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1. Country Paper- International Conclave 2006
INFRASTRUCTURE STATUS, REGULATION &
QUALITY CONTROL OF INDIAN MEDICINE
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
www.indianmedicine.nic.in
Telefax : 011-23328576
E-mail : adv_ayurveda@yahoo.com

2. TRADITIONAL INDIAN HEALTH KNOWLEDGE
• Rich bio-diversity of India.
• 12 agro-climatic zones.
• Wide range of medicinal plant species.
• Long history of use of medicinal plants
and health practices (Ayurveda 5000
BC).
• Codified, organized, documented and
officially recognized health systems
• Ayurveda-Siddha-Unani & Yoga.

3. OFFICIALLY RECOGNIZED SYSTEMS
• Ayurveda
* Yoga
* Naturopathy
• Unani
• Siddha
• Homeopathy
* Yoga & Naturopahty are drugless therapies.
* Homoeopathy is of German origin.

4. 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
- Siddha Medicine has also a long history of origin B.C.
- Unani Medicine started in Greece in B.C. era
ANTIQUITY OF AYURVEDA

5. INFRASTRUCTURE
• Registered Practitioners: 6,95,024
• Teaching institutions: 466
• Postgraduate institutions: 103
• Universities: 6 Health Universities and
2 Ayurveda Universities.
• Annual admission capacity 23,555
for degree courses
• Annual admission capacity for 1,888
Postgraduate courses:
• Hospitals: 3,100
• Hospital bed capacity: 66,366
• Dispensaries: 20,811
• Drug manufacturing units: 9,257

6. SYSTEM-WISE INFRASTRUCTURE FOR INDIAN SYSTEMS
OF MEDICINE
Medical Colleges Registered Pharmacies
Systems Under Post Practitioners Licensed
Graduate Graduate by Drug
Control Authorities
Ayurveda 232 60 4,30,890 8,386
Unani 38 08 43,108 453
Siddha 06 02+1 N.Instt. 17,097 384
Homoeopathy 185 32 1,97,252 609
Yoga &
Naturopathy 06 455
TOTAL : 466 103 6,88,802 9,832
Admission 23,280 2,001
capacity

7. ORGANISATIONAL SET UP
(Central Level)
• Central Department under Ministry of Health
& Family Welfare.Govt of India
• Central Research Councils.
• Central Regulatory Bodies.
• National Institutes.
• National Medicinal Plant Board.
• Central Pharmacopoeia Laboratories.
• Manufacturing Unit.
• Hospitals & dispensaries.

8. ORGANISATIONAL SET UP
(State level)
• AYUSH Department or Ministry.
• State Directorates
• State Boards/Councils for registration of
practitioners.
• State Licensing/Drug Control Authorities.
• State colleges/institutions.
• State Pharmacies
• State Drug Testing Laboratories.
• State Medicinal Plant Boards

9. POLICY SUPPORT
• Independent Policy for AYUSH -2002.
• Systems enjoy Government support since
independence.
• Health Policy-1983 envisaged integrated
role of AYUSH in health delivery.
• National Population Policy provides for
utilization of AYUSH practitioners in
population stabilization Programmes.
• National policy in conformity with WHO
strategy for traditional medicine.

10. NATIONAL INSTITUTES
 National Institute of Ayurveda, Jaipur
 Institute of Postgraduate Training &
Research in Ayurveda, Gujarat Ayurveda
University Jamnagar.
 National Institute of Unani Medicine,
Bangalore
 National Institute of Naturopathy, Pune
 Morarji Desai National Institute of Yoga,
New Delhi
 National Institute of Siddha, Chennai
 National Academy of Ayurveda, New Delhi
 National Institute of Homoeopathy, Calcutta
 *All India Institute of Ayurveda, New Delhi

11. CENTRAL RESEARCH COUNCILS
• Central Council for Research in
Ayurveda & Siddha(CCRAS) -39 Units
Central Council for Research in
Homoeopathy (CCRH) -40 Units
Central Council for Research in
Unani Medicine (CCRUM) -25 Units
Central Council for Research in
Yoga & Naturopathy (CCRYN)

12. COURSES OF STUDY
• Degree course – BAMS/BUMS/BSMS/BHMS
• Postgraduate course –M.D. (Ayu)/S/U/H
• Post doctorate course- Ph. D.
• Membership course of National Ayurveda
Academy.
• Short & mid term courses.
• Diploma, degree and postgraduate courses
for Pharmacy education.

