COUNTRY PAPER FOR

INTERNATIONAL CONCLAVE

Presentation by:
DR. S.K. SHARMA, M.D. (AY.), PH. D.,
ADVISER (AYURVEDA)
Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha,
Homoeopathy (AYUSH)
Ministry of Health & Family Welfare,
Government of India
URL:www.indianmedicine.nic.in
Telefax : 011-23328576
E-mail : adv_ayurveda@yahoo.com
 ANTIQUITY OF AYURVEDA
Ayurveda is a very well documented System of Health
Care Practiced in Indian Sub-Continent
The Antiquity dates back to 1000-500 BC.
- It is believed that Lord Brahma created Ayurveda
along with the creation of mankind and universe
- Vedas (5000 B.C.) describe about 100 plants and
treatment of various diseases
- Since the 1000-500 BC, Ashtang Ayurveda (eight
specialities of Ayurveda) are in practice in one or the
other way
- Official Recognition by Government
Important Features of Sushruta (500BC)

- Basic Concepts of Surgery,

Instruments & Eight Surgical procedures
- Chapter on Plastic Surgery
- Concept of Infection
- Burns, Snowbite, frostbite
- Concept of Pre-operative, operative & Post-
operative Care
- Wound Healing
- Eight Specialties of Ayurveda
 INDIAS STRENGTH

Having 16 Agro-climatic zones.

Is one of 12 mega biodiversity countries.
Has 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
5,64,476 - Registered ISM Practitioners
3100 ISM Hospitals
22,735 ISM Dispensaries (Government)
 Strength of Indian Medicine in
India
Particulars Modern Medicine Indian Medicine
Ayurveda/U/S
Practitioners 4,40,000 5,64,476
Indoor Hospitals 5,767 3100

Graduate training 242 284

Colleges
Manufacturing 16,000 9,000
Units
Turnover 30,000 6,500
(Rs. Crores)
 BASIC CONCEPTS OF AYURVEDA:

Human being Vs Universe

Human being is a replica of universe:
Microcosm - Macrocosm
Five elements - Space, Air, Fire, Water & Earth
Vatta,Pitta,Kapha - Air, Sun & Water +Earth
Atma (Soul) (consciousness) - Parmatma (super consciousness)

Human being and environment around are very much similar and
inter-dependent
 HUMAN BEING Vs FOOD & DRUGS

Human being is a conglomeration

of Body+Mind+Intellect+Soul
Food Human body Drugs:
Space Vata Space
Air Vata Air
Fire Pitta Fire
Water Kapha Water
Earth Kapha Earth
Vata, Pitta, Kapha = Tridosha
 STATE OF HEALTH
Health is a state of structural and functional
balance of body components and happiness of
mind & soul
- Sam-Dosha - Vatta,Pitta & Kapha [Humours]
- Sam-Agni - Biological fire
- Sam Dhatu - Body tissues
- Malkriya - Normal excretion of wastes -
- urine, stool, sweat etc.
- Normal functions of 5 motor and 5 sensory
organs
Happiness of mind & soul

Equilibrium of all these factors is health

 CONCEPT OF PRAKRITI

(Body, Mind,Temperament)
- Prakriti is decided at the time of fertilization
- Sperm+ovum+mental state of couple and
environment
- Genetically constituted body,mind, personality

- Body constitution-Types: Vata type (V),

Pitta type (P), Kapha type (K), VP, VK, PK or VPK

- Mental Temperament-Types: Satvik(S),

Rajsik (R), Tamsik (T), SR, ST, RT, SRT
Application of the Concept of Prakriti for the
Prevention and Management of Disease :

- Original prakriti is genetically formed,

therefore cannot be changed
- Prakriti assessment record will provide a health
profile of the individual
- Individual will know his personality
- Diet, sleep, exercise and other behaviour can be
monitored to suit ones prakriti
- Preventive measure to prevent the possible
diseases
- One can modify life style to suit his prakriti
 DISEASE AND TREATMENT
Relating Concepts

