTLC with marker
  15. Pesticide residue
    a.    Organochlorine pesticides
    b.   Organophosphorus pesticides
    c.    Pyrethroids
  16. Therapeutic indication (Ref. to AFI)
  17. Method of application to be specified.
  18. Shelf life study
    a.    Normal
    b.   Accelerated

Protocol of testing Aasava / Aristha

  1. Name of preparation:
  2. Reference
  3. Description
    a.    Macroscopic
    b.   Microscopic
  4. Colour (RYB Value)
  5. Odour
  6. pH
  7. Specific Gravity at 25º C
  8. Total Solids
  9. Alcohol Contents
  10. Non reducing sugars
  11. Reducing sugars
  12. TLC/HPTLC
  13. Test for methanol
  14. Total acidity
  15. Safety profile
  16. Test for heavy metals
    a. Lead
    b. Cadmium
    c. Arsenic
    d. Mercury
  17. Dosage
  18. Shelf life study
    a.    Normal
    b.   Accelerated

Protocol of testing Arka

  1. Name of preparation:
  2. Reference
  3. Description
  4. Colour
  5. Odour
  6. pH
  7. Volatile Matter
  8. Specific Gravity at 25º C
  9. Clarity Test /Suspended Particles
  10. Sterility Test
  11. Assay
  12. TLC /HPTLC/GLC
  13. Dosage
  14. Shelf Life study
    a.    Normal
    b.   Accelerated
  15. Microbial contamination

Protocol of testing Parpat`ee

  1. Name of preparation
  2. Reference
  3. Colour
  4. Touch
  5. Particle size
  6. Lusterless (Nis`hchandrikaa)
  7. Loss on drying at 105 º C
  8. Assay of Mercury and Sulphur
  9. Dosage
  10. Shelf Life study
    a.    Normal
    b.   Accelerated

Protocol of testing Kupipakva Rasaayana (Mercurial compounds)

  1. Name of preparation
  2. Reference
  3. Organoleptic characters (Colour, taste etc)
  4. Ash value:
    a.    Total ash
    b.   Acid insoluble ash
  5. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  6. Microbial contamination
    a.    Total viable aerobic count
    b.   Enterobacteriaceae
    c.    Total fungal count
  7. Test for specific pathogen
    a.    E. coli
    b.   Salmonella spp
    c.    S. aureus
    d.   Pseudomonas aeruginosa
  8. Test for Aflatoxins
    a.    B1
    b.   B2
    c.    G1
    d.   G2
  9. TLC / HPTLC with marker
  10. Dosage
  11. Shelf Life study
    a.    Normal
    b.   Accelerated

Protocol of testing Khalvi Rasaayana (Organo mineral / mineral preparations)

  1. Name of preparation
  2. Reference
  3. Organoleptic characters (Colour, taste etc)
  4. Ash value:
    a.    Total ash
    b.   Acid insoluble ash
  5. Test for heavy metals
    a.    Lead
    b.   Cadmium
    c.    Arsenic
    d.   Mercury
  6. Nambudri Spot Test
  7. Dosage
  8. Shelf Life study
    a.    Normal
    b.   Accelerated

Standards for other herbal dosage forms
Minimum assessment for other herbal dosage forms

Suspension

  1. Appearance
  2. Sedimentation volume
  3. Redispersibility
  4. Particle size distribution

Emulsions

  1. Appearance
  2. Sedimentation volume
  3. Redispersibility
  4. Particle size distribution
  5. Microbial count
  6. Coalescence (photomicrograph)

Capsules (hard / soft)

  1. Weight variation
  2. Content uniformity
  3. Disintegration time

Ointments

  1. Appearance
  2. Colour
  3. Homogeneity
  4. pH
  5. Metal particles

Abbreviations:

AFI = Ayurvedic Formulary of India
API = Ayurvedic Pharmacopoeia of India
GLP = Good Laboratory Practices
GMP = Good Manufacturing Practices
TLC = Thin Layer Chromatography
HPLC = High Performance Liquid Chromatography
AYUSH = Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, Ministry of Health & Family Welfare, Govt. of India

References:

  1. Anonymous, (2001) The Ayurvedic Pharmacopoeia of India (Part-1, Vol.3, 1st Edition), Govt. of India, Ministry of Health and Family Welfare, Dept of AYUSH.
  2. Anonymous (2001) The Ayurvedic Formulary of India (Part -2) 1st Edition
    Published by Govt. of India, Ministry of Health and Family Welfare, Dept of AYUSH.
  3. Sharma S.K., (2004) Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Medicines in India, Regional Training Course on Herbal Drug Industry for Compliance to Quality Parameters New Delhi, India.
  4. Mukherjee Pulok K & Verpoorte Robert (2003) GMP for Botanicals (Regulatory and Quality issues on Phyto-Medicines), Business Horizons Pharmaceutical Publishers, New Delhi.
  5. Mukherjee Pulok K (2002) 1st edition Quality control of drugs (an approach to evaluation of botanicals), Business Horizons Pharmaceutical Publishers New Delhi.
  6. Current Good Laboratory Practices Guidelines document for ISM & Homoeopathic drug testing laboratories, (2002) Dept of AYUSH, MoH&FW, Govt. of India.
  7. Good Manufacturing Practices notification, (2003), Dept of AYUSH, MoH&FW, Govt. of India.
  8. http://indianmedicine.nic.in/html/acts/act.htm (accessed on 13 March 2006)

Last updated on February 26th, 2021 at 12:14 pm

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