13. MATERIAL SOURCE OF
MEDICINAL RAW MATERIALS
• 95% raw materials of plant origin.
• About 1,000 medicinal plants commonly
used.
• 58 different types of metals and minerals.
• 54 products of animal and marine origin.

14. NATIONAL MEDICINAL PLANT
BOARD & STATE BOARDS
• Cultivation & conservation of medicinal plants.
• Supply of quality raw and planting materials.
• Assessment of demand & supply position.
• Standardization & quality control of medicinal
plants.
• Scientific, technological and economic research
on medicinal plants.
• Development of agro-technology and harvesting,
semi-processing and value addition techniques.
• Trade and export of medicinal plant products.

15. REGULATORY LAWS
• Indian Medicine Central Council Act,
1970.
• Drugs & Cosmetics Act, 1940
• Drugs & Magic Remedies
(Objectionable Advertisements) Act
• Bio-diversity Act.
• Wild Life Protection Act.
• Indian Forests Act.

16. LAW FOR EDUCATION FOR AYURVEDA,
SIDDHA & UNANI
I.M.C.C. ACT 1970
• Central Government is vested with powers to
grant permission for opening of new
colleges, increase of admission capacity and
starting of new or higher courses of study.
• Central Government grants permission on
the basis of recommendations of State
Government, affiliating university and
regulatory council and availability of
infrastructure as per prescribed norms.

17. LAW FOR PRACTICE
I.M.C.C. ACT 1970
• Registration of practitioners mandatory.
• Registration requires possession of
recognized qualification.
• Qualifications awarded by universities are
included in the Act with the approval of
Central Government.

18. LAW FOR REGULATION OF DRUGS &
COSMETICS
• Separate chapter and rules for Ayurveda,
Siddha and Unani drugs in Drugs &
Cosmetics Act, 1940.
• Drug Technical Advisory Board for matters
related to quality control and standardization
• Drugs Consultative Committee for securing
uniform administration of the legal
provisions in different states.

19. Contd…
• Licensing of manufacturing units and drugs
mandatory.
• Central Government empowered to prohibit
manufacture and sale of certain drugs in
public interest.
• Government Drug Analysts- Qualifications
and Duties.
• Appointment of Drug inspectors.
• Penalty for manufacture, sale etc. of drugs in
contravention of Act.

20. Contd…
• To prescribe methods of drug testing and
analysis.
• Listing of schedule E drugs –poisonous
materials.
• Definition of misbranded, adulterated and
spurious drugs for punitive action.
• Good Manufacturing Practices (GMP).
• Good Laboratory Practices.
• Labeling/Packing provisions.
• Recognition of private and public drug testing
laboratories for sample analysis.

21. PHARMACOPOEIAL STANDARDIZATION
AND TESTING FACILITIES
• Pharmacopoeial Laboratory for Indian
Medicine (PLIM) established in 1970.
• 24 State Drug Testing Laboratories.
• Laboratories of universities and research
councils.

22. PHARMACOPOEIAL WORK
• Scientific institutions/laboratories
undertake basic work of standardization.
• Experts of Ayurveda, Unani, Siddha
phytochemistry, pharmaceutical science,
pharmacognosy and medicinal plants
remain associated.
• Pharmacopoeia Committee notified by the
Government approves the
pharmacopoeial standards.

23. PHARMACOPOEIA, FORMULARIES
& ESSENTIAL DRUG LISTS
• Ayurvedic Pharmacopoeia: 418 monographs
• Ayurvedic Formulary: 636 formulations
• Unani Pharmacopoeia: 45 monographs
• Unani Formulary: 745 formulations
• Siddha Formulary: 248 formulations
• Essential drug lists published.

24. 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

25. Concept of Shodhana of a Drug
(Purification & Detoxification of the Raw
Drugs)
Objects to ensure Safety:
1. To remove the un desirous effect of raw
drugs.
2. To remove the toxic effect of raw drug
3. To make the 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.

26. 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.

27. 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

28. 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.

29. 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

30. STANDARDIZATION
OF AYURVEDA DRUGS
Authentication
Heavy Metal
Contaminants
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

31. Standardization of Herbal Ayurvedic Drugs
Raw materials
Product
Process
 Material/energy inputs
 Operational uniformity
 Safety and occupational health
 Intermediate quality [in process
quality control
 Chromatographic fingerprint
 Authentication
 Physico, chemical, biological limits
 Storage conditions
 Size/shape/right quality
 Chromatographic fingerprint
 Organolepthic . Physico chemical properties
 Chromatographic fingerprint
 Assay [Chemical / biological]
 Storage stability
 User safety
For Global Competitiveness:

32. 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

33. TLC FINGER-PRINT Sennae folium, fructus
A HNO3-Potassium hydroxide reagent (UV 365 nm)
B Sodium metaperiodate reagent (UV 365 nm)
1 Sennae fructus (methanol ext. 20 uL)
2 Sennae folium (methanol ext. 20 uL)
T1 Sennoside A T2 Sennoside B
Solvent system:- n-propanol : Ethylacetate : Water : gl. acetic acid (40:40:29:1)

44. 44
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)

45. 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
Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India (API) Monograph

46. 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.