- Imbalance of Tridosha results in

diseases.
- Tridosha are excessive or deficient in
disease conditions.
- To bring back the equalibrium of
Tridosha is the essence of treatment &
Health.
- Balance of Tridosha is achieved by
health related Dos Donts, Diet &
Medicines.
 Ayurveda A Fully Developed
Medical System

1. Education System - IMCC (Act 1970)

2. Registration of Practitioners IMCC
(Act 1970 & State Acts)
3. Regulation of Medical Drug Drugs &
Cosmetic Act 1940
4. Research & Development
 COURSES OF STUDY FOR AYURVEDA,
SIDDHA & UNANI SYSTEMS IN INDIA

1. Graduation *B.A.M.S/ B.S.M.S// B.U.M.S. 5 -1/2 years

2. Post graduation *M.D./M.S (Ayurveda) 3 years
(16 specialties)
3. Post doctorate Ph.D. (Ayurveda) (Minimum 2 years)

4. Membership Course MRAV 2 years

(Member of Rashtriya Ayurved Vidyapeeth)
5. Short & Mid term Certificate or 2 months to
Courses Diploma 2 years

Courses recognised by Central Council of Indian Medicine

 Course contents of Degree Courses of
Ayurveda/Unani/Siddha/Homeo (5.5 years)

First professional (1.5 years)

1. Ayurveda ka Itihas- History of Ayurveda
2. Sanskrit- Sanskrit
3. Padartha Vigyan- Philosophy & Fundamentals
4. Astanga Sangraha- A text of Ayurveda
5. Rachna Sharira- Anatomy- Modern & Ancient
6. Kriya Sharira- Physiology-Modern & Ancient
7. Swastha Vritta- Preventive & Social Medicine

contd
Second professional (1.5 years)

8. Rasa Shastra Avam Bheshajya Kalpana-

Ayurvedic Pharmaceuticals
9. Dravyaguna Vigyan- Materia medica /
Medicinal plants
10. Agad Tantra, Vyahar Ayurveda Avam Vidhi
Vaidyaka- Toxicology and Jurisprudence
11. Rog Vigyan Avam Vikrit Vigyanam-Pathology
& Pathogenesis
12. Charaka Samhita- Text Book of Medicine
Third professional (1.5 years)

13. Kaya Chikitsa- Internal Medicine

14. Shalakya Tantra- Eye
15. Shalakya Tantra- ENT
16. Prasuti Tantra and Striroga- Gynaecology &
Obstetrics
17. Kaumara Bhritya- Pediatrics
18. Charaka Samhita-Text of Internal Medicine

30 % Modern Medicine e.g. Gynaecology &

Obstetrics, Pediatrics, Internal medicine, surgery, eye
& ENT are also taught in Ayurvedic Degree Course
One year internship in hospital is essential
 Nomenclature of Post-graduate
degree in respective specialties
M.D. (Ayurveda) Ayurveda Sidhanta
M.D. (Ayurveda) Ayurved Samhita
M.D. (Ayurveda) Rachna Sharir
M.D. (Ayurveda) Kriya Sharir (Dosha- Dhatu-Mala)
M.D. (Ayurveda) Dravya Guna Vigyana
M.D. (Ayurveda) Ras Shastra
M.D. (Ayurveda) Bhaishajya Kalpana
M.S. (Ayurveda) Prasuti Tantra Avum Stri Roga
M.D. (Ayurveda) Kaumar Bhritya Bala Roga

M.D. in 22 specialties has been approved

 COMPONENTS OF AYURVEDIC
MEDICINES

Plants : 90-95 %
Minerals : 1-2 %
Metals : 1-2 %
Animal Products : 1-2 %
Marine Products : 1-2 %
These are used in single and multiple
ingredients forms
 Concept of Shodhana of a Drug
(Purification & Detoxification of the
Raw Drugs)
Objects to ensure Safety:
1. To remove the undesirous effect of raw
drugs.
2. To remove the toxic effect of raw drug
3. To dilute the medicinal effect of drug
suitable as medicine
4. The purification is done by various
processes of mixing, boiling of the raw
drug with other substances with specific
properties, Drying etc.
DOSAGE FORMS OF AYURVEDIC FORMULATIONS
(Multiple Ingredients)

