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Infrastructure & RegulatoryAspect of
Ayurvedic, Siddha & UnaniIndian Traditional
Medicines in India
.
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TRADITIONAL HEALTH KNOWLEDGESYSTEM OF INDIA
* Rich biodiversity,one of the Richest
medicinal plants flora
* Long history of traditional use ofmedicinal plants & health practices
e.g., Ayurveda (5,000 B.C.)
* Codified documented systems likeAyurveda, Siddha, Unani & Yoga
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DEPARTMENT OF AYUSH
Following Systems are recognised by the
Government under Indian Systems of
Medicine & Homeopathy
AYURVEDA SIDDHA
UNANI
YOGA NATUROPATHY
HOMOEOPATHY
*Yoga & Naturopathy are drugless therapies.
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INFRASTRUCTURE OF INDIAN SYSTEMS OF
MEDICINE
(a) Number of colleges (i) U.G. = 452
(ii) P.G. = 100
(b) Admission capacity per annum
(i) U.G. level = 23,280
(ii) P.G. level = 2001
(c) Number of registered practitioners = 6,88,802
(d) Number of hospitals = 3,841
(e) Number of beds in hospitals = 65,753
(f) Number of Dispensaries = 20811
(g) Number of Drug Manufacturing Units = 9,832
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SYSTEM-WISE INFRASTRUCTURE FOR INDIAN SYSTEMS
OF MEDICINE
Medical Colleges Registered Pharmacies
Systems Under Post Practitioners Licensed
Graduate Graduate by Drug
Control Authorities
Ayurveda 219 58* 4,30,890 8,386
Unani 36 08 43,108 453
Siddha 06 02 17,097 384
Homoeopathy 185 32 1,97,252 609
Yoga &
Naturopathy 06 455
TOTAL : 452 100 6,88,802 9,832Admission 23,280 2,001
capacity
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CENTRAL INSTITUTIONS OF AYUSH
Research Councils
1. Central Council for Research in Ayurveda and Siddha
(CCRAS)
2. Central Council for Research in Homoeopathy(CCRH)
3. Central Council for Research in Unani (CCRUM)
4. Central Council for Research in Yoga & Naturopathy
(CCRY&N)
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CENTRAL INSTITUTIONS OF AYUSH
National Institutes
National Institute of Ayurveda, Jaipur
National Institute of Homoeopathy, Kolkata National Institute of Siddha, Chennai
National Institute of Unani, Banglore
National Institute of Naturopathy, Pune
MD National Institute of Yoga, New Delhi
National Academy of Ayurveda (RAV)
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STATUTORY REGULATORY BODIES ANDACTS ON AYURVEDA
For education and practice :
Central Council of Indian Medicine for Ayurveda,
Siddha & Unani medicine established through an Act ofParliament in 1970 ( CCIM)
Objectives are to
* Regulate the standards of Education
* Registration of Practitioners*Code of Medical Ethics
For drug regulation :
Indian Drugs & Cosmetics Act & Rules
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COURSES OF STUDY FOR AYURVEDA
1. Graduation *B.A.M.S. 5 -1/2 years
2. Post graduation *M.D./M.S (Ayurveda) 3 years
(16 specialties)
3. Post doctorate Ph.D. (Ayurveda) (Minimum 2 years)
4. Membership Course MRAV 2 years
(Member of
Rashtriya Ayurved Vidyapeeth)
5. Short & Mid term Certificate or 2 months to
Courses Diploma 2 years
Courses recognised by Central Council of Indian Medicine
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Registration of Practitioners
1. Registration with State Boards of AYURVEDA
2. Registration with Central Council (CCIM)
3. Only Institutionally qualified doctors are eligible after 1970
For registration as Ayurveda practitioner
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Course contents of Degree Courses of Ayurveda
(5.5 years)
First professional (1.5 years)Fundamentals of Ayurveda, Anatomy, Physiology, history of medicine,
social and preventive medicine.
Second professional (1.5 years)
Materia medica / Medicinal plants, pharmaceutical, toxicology andjurisprudence.
Third professional (1.5 years)
Gynaecology & Obstetrics, Pediatrics, Internal medicine, surgery, eye &
ENT.
One year internship in hospital
B.A.M.S. Degree course also contains 30% allopathic components.
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DRUG STANDARDIZATION & QUALITY CONTROL
Outline of the presentation
1. Raw material supply and quality
2. Pharmacy education
3. Drug Acts and regulatory issues
4. Pharmacopoeias, Formularies and Quality standards
5. Good Manufacturing Practices & Good Laboratory Practices
6. Essential Drug Lists published
7. Infrastructure & Export of Ayurvedic Products
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Material Source of Ayurvedic Medicines
(i) Plants and their parts = about 1000 Nos.
(ii) Minerals = 58 Nos.(iii)Products of animal and
marine origin = 54 Nos.