47. Test for Heavy Metals -----
Microbial Load -----
Important Formulations: -----
Therapeutic Uses: -----
Dose: -----
Authentic/Textual References -----
Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India(API)
Monograph contd …

48.  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.
AYURVEDIC PHARMACOPOEIA OF INDIA [API]
 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

49. Ayurvedic, Siddha & Unani 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…

50. 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

51. 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

52. Pharmacopoeial Standards of
Multiple Ingredient Ayurvedic
Formulations
1. To develop SOP’s 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 SOP’s
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.

53. 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.

54. 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.

55. 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
PHARMACOPOEIAL LABS &
TESTING FACILITIES FOR
AYURVEDIC DRUGS

56. 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

57. 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
G.M.P. FOR AYURVEDIC MEDICINES:

58. On GMP for Ayurveda/Siddha/Unani Drugs
• GMP certificate is a must if you are going to produce any
Ayurveda products
- Raw Materials-prescribed quality and free from contamination
- Manufacturing process-infrastructure, staff
- QC-adequate measure to be adopted, documents
*Ref: Schedule T, Drugs & Cosmetic Act Notification (June, 2000), ISM & H, Min Health, GOI
GMP Requirements
- 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

59. 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.

60. * 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

61. * 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

62. - 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)
IMPORTANT PROVISIONS OF INDIAN DRUGS &
COSMETICS ACT RELATING TO AYURVEDIC
MEDICINES
contd…..

63. 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)

64. 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..

65. Contd…
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.
Labeling provisions (Rule-161)

66. 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

67. 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

68. QUALITY CONTROL MEASURES
• Publication of Pharmacopoeial standards.
• Publication of Formularies.
• Publication of Essential Drug Lists.
• Enforcement of GMP.
• Scheduled list of poisonous materials.
• Prohibition on misleading & objectionable
advertisements.
• Scientific validation of classical/traditionally used
medicines for safety and efficacy.

69. Contd…..
• Schedule for mandatory licensing of drug
manufacturers.
• Misbranded, spurious and adulterated drugs
defined.
• Legal provision for punitive action for acting in
contravention of Drugs & Cosmetics Act.
• Mandatory testing of exported drugs for heavy
metals.
• Self-certification of quality by manufacturers.
• Financial assistance to manufacturing units and
Drug Testing Laboratories for improving
structural and functional capacity.

70. Infrastructure of Ayurvedic, Siddha and Unani
Pharmaceuticals of India
-Manufacturing units in government and
• - Cooperative sector = 40
• - Private drug manufacturing units about = 9,832
• - Government Drug testing laboratories = 21
• -State licensing authorities & Drug controllers = 23
• -Domestic market of Ayurvedic, Siddha &
Unani Medicines is worth US $1400
millions (Rs. 6000 crores)
• -Export worth US$ 350 millions
(Rs.1500 crores)
• -This does not include the medicines prepared by
Ayurvedic doctors for dispensing to their own patients
• * Manufacturing Units:
• Ayurveda (8386), Unani (453), Siddha (384) & Homeo (609).
Total = (9,832)

71. POSSIBLE AREA OF INTERNATIONAL
CO-OPERATION
• Exchange of experts and strategies on
pharmaceutical technology, databasing &
digitization, pharmacopoeias, formularies,
regulatory mechanism and standardization &
quality control measures.
• Scholarship programme for students of TM
desirous to undergo training at cross country
institutions.
• Import and export of raw materials & finished
TM products as per mutual agreement.
• Survey & Documentation of traditionally used
medicinal plants, remedies and practices.

72. Contd…..
• Training programmes on agro-technology,
manufacturing technology, quality control &
standardization, R&D and collaborative
scientific validation studies on TM.
• To organise bilateral and multilateral
programmes on themes of common interest
for development of TM.
• Formulation of common strategy for
protection of TM against misappropriation and
international market authorization of
Traditional Herbal Medicinal Products.

73. THANKS