Sl. No. Dosage Form No. of ingredients Dose

1. Swarasa (Expressed Juice) 1-3 5-10 ml.
2. Churna (Powder of the combinations)3-20 3-5 gm.
3. Kwath Churna (Coarse power for 3-15 0-30 gm.
making decoction)
4. Pravahi Kwath (Preserved decoction 3.20 10-20 ml.
- ready for use)
5. Asava and Arishta ( Fermented liquids 5-20 20-30 ml.
- multiple ingredients)
6. Arka (Distilled medicated water) 1-3 10-20 ml
7. Avaleha (Jam like formulations) 10-50 5-10 gm.
DOSAGE FORMS OF AYURVEDIC FORMULATIONS

Sl.No. Dosage Form No. of ingredients Dose

8. Paka Khand (Confectionary 10-25 5-10 gm.

like formulation)
9. Guggulu (Guggulu base formulation 5-20 1-3 gm.
in tab./pill form)
10. Ghrita (Classified butter based 5-20 5-10 gm.
formulations)
11. Taila (Medicated/oil based 10-20 External
formulations)
12. Lepa (For external applications) 5-15 External
13. Malhara (Ointment) 3-5 External
 DOSAGE FORMS OF AYURVEDIC FORMULATIONS
(multiple ingredients) contd.
Sl.No. Dosage Form No. of Single
ingredients dose
14. Satva/Ghansatva - total water extract 1-3 1/2 - 1 gm.

15. Vati/Gutika (tablet/pill) 5-20 1/2 - 1 gm.

16. Panaka (syrups) 5-15 10-20 ml.

17. Capsules 5-10 2

18. Aaschayotana (Eye drops) 3-5 Local use

19. Karn bindu (Ear drops) 5-10 Local use

20. Nasaya (Nasal drops/insulation) 5-10 Local use

DOSAGE FORMS OF AYURVEDIC FORMULATIONS
(multiple ingredients) contd.

Sl.No. Dosage Form No. of Single

Ingredients dose

21. Bhasma - (Calcinated ash); 1-3 50-100 mg.

- (i) Mineral based ash-Compounds of Minerals)
- (ii) Metal based ash-Compounds of Metals)

22. Lauh & Mandora - 5-20 1gm.

- (Iron ash based formulations);

23. Ras Yoga - (Herbo-mineral formulations)

- (i) Kupipakva 2-5 50-100 mg.
- Metallic compounds
- (ii) Rasayoga - Herbo-mineral 5-20 125-250 mg.
- -metallic formulations
 Authentication
Heavy Metal Foreign Matter
Contaminants
Organoleptic
Microbial Count Evaluation

Pesticide Macroscopy &

STANDARDIZATION Microscopy
Residue OF AYURVEDA DRUGS

Marker Volatile
Component Matter

Chromatographic Ash Value

Profile
Extractive Value

Authentication and Standardization of Herbal Raw Material

 Standardization of Herbal Ayurvedic Drugs
For Global Competitiveness:

Raw materials Process

Authentication Material/energy inputs

Physico, chemical, biological limits Operational uniformity

Storage conditions Safety and occupational health

Size/shape/right quality Intermediate quality [in process

quality control
Chromatographic fingerprint
Chromatographic fingerprint
Product
Organolepthic . Physico chemical properties
Chromatographic fingerprint
Assay [Chemical / biological]
Storage stability
User safety
Packaging and labelling
 Chromatograph-finger-print
markers for Herbal Drugs
Markers are chemically defined constituents of
a herbal drug which are of interest for control
purposes independent of whether they have
any therapeutic activity or not

Markers may serve to calculate the quantity of

herbal drug or preparation in the finished
product if that marker has been quantitatively
determined in the herbal drug or preparation
when the starting materials are tested
 TLC FINGER-PRINT Sennae folium, fructus
A HNO3-Potassium hydroxide reagent (UV 365 nm)
B Sodium metaperiodate reagent (UV 365 nm)

