Pharmacopoeial Standards for Ayurvedic Drugs

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PHARMACOPOEIAL STANDARDS FOR AYURVEDIC DRUGS IntroductionIndia has Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules of 1945for drug regulation. Also Dangerous Drug Act, 1930 and Poisons Act 1919 definedrug 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 andother systems included in AYUSH; Government of India has specified the rulesand notifications related manufacturing, standardization and other aspects ofdrug usage. Ayurvedic, Unani and Homoeopathic Pharmacopoeias published bythe 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 toguide the drug analysts in maintaining high scientific and professional standardsfor ensuring only drugs of the highest quality are produced and marketed. In2003, government issued notification of Good Manufacturing Practices (GMP) toensure authentic, contamination free quality raw material, manufacturing processand product with desired quality standards. Guidelines for Quality ControlStandards for quality control are based on pharmacognostic, physicochemical,phytochemical and biological parameters. General process and parametersemployed in present standardization of herbal drugs is described below. 1. Sample collection as per suitable sampling plan 2. Identification

2.1. Organoleptic characterization2.2. Specific chemical tests (wherever available)2.3. Microscopic analysis2.4. Powder microscopy2.5. TLC comparison with authentic reference standard

3. Physico-chemical Analysis3.1. Moisture content3.2. Volatile / fixed oil determination3.3. Ash value (total, sulphated, acid insoluble, ash etc)3.4. pH of 5 % w/v suspension3.5. Extractive values (with various solvents like alcohol, water etc)3.6. Identity tests (like T.L.C., HPLC etc)

4. Phytochemical analysis4.1. Quantification of bioactive/marker compounds4.2. Quantification of characteristic category compounds (like flavanoids,

alkaloids, terpenoids, glycosides etc)


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5. Microbiological analysis5.1. Total viable aerobic court5.2. Total enterobacteriaceae5.3. Total fungal count5.4. Test of specific pathogens (S. aurus, E. coli, P. aeruginosa etc)

6. Residual analysis6.1. Foreign matter6.2. Heavy metals residues (Pb, Cd, Hg, As etc)6.3. Pesticide residues (organochloro, organophosperous etc)6.4. Mycotoxin residues (Aflatoxins B1, b2, G1, G2, Sterigatocistin,

Ochratoxin etc)6.5. Radioactive residues6.6. Solvent residues (volatile organic impurities)

7. Biological activities7.1. Dose response curve7.2. Dose and duration7.3. Limits of desired bioactivity

8. Toxicity or Safety profile8.1. Acute toxicity (including LD 50 value)8.2. Sub-acute toxicity

9. Other documentation

9.1. Rasa (Taste), Veerya (Predominant action), Vipaka (Metabolicaction)

9.2. Guna (Properties), Karma (Pharmacological action)9.3. Authentic/Textual References9.4. Important Formulations, Dose etc.9.5. Therapeutic Uses

10. Processing specifications

10.1. Details of manufacturing process10.2. Bhaavanaa, Mardana, Putà etc10.3. Shelf life, storage

Standards for classical dosage formsEach dosage form (Kalpanaa) has specific manufacturing process hence requiresseparate standards for assessment of quality and purity. Considering nature ofraw materials, processing and product; each formulation type has to be screenedfor various parameters like contamination (e.g. microorganisms), assessment ofexpected level of desired ingredients (e.g. Sugar) or results of manufacturingprocesses (e.g. extractive value after extraction).Standards for some of the classical dosage forms are described based oncompilation of various guidelines. Users are advised to go through references andfollow respective norms after proper scrutiny of local guidelines and legalconsiderations. (e.g. Each state or province might have different act, rules alsodifferent lists of banned drugs etc.)


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Protocol of testing Kvaatha (Decoction)1. Name of preparation:2. Reference3. Organoleptic Characters (Colour /Odour etc)4. pH5. Total solids6. Specific Gravity7. Test for heavy/toxic metals

a. Leadb. Cadmiumc. Test for Arsenicd. Mercury

8. Microbial Contaminationa. Total viable aerobic countb. Enterobacterciaceaec. Total fungal count

9. Test for specific Pathogensa. E. Colib. Salmonella Spp.c. S. aureusd. Pseudomonas aeruginosa

10. Test for Aflatoxinsa. B1b. B2c. G1d. G2

11. TLC/HPTLC- with marker (wherever possible)12. Pesticide residue

a. Organochlorine pesticidesb. Organophosphorous pesticidesc. Pyrethroids

13. Dosage14. Shelf life

a. Normalb. Accelerated

Protocol of testing Avaleha (Leha and Paaka)1. Name of preparation2. Reference3. Description:

a. Macroscopicb. Microscopic

4. Colour5. Odour6. Taste7. Consistency8. Total sugar9. Reducing sugar


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10. TLC/HPTLC11. Extractive value

a. Hexane volubleb. Alcohol solublec. Water soluble

12. Fat content13. Loss on drying at 105C14. Total solid content15. pH16. Specific gravity at 25C17. Ash value:

a. Total ash valueb. Acid insoluble ashc. Sulphated ash

18. Assay of main ingredients19. Crude fibre content (in case of Prakshepa Dravya)20. Test for heavy metals

a. Leadb. Cadmiumc. Arsenicd. Mercury

21. Microbial contamination.a. Total Bacterial countb. Total fungal count

c. Enterobacterciaceae

d. Salmonella Spp.