*95% ingredients of Ayurvedic products are of
plant origin
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NATIONAL MEDICINAL PLANTS BOARD
National Medicinal Plants Board and 30 State/U.T.Medicinal Plants Boards have been set up to providequality raw material for preparation of drugs by
ensuring: -
(a) Survey and inventorization of medicinal plants,
(b) In-situconservation and ex-situcultivation ofmedicinal plants,
(c) Production of quality planting material,
Contd.
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NATIONAL MEDICINAL PLANTS BOARD
contd.
(d)Creating and developing infrastructure for thepurpose of value addition, storage & packing ofdrugs conforming to international standards,
(e) Research & Development in medicinal plants sector,
(f) Scientific, technological and economic research onmedicinal plants,
(g)Develop proper harvesting techniques, semi-processing of produces viz., collection, grading,drying, storage, packing etc.
(h)Priority Plants List - 60 Nos.
(i) Area under ex-situ cultivation - 25,000 hectares
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PHARMACY EDUCATION IN AYURVEDA
1. Five and half year B.A.M.S. course contains, 1 year
programme on Dravyaguna & Ras Shastrai.e., Medicinal
Plants, Materia Medica, Pharmaceuticals/ Drug
Manufacturing etc. which is essential for all ISM doctors
2. M.D.(Ayu.) Dravyaguna (Medicinal Plants), Ras Shastra,
Bhaishajya Kalpana (Ayu. Pharmacy)
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PHARMACY EDUCATION IN AYURVEDA contd.
1. 2 years Diploma Course (D. Pharma) Ayurved at Gujarat Ayurved
University, Jamnagar
2. 4 year Degree Course (B. Pharmacy) Ayu. at Gujarat Ayurved
University
3. M. Pharma (Ayu.) at Gujarat Ayurved University
4. M.Sc./M.S. (Traditional Medicine Pharmaceuticals) at National
Institute of Pharmaceutical Education & Research, Mohali Pharmacy
Council for ISM is under consideration by an act of Parliament
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QUALITY CONTROL OF AYURVEDIC DRUGS
Indian Drugs & Cosmetics Act & Rules there under -
Drugs & Cosmetics Act and Drugs & Cosmetics Rules
Chapter (IVA) deals with Ayurvedic medicines. Section 33-C
refers to ASUDTABAyurveda-Siddha-Unani Drug Technical Advisory Board
under Drugs & Cosmetics Act, for Indian Systems of
Medicines to advise Government on all aspects related to
quality control and drug standardisationAyurveda-Siddha-Unani Drugs Consultative Committee
comprising State Drugs Licensing Authorities set up under
the Act for securing uniformity in the administration of the
Act throughout India
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IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS
ACT
* Regulation of manufacture for sale of Ayurvedic
drugs through drug manufacturing licence
system.
* Prohibition of manufacture and sale of certaindrugs.
* 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...
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IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS
ACT RELATING TO AYURVEDIC MEDICINES
* Penalty for manufacture, sale etc., of drugs incontravention of the Act.
* 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 ofpoisonous material used in ASU drugs
require special safeguards
contd.
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IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS
ACT RELATING TO AYURVEDIC MEDICINEScontd..
- Describe misbranded, adulterated and spurious drugs
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)
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PHARMACOPOEIAL & 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. 21 State Drug Testing Laboratories for Ayurvedic
drugs supported in states
3. University/Council for Scientific & Industrial Reseachand other National Laboratories are
associated for pharmacopoeial work
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AYURVEDIC & SIDDHA
PHARMACOPOEIA COMMITTEES
Ayurvedicand SiddhaPharmacopoeia
Committees for evolving different
Pharmacopoeial Standards
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PHARMACOPOEIA AND FORMULARIES:
1. Ayurvedic Pharmacopoeia of India
4 volumes(326 drugs). Volume V containing another
100 monographs is under publication
2. Ayurvedic Formulary of India 2 volumes
(636 formulations)3. National Siddha Formulary of India 1 volume
(248 formulations)
4. Unani Pharmacopoeia of India 1 volume
(45 drugs)5. National Unani Formulary of India 3 volumes
(746 formulations)
6. Homeopathy Pharmacopoeia of India & Codex (9 Volumes)
G M P FOR
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G.M.P. FORAYURVEDA, SIDDHA & UNANI 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.
State Licensing Authorities are constantly pursued to
implement G.M.P.
Infrastructure of factories
Storage of raw material
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G.M.P. FOR AYURVEDIC MEDICINES:
Manufacturing area, machines & processing
Record keeping
In-house quality control & quality assurance
Finished goods store
Working conditions of all sections
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AYURVEDIC ESSENTIAL DRUG LISTS
Essential Drug List of Classical Ayurvedic Drugs
Published
Funds for State Governments to Procure Essential
Drugs for Government Dispensaries.
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SCHEMES TO STRENGTHEN THE SECTOR OF
DRUG STANDARDIZATION & QUALITY CONTROL:
1 