Transcript Document

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 : [email protected]
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.
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
-
Siddha Medicine has also a long history of origin B.C.
-
Unani Medicine started in Greece in B.C. era
INFRASTRUCTURE
•
•
•
•
Registered Practitioners:
Teaching institutions:
Postgraduate institutions:
Universities:
• Annual admission capacity
for degree courses
• Annual admission capacity for
Postgraduate courses:
• Hospitals:
• Hospital bed capacity:
• Dispensaries:
• Drug manufacturing units:
6,95,024
466
103
6 Health Universities and
2 Ayurveda Universities.
23,555
1,888
3,100
66,366
20,811
9,257
SYSTEM-WISE INFRASTRUCTURE FOR INDIAN SYSTEMS
OF MEDICINE
Medical Colleges
Systems
Under
Graduate
Registered
Post
Graduate
Practitioners
Control
Pharmacies
Licensed
by Drug
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
TOTAL :
Admission
capacity
06
455
466
103
23,280
2,001
6,88,802
9,832
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)
Central Council for Research in
Homoeopathy (CCRH)
Central Council for Research in
Unani Medicine (CCRUM)
Central Council for Research in
Yoga & Naturopathy (CCRYN)
-39 Units
-40 Units
-25 Units
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
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.
8.
9.
10.
11.
12.
13.
Dosage Form
No. of ingredients
Paka Khand (Confectionary
like formulation)
Guggulu (Guggulu base formulation
in tab./pill form)
Ghrita (Classified butter based
formulations)
Taila (Medicated/oil based
formulations)
Lepa (For external applications)
Malhara (Ointment)
Dose
10-25
5-10 gm.
5-20
1-3 gm.
5-20
5-10 gm.
10-20
External
5-15
3-5
External
External
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
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
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
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)
44
Pharmacopoeial Standards of Ayurvedic Drugs
Reference : Pharmacopoeia of India (API) Monograph
1.
Official - name of the drug - Sanskrit/Ayurvedic)
2.
3.
General Introduction:
Synonyms e.g., Regional names etc.
4.
(a)
(b)
Description :
Macroscopic, description
Microscopic (Pharmacognostic), description
- Root
5.
-Flower
- Stem
-Fruit
- Leaf
-Seed
Powder - diagnostic features
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)
(ii)
(iii)
(iv)
(v)
Rasa (Taste)
Guna (Properties)
Virya (Predominant action)
Vipaka (Metabolic action)
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, 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…
Sl.
No.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Ayurvedic Drugs Undertaken by
British Pharmacopoeia
Commission
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 SOP’s 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 SOP’s
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.
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.
2.
3.
4.
Name of formulation
True list of ingredients used in the formulation
together with the quantity of each ingredient
If the list is long a separate list be enclosed with
the packing and reference be made on the label.
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.
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
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
• Private drug manufacturing units about
• Government Drug testing laboratories
• -State licensing authorities & Drug controllers
• -Domestic market of Ayurvedic, Siddha &
Unani Medicines is worth
millions
• -Export worth
=
=
=
=
40
9,832
21
23
US $1400
(Rs. 6000 crores)
US$ 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) &
Total
=
(9,832)
Homeo (609).
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