22. Ayurvedic specificationa. Supakvam

b. Tantumatatvam

c. Apsumajati

d. Karatvam Pidite mudrae. Gandha Varnà Rasaodbhavam

23. Therapeutic indications24. Dose25. Shelf life


Protocol of testing Taila / Ghrita1. Name of preparation2. Reference3. Description4. Colour (RYB value)5. Odour6. Rancidity7. Coagulation point8. Specific gravity (wt. /ml.) at room temperature9. Refractive index at 25C


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10. Viscosity11. Specific tests

a. Saponification valueb. Acid valuec. Iodine valued. Peroxide value (residue)e. Free Fatty acidsf. 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 ingredients14. Therapeutic use15. Dosage16. Congealing point (for Ghrita only)17. Shelf Life study

a. Normalb. Accelerated.

Protocol of testing Guggulu (Guggulu based formulations)1. Name of preparation:2. Reference3. Description

a. Identificationb. Macroscopicc. Microscopicd. Uniformity by weight

4. pH5. Extractives

a. Alcohol soluble extractb. Water extract

6. Loss on drying on 105C7. TLC8. Ash value:

a. Total ashb. Acid insoluble ash

9. Description: general, including colour, odour, taste etc10. Volatile oil contents (Oleo gum resin)11. Test for resin12. Assay for main ingredients13. Disintegration time14. Metal compound contents (as per Bhasma if added)15. Test for heavy metals


16. Microbial contaminationa. Total viable aerobic count


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b. Enterobacteriaceaec. Total fungal count

17. Test for specific pathogena. E. colib. Salmonella sppc. S. aureusd. Pseudomonas aeruginosa


19. Pesticide residuea. Organochlorine pesticidesb. Organophosphorus pesticidesc. Pyrethroids

20. Therapeutic indications21. Dose22. Shelf Life study


Protocol of testing Bhasma1. Name of preparation2. Reference3. Method of preparation

a. Method of S`hodhana (purification) with referenceb. Method of Bhasma formation with referencec. Types & No. of Putà (Incunation)d. Bhavana Dravya Used (Trituration material used)

4. Description (colour & texture)5. Particle size6. Loss on drying7. Acid insoluble ash8. Water solubility.9. Organoleptic characters: general, including colour, odour, taste etc10. Heavy metal test


11. Assay (of main ingredients)12. Namburi Spot Test13. Ayurvedic specifications

a. Lusterless (Nis`hchandrikaa)b. Fineness (fine enough to enter in lines of finger - Rekhaapoornàtva)c. Floats on water (Vaaritara)d. Smokeless (Nirdhooma)e. Tasteless (Nisvaadu)


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f. Irreversible (Apunarbhava)14. Dose15. Method of administration16. Toxicity report17. Shelf Life study


(In the final product Bhasma, metals are the compounds forms which are nottoxic.) Protocol of testing Vatì / Gutìkaa (pills & tablets)1. Name of preparation:2. Reference3. Description4. Physical characteristics

a. Colourb. Odourc. Tasted. Macroscopic characteristicse. Microscopic characteristicsf. Textureg. Size

5. TLC, HPTLC profile

6. Loss on drying at 110 0 C7. Ash value:

a. Total ashb. Acid insoluble ashc. Sulphated ash

8. Study of extractivesa. Alcohol soluble extractsb. Water soluble extracts

9. Test for heavy metalsa. Leadb. Cadmiumc. Arsenicd. Mercury

10. Microbial contaminationa. Total viable aerobic countb. Enterobacteriaceaec. Total fungal count


12. Test for Aflatoxinsa. B1b. B2c. G1


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d. G213. Pesticide residue

a. Organochlorine pesticidesb. Organophosphorus pesticidesc. Pyrethroids

14. Shelf life studya. Normalb. Accelerated

15. Average weight16. Disintegration time17. Hardness18. Friability19. Content uniformity20. Metal content21. Weight variation22. Usual dose23. Therapeutic indications Protocol of testing Lauha / Man`dòora (Preparations of iron prominence)1. Name of preparation2. Reference3. Description4. Physical characteristics

a. Macroscopic characteristicsb. Microscopic characteristics

5. Particle size

6. Loss on drying at 105 0 C7. Ash value:


8. Study of extractivesa. Alcohol soluble extractsb. Water soluble extracts




12. Test for Aflatoxinsa. B1b. B2


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c. G1d. G2

13. TLC, HPTLC profile14. Ayurvedic specifications

a. Lusterless (Nis`hchandrikaa)b. Fineness (fine enough to enter in lines of finger - Rekhaapoornàtva)c. Floats on water (Vaaritara)d. Smokeless (Nirdhooma)e. Tasteless (Nisvaadu)f. Irreversible (Apunarbhava)