Solvent system:- n-propanol : Ethylacetate : Water : gl. acetic acid (40:40:29:1)

1 Sennae fructus (methanol ext. 20 uL)
2 Sennae folium (methanol ext. 20 uL)
T1 Sennoside A T2 Sennoside B
 PHARMACOPOEIAL MONOGRAPHS ON
AYURVEDIC DRUGS AND FORMULATIONS

AIMS
CONTROL OF PRODUCT QUALITY IN TERMS OF:
Identity
Purity
Strength

PLANT DRUGS -> UNPROCESSED PLANT PARTS AS DRUGS (PD)

38
 Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India (API) Monograph

1. Official - name of the drug - Sanskrit/Ayurvedic)

2. General Introduction:
3. Synonyms e.g., Regional names etc.
4. Description :
(a) Macroscopic, description
(b) Microscopic (Pharmacognostic), description
- Root -Flower
- Stem -Fruit
- Leaf -Seed
5. Powder - diagnostic features
6. Chemical constituents
 Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India(API) Monograph
..contd.
Standards of Identity, Purity and Strength

Foreign matter - not more than..%

Total Ash - not more than..%
Acid insoluble ash - not more than.%
Alcohol soluble extraction - not less than.%
T.L.C. (IDENTITY TEST) (with method & description)
Assay method of major chemical constituent
Properties and Action:
(i) Rasa (Taste)
(ii) Guna (Properties)
(iii) Virya (Predominant action)
(iv) Vipaka (Metabolic action)
(v) Karma (Pharmacological action)
 Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India(API)
Monograph contd

Test for Heavy Metals -----

Microbial Load -----
Important Formulations: -----
Therapeutic Uses: -----
Dose: -----
Authentic/Textual References -----
 AYURVEDIC PHARMACOPOEIA OF INDIA [API]

ABOUT 1000 SINGLE DRUGS AND 8000 COMPOUND

FORMULATIONS OF RECOGNIZED MERIT ARE USED IN
INDIA.
AYURVEDIC PHARMACOPOEIAL COMMITTEE [APC]
TARGETED STUDY ON 600 SINGLE DRUGS.
FIVE VOLUMES OF AYURVEDIC PHARMACOPOEIA OF INDIA
(API) HAVE BEEN PUBLISHED.
API VOL I 80 drugs
API VOL II 78 drugs
API VOL III 100 drugs
API VOL IV 68 drugs
API VOL.V 92 drugs
Total 418 drugs
API Vol. VI & VII are in pipeline - 160 drugs
 Ayurvedic Drugs Undertaken by
British Pharmacopoeia Commission

Sl. Botanical Name Sanskrit Name

No.
1. Asparagus racemosus Willd Rhizome Shatavari
2. Emblica officinalis Gaertn. Dried fruit Amalaki dried fruit
3. Terminalia arjuna W and A stem bark Arjuna
4. Tinospora cordifolia (Willd.) Miers. stem Guduchi
5. Bacopa monnieri (Linn.) Wettst., whole plant Brahmi (Jal brahmi)
6. Terminalia chebula Retz. fruit Haritaki
7. Withania somnifera (Linn) Dunal. Root Asvagandha
8. Azadirachta indica A. Juss., leaf Nimba
9. Rubia cordifolia Linn., root Manjishta
10. Eclipta alba. Hassk, whole plant Bhrngaraja
contd
 Ayurvedic Drugs Undertaken by
British Pharmacopoeia Commission
Sl. Botanical Name Sanskrit Name
No.
11. Santalum album Linn., heartwood Svetacandana
12. Piper longum Linn., fruit and root Pippali/Pippalimoola
13. Terminalia belerica. Roxb. Fruit Bibhitaki
14. Tribulus terrestris Gokshura
15. Convolvulus pluricaulis Sankaspuspi
16. Embelia ribes Burm. F., fruit Vidanga
17. Phyllanthus niruri Bhumiamla
18. Valeriana wallichi DC, rhizome Tagara
19. Celastrus paniculatus-seeds Jyotismati
20. Gymnema sylvestre, leaf Gurmar/Meshasringi
 Ayurvedic Formulary of India (AFI)

