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.inTelefax : 011-23328576

E-mail : adv_ayurveda@yahoo.com

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.

OFFICIALLY RECOGNIZED SYSTEMS

• Ayurveda

* Yoga

* Naturopathy • Unani• Siddha• Homeopathy

* Yoga & Naturopahty are drugless therapies.

* Homoeopathy is of German origin.

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

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

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

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.

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

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.

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

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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

Sl.No. Dosage Form No. of Single ingredients

dose14. 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.

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

STANDARDIZATION OF AYURVEDA DRUGS

AuthenticationAuthentication

Heavy Metal ContaminantsHeavy Metal

Contaminants

Microbial CountMicrobial Count

Pesticide Residue

Pesticide Residue

Marker Component

Marker Component

Chromatographic Profile

Chromatographic Profile

Extractive ValueExtractive Value

Ash ValueAsh Value

Volatile MatterVolatile Matter

Macroscopy & Microscopy

Macroscopy & Microscopy

Organoleptic Evaluation

Organoleptic Evaluation

Foreign MatterForeign Matter

Authentication and Standardization of Herbal Raw Material

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

Packaging and labelling

For Global Competitiveness:

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)

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

PHARMACOPOEIAL MONOGRAPHS ON AYURVEDIC DRUGS AND

FORMULATIONS

AIMS

CONTROL OF PRODUCT QUALITY IN TERMS OF:IdentityPurityStrength

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

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

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 DrugsReference : Pharmacopoeia of India(API) Monograph

…..contd.

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…

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

Ayurvedic, Siddha & Unani Drugs Undertaken by

British Pharmacopoeia Commission

Sl. Botanical Name Sanskrit NameNo.1. Asparagus racemosus Willd Rhizome Shatavari2. Emblica officinalis Gaertn. Dried fruit Amalaki dried fruit3. Terminalia arjuna W and A stem bark Arjuna4. Tinospora cordifolia (Willd.) Miers. stem Guduchi5. 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 Nimba9. Rubia cordifolia Linn., root Manjishta10. Eclipta alba. Hassk, whole plant Bhrngaraja

contd…

Ayurvedic Drugs Undertaken by British Pharmacopoeia

CommissionSl. Botanical Name Sanskrit NameNo.11. Santalum album Linn., heartwood Svetacandana 12. Piper longum Linn., fruit and root Pippali/Pippalimoola13. Terminalia belerica. Roxb. Fruit Bibhitaki14. Tribulus terrestris Gokshura15. Convolvulus pluricaulis Sankaspuspi16. Embelia ribes Burm. F., fruit Vidanga17. Phyllanthus niruri Bhumiamla18. Valeriana wallichi DC, rhizome Tagara19. Celastrus paniculatus-seeds Jyotismati20. 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 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.

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.

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

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     

G.M.P. FOR AYURVEDIC MEDICINES:

On GMP for Ayurveda/Siddha/Unani DrugsOn 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

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.

* 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

* 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

- 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…..

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…

5. Correct statement of weights & measures 6. Name and address of the Manufacturer7. Manufacturing License Number.8. Batch Number.9. Date of Manufacturing & Expiry Date10. 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)

Research in Ayurveda

1. CCRAS- Central Council for Research in Ayurveda & Siddha

2. ICMR-Indian Council for Medical Research3. CSIR- Council for Scientific & Industrial Research4. DST – Department of Science & Technology5. DBT – Department of Bio-technology6. No. of Allopathic Medical Colleges7. BHU, AIIMS, NIMHANS8. 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

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.

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.

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)

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.

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.

THANKS