15. Shelf life studya. Normalb. Accelerated

Protocol of testing Kshaara / Lavanà (compounds of salts)1. Name of preparation2. Reference3. Description

a. Colourb. Odourc. Tasted. Texture

4. Identification: chemical test applicable to identify major

5. Loss on drying at 105 0 C6. pH7. Acid insoluble ash8. Solubility in water9. Assay for specific salt10. Therapeutic indications11. Dose and method of administration Protocol of testing Choornà (powders)1. Name of preparation2. Reference3. Description4. Particle size5. Identification:

a. Macroscopicb. Microscopicc. Phyto-chemical tests assay wherever possibled. TLC

6. Study of extractivesa. Hexane soluble extractsb. Alcohol soluble extractsc. Water soluble extracts

7. pH8. Loss on drying at 105 degree C.9. Ash value


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14. TLC / HPTLC with marker15. Pesticide residue

a. Organochlorine pesticidesb. Organophosphorus pesticidesc. Pyrethroids

16. Therapeutic indication (Ref. to AFI)17. Method of application to be specified.18. Shelf life study


Protocol of testing Aasava / Aristha1. Name of preparation:2. Reference2. Description

a. Macroscopicb. Microscopic

3. Colour (RYB Value)4. Odour5. pH6. Specific Gravity at 25º C7. Total Solids8. Alcohol Contents9. Non reducing sugars10. Reducing sugars11. TLC/HPTLC12. Test for methanol13. Total acidity


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14. Safety profile15. Test for heavy metals

LeadCadmiumArsenicMercury

16. Dosage17. Shelf life study


Protocol of testing Arka1. Name of preparation:2. Reference3. Description4. Colour5. Odour6. pH7. Volatile Matter8. Specific Gravity at 25º C9. Clarity Test /Suspended Particles10. Sterility Test11. Assay12. TLC /HPTLC/GLC13. Dosage14. Shelf Life study


15. Microbial contamination Protocol of testing Parpatèe1. Name of preparation2. Reference3. Colour4. Touch5. Particle size6. Lusterless (Nis`hchandrikaa)7. Loss on drying at 105 º C8. Assay of Mercury and Sulphur9. Dosage10. Shelf Life study


Protocol of testing Kupipakva Rasaayana (Mercurial compounds)1. Name of preparation2. Reference3. Organoleptic characters (Colour, taste etc)4. Ash value:


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9. TLC / HPTLC with marker10. Dosage11. Shelf Life study


Protocol of testing Khalvi Rasaayana (Organo mineral / mineral preparations)1. Name of preparation2. Reference3. Organoleptic characters (Colour, taste etc)4. Ash value:



6. Nambudri Spot Test7. Dosage8. Shelf Life study


Standards for other herbal dosage formsMinimum assessment for other herbal dosage forms


NPLNQï ï ï K~óì ëçÑíKÅÇ~ÅKáåLéëÜçã ÉL~ééëLÉåLëêÅL̂ êíáÅäÉëL£Lpí~åÇ~êÇë| Ñç ê| î ~êáç ì ë| Çêì ÖëKÜíã

Suspension1. Appearance2. Sedimentation volume3. Redispersibility4. Particle size distribution Emulsions1. Appearance2. Sedimentation volume3. Redispersibility4. Particle size distribution5. Microbial count6. Coalescence (photomicrograph) Capsules (hard / soft)1. Weight variation2. Content uniformity3. Disintegration time Ointments1. Appearance2. Colour3. Homogeneity4. pH5. Metal particles Abbreviations:AFI = Ayurvedic Formulary of IndiaAPI = Ayurvedic Pharmacopoeia of IndiaGLP = Good Laboratory PracticesGMP = Good Manufacturing PracticesTLC = Thin Layer ChromatographyHPLC = High Performance Liquid ChromatographyAYUSH = Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha andHomoeopathy, 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 ofAYUSH.

2. Anonymous (2001) The Ayurvedic Formulary of India (Part -2) 1st EditionPublished by Govt. of India, Ministry of Health and Family Welfare, Dept ofAYUSH.

3. Sharma S.K., (2004) Infrastructure & Regulatory Aspect of Ayurvedic,Siddha & Unani Medicines in India, Regional Training Course on Herbal DrugIndustry for Compliance to Quality Parameters New Delhi, India.

4. Mukherjee Pulok K & Verpoorte Robert (2003) GMP for Botanicals (Regulatoryand Quality issues on Phyto-Medicines), Business Horizons PharmaceuticalPublishers, New Delhi.


NQLNQï ï ï K~óì ëçÑíKÅÇ~ÅKáåLéëÜçã ÉL~ééëLÉåLëêÅL̂ êíáÅäÉëL£Lpí~åÇ~êÇë| Ñç ê| î ~êáç ì ë| Çêì ÖëKÜíã

5. Mukherjee Pulok K (2002) 1st edition Quality control of drugs (an approachto evaluation of botanicals), Business Horizons Pharmaceutical Publishers NewDelhi.

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)

http://indianmedicine.nic.in/html/acts/act.htm

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Pharmacopoeial Standards for Ayurvedic Drugs