Book of multiple ingredient formulation

most commonly used by the Physician
- Two Volumes containing 636 formulations
- Contains ingredient Drugs with Botanical
Names, part used
- Methods of Preparation
- Dosage form & Dose
- Indications & contraindications
 Pharmacopoeial Standards of Multiple
Ingredient Ayurvedic Formulations

1. To develop SOPs of manufacturing process of formulation

2. To develop standards of identity, purity and strength of
ingredients & compound formulation
3. Pharmacognostic & chemical standardization Shelf life
studies
4. Fifteen Laboratories & manufacturing companies are
working on SOPs
5. Pharmacopoeial Standards of 100 formulation have been
worked out.
6. Annual Target is 100 formulations per year to cover 300-400
most widely used in 3-4 years.
 GOVERNMENT INITIATIVES

Setting up of Department of ISM&H in 1995

renamed as Department of AYUSH in 2003.
Setting up of National Medicinal Plants
Board (NMPB) in 2000 to make available
raw material of quality, efficacy and safety
to AYUSH industries/pharmacies and
promote exports through value addition.
Pharmacopoeial laboratories of Indian
medicines for laying down SOPs and
pharmacopoeial standards.

Contd.
 GOVERNMENT INITIATIVES
Preparation of pharmacopoeias of
Ayurveda so far five volumes of API
containing standards for 418 drugs.
Separate chapter for ASU medicines in
Drugs & Cosmetics Act, 1940.
Good Manufacturing Practices (GMPs),
non GMP units to be delicensed.
Provisions regarding mandatory testing
for heavy metals made mandatory from 1st
January, 2006.
 ACHIEVEMENTS
Conservation and Herbal Gardens 28,000 ha.
Cultivation through contract farming 32,000 ha.
Raising of quality planting material 660 lakhs
(nos.)
Awareness extension and capacity building.
R&D for standardisation, revalidation trials, germ
plasm banks, development of protocols for micro
propagation and development of agro-techniques.
Setting up of state level Boards at provincial level.
Steps initiated for evolving country specific
GAP,GCP, GSPs.
 PHARMACOPOEIAL LABS &
TESTING FACILITIES FOR
AYURVEDIC DRUGS

1. Pharmacopoeial Laboratory for Indian Medicine

(PLIM) established in 1970 & 20 other
laboratories (For evolving Pharmacopoeial
Standards of Ayurveda drugs)
2. University/Council for Scientific & Industrial
Research and other National Laboratories are
associated for pharmacopoeial work
3. 26 State Drug Testing Laboratories for Ayurvedic
drugs supported in states
 G.M.P. FOR AYURVEDIC MEDICINES

Good Manufacturing Practices (GMP) for

Ayurvedic, Unani and Siddha drugs have
been implemented on 23rd June, 2000. WHO
guidelines have been kept in mind while
preparing the document.

5500 Units are GMP compliant

2500 Non-GMP compliant units stopped
production
 G.M.P. FOR AYURVEDIC MEDICINES:

Standards laid down for:

Storage of raw material/proper

authentication
Manufacturing area, machines & processing
Record keeping, SOPs
In-house quality control & quality assurance
Finished goods store
Working conditions of all sections
 On GMP for Ayurveda/Siddha/Unani Drugs

GMP certificate is a must if you are going to produce any

Ayurveda products

GMP Requirements
- Raw Materials-prescribed quality and free from contamination
- Manufacturing process-infrastructure, staff
- QC-adequate measure to be adopted, documents

- To achieve the objectives listed above, each licensee shall evolve

methodology and procedures for following the prescribed process
of manufacturing of drugs which should be documented as a
manual and kept for reference and inspection

*Ref: Schedule T, Drugs & Cosmetic Act Notification (June, 2000), ISM & H, Min Health, GOI
 INDIAN DRUGS & COSMETIC ACT, 1940
REGULATION OF AYURVEDIC DRUGS

