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 & Postoperative 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
Indoor Hospitals

4,40,000

5,64,476

5,767

3100

242

284

Manufacturing
Units

16,000

9,000

Turnover
(Rs. Crores)

30,000

6,500

Graduate training
Colleges

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 -

Malkriya

Body tissues
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
environment

state

of

couple

and

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:
Rajsik (R), Tamsik (T), SR, ST, RT, SRT

Satvik(S),

Application of the Concept of Prakriti for the

Prevention and Management of Disease :
Original prakriti is
genetically
therefore
cannot be changed

formed,

Prakriti assessment record will provide a

profile of the individual

Individual will know his personality

health

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.
2. Post graduation *M.D./M.S (Ayurveda)

5 -1/2 years
3 years

(16 specialties)

3. Post doctorate
4. Membership Course

Ph.D. (Ayurveda)
MRAV

(Minimum 2 years)
2 years

(Member of Rashtriya Ayurved Vidyapeeth)

5. Short & Mid term

Courses

Certificate or
Diploma

2 months to
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.
2.
3.
4.
5.
6.
7.

Ayurveda ka Itihas- History of Ayurveda

Sanskrit- Sanskrit
Padartha Vigyan- Philosophy & Fundamentals
Astanga Sangraha- A text of Ayurveda
Rachna Sharira- Anatomy- Modern & Ancient
Kriya Sharira- Physiology-Modern & Ancient
Swastha Vritta- Preventive & Social Medicine
contd

Second professional (1.5 years)

8.
Rasa Shastra Avam Bheshajya KalpanaAyurvedic 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)
M.D. (Ayurveda)
M.D. (Ayurveda)
M.D. (Ayurveda)
M.D. (Ayurveda)
M.D. (Ayurveda)
M.D. (Ayurveda)
M.S. (Ayurveda)
M.D. (Ayurveda)

Ayurveda Sidhanta
Ayurved Samhita
Rachna Sharir
Kriya Sharir (Dosha- Dhatu-Mala)
Dravya Guna Vigyana
Ras Shastra
Bhaishajya Kalpana
Prasuti Tantra Avum Stri Roga
Kaumar Bhritya Bala Roga

M.D. in 22 specialties has been approved

COMPONENTS OF AYURVEDIC
MEDICINES
Plants
Minerals
:
Metals
Animal Products
Marine Products

:
90-95 %
1-2 %
:
1-2 %
:
1-2 %
:
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
1. Swarasa (Expressed Juice)
1-3
2. Churna (Powder of the combinations) 3-20
3. Kwath Churna (Coarse power for
3-15
making decoction)
4. Pravahi Kwath (Preserved decoction 3.20
- ready for use)
5. Asava and Arishta ( Fermented liquids 5-20
- multiple ingredients)
6. Arka (Distilled medicated water)
1-3
7. Avaleha (Jam like formulations)
10-50

Dose
5-10 ml.
3-5 gm.
0-30 gm.
10-20 ml.
20-30 ml.
10-20 ml
5-10 gm.

DOSAGE FORMS OF AYURVEDIC

FORMULATIONS
Sl.No.

Dosage Form

No. of ingredients

Dose

8.

Paka Khand (Confectionary

like formulation)

10-25

5-10 gm.

9.

Guggulu (Guggulu base formulation

in tab./pill form)
Ghrita (Classified butter based
formulations)
Taila (Medicated/oil based
formulations)
Lepa (For external applications)
Malhara (Ointment)

5-20

1-3 gm.

5-20

5-10 gm.

10-20

External

5-15
3-5

External
External

10.
11.
12.
13.

DOSAGE FORMS OF AYURVEDIC FORMULATIONS

(multiple ingredients)
contd.
Sl.No.

Dosage Form

No. of
ingredients
14. Satva/Ghansatva - total water extract
1-3

Single
dose
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

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
Ingredients

21. Bhasma - (Calcinated ash);

1-3
(i) Mineral based ash-Compounds of Minerals)
(ii) Metal based ash-Compounds of Metals)
22. Lauh & Mandora (Iron ash based formulations);

5-20

23. Ras Yoga - (Herbo-mineral formulations)

(i) Kupipakva
2-5
Metallic compounds
(ii) Rasayoga - Herbo-mineral
5-20
-metallic formulations

Single
dose
50-100 mg.

1gm.

50-100 mg.
125-250 mg.

Authentication
Heavy Metal
Contaminants

Foreign Matter
Organoleptic
Evaluation

Microbial Count
Pesticide
Residue

STANDARDIZATION
OF AYURVEDA DRUGS

Volatile
Matter

Marker
Component
Chromatographic
Profile

Macroscopy &
Microscopy

Ash Value
Extractive Value

Authentication and Standardization of Herbal Raw Material

Standardization of Herbal Ayurvedic Drugs

For Global Competitiveness:

Process

Raw materials
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

Product

Organolepthic

Chromatographic fingerprint

. 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
(PD)

-> UNPROCESSED PLANT PARTS AS DRUGS

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.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Botanical Name

Sanskrit Name

Asparagus racemosus Willd Rhizome

Emblica officinalis Gaertn. Dried fruit
Terminalia arjuna W and A stem bark
Tinospora cordifolia (Willd.) Miers. stem
Bacopa monnieri (Linn.) Wettst., whole plant
Terminalia chebula Retz. fruit
Haritaki
Withania somnifera (Linn) Dunal. Root
Azadirachta indica A. Juss., leaf
Rubia cordifolia Linn., root
Eclipta alba. Hassk, whole plant

Shatavari
Amalaki dried fruit
Arjuna
Guduchi
Brahmi (Jal brahmi)
Asvagandha
Nimba
Manjishta
Bhrngaraja
contd

Ayurvedic Drugs Undertaken by

British Pharmacopoeia Commission
Sl.
No.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

Botanical Name

Sanskrit Name

Santalum album Linn., heartwood

Piper longum Linn., fruit and root
Terminalia belerica. Roxb. Fruit
Tribulus terrestris
Convolvulus pluricaulis
Embelia ribes Burm. F., fruit
Phyllanthus niruri
Valeriana wallichi DC, rhizome
Celastrus paniculatus-seeds
Gymnema sylvestre, leaf

Svetacandana
Pippali/Pippalimoola
Bibhitaki
Gokshura
Sankaspuspi
Vidanga
Bhumiamla
Tagara
Jyotismati
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.
2.
3.
4.

5.
6.

To develop SOPs of manufacturing process of formulation

To develop standards of identity, purity and strength of
ingredients & compound formulation
Pharmacognostic & chemical standardization Shelf life
studies
Fifteen Laboratories & manufacturing companies are
working on SOPs
Pharmacopoeial Standards of 100 formulation have been
worked out.
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 MEDICINE

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.

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 (Rule161)

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 (Rule161)

5.
6.
7.
8.
9.
10.

Correct statement of weights & measures

Name and address of the Manufacturer
Manufacturing License Number.
Batch Number.
Date of Manufacturing & Expiry Date
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.
2.
3.
4.
5.
6.
7.
8.

CCRAS- Central Council for Research in Ayurveda

& Siddha
ICMR-Indian Council for Medical Research
CSIR- Council for Scientific & Industrial Research
DST Department of Science & Technology
DBT Department of Bio-technology
No. of Allopathic Medical Colleges
BHU, AIIMS, NIMHANS
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