Separate Chapter IVA for Ayurveda, Siddha &

Unani medicines deals with the Section 33-C of the
Drugs & Cosmetics Act, 1940 in 1982.
Separate Drug Technical Advisory Board under
Drugs & Cosmetics Act, 1940 for ASU drugs to
advise Government on all aspects related to quality
control and drug standardization.
Separate Drugs Consultative Committees set up for
securing uniform administration of the Act
throughout India.
State wise Drugs Licensing/Controlling Authorities.
 IMPORTANT PROVISIONS OF
INDIAN DRUGS & COSMETICS ACT

* Regulation of manufacture for sale of Ayurvedic

drugs through drug manufacturing license
system.
* Prohibition of manufacture and sale of certain
drugs.
* Power of Central Government to prohibit
manufacture etc. of drugs in public interest.
* Provision for Government Drug Analysts.
* Provision for Inspectors to visit factory.

contd...
 IMPORTANT PROVISIONS OF INDIAN DRUGS &
COSMETICS ACT RELATING TO AYURVEDIC
MEDICINES

* Penalty for manufacture, sale etc., of drugs in

contravention of the Act (Section 33 J).
* Penalty for subsequent offences.
Prescribe qualifications and duties of the
Government Analysts.
Prescribe methods of testing and analysis.
To establish Laboratories for Testing and
Analysis of Drugs.
Schedule - E of Drug Act prescribe list of
poisonous material used in ASU drugs
require special safeguards
contd
 IMPORTANT PROVISIONS OF INDIAN DRUGS &
COSMETICS ACT RELATING TO AYURVEDIC
MEDICINES
contd..

- Describe mis-branded (Section 33 E) adulterated (Section 33 EE)

and spurious drugs (Section 33 EEE)
for punitive action (fine/imprisonment)
- Power of Central Government to make Rules under the Act
- Schedule-T, Prescribe Good Manufacturing Practices(GMP)
- Labeling/packing provisions for domestic use as well as export
- Rule 160-A Recognize public, private Drug Testing
Laboratories for sample analysis
- Guidelines of Good Laboratory Practices (GLP)
 Indian Drugs & Cosmetic
Act - Spurious Drugs (ASU)

1. Section 33 E Mis-branded drugs

2. Section 33 EE Adulterated drugs
3. Section 33 EEE Spurious Drugs
Penalty: Section 33 J
Imprisonment up to six months and
(fine not less than Rs. 1,000)
 Labeling provisions (Rule-161)

Label must have the following:

1. Name of formulation
2. True list of ingredients used in the formulation
together with the quantity of each ingredient
3. If the list is long a separate list be enclosed with
the packing and reference be made on the label.
4. If ingredients are from schedule E(I) the word
Caution: to be taken under medical supervision
should be printed both in English & Hindi.
Contd..
 Contd

Labeling provisions (Rule-161)

5. Correct statement of weights & measures

6. Name and address of the Manufacturer
7. Manufacturing License Number.
8. Batch Number.
9. Date of Manufacturing & Expiry Date
10. Specifically indicates Ayurveda Medicine/Siddha
Medicine/Unani Medicine
11. FOR EXTERNAL USE ONLY(whenever
applicable be printed)
12. Testing for Heavy Metal limits for export is
mandatory w.e.f. 1.1.2006 for export.
 Research in Ayurveda
1. CCRAS- Central Council for Research in Ayurveda
& Siddha
2. ICMR-Indian Council for Medical Research
3. CSIR- Council for Scientific & Industrial Research
4. DST Department of Science & Technology
5. DBT Department of Bio-technology
6. No. of Allopathic Medical Colleges
7. BHU, AIIMS, NIMHANS
8. Golden Triangle Initiative (GTP) of AYUSH, CSIR &
ICMR
 New Futuristic Initiatives
1. AYUSH Ayurvedic Pharmacopoeia Commission
2. Golden Triangle Projects [G.T.P] to validate
Ayurvedic Products
3. Standardization of Ayurvedic Education ,
Publication of minimum Standards of Education
4. Support to Ayush Drugs Industries
5. More Focus on Collaborative Research in
Ayurveda.
6. Initiative for Global promotion of Ayurveda
7. Continuation of TKDL Project to safe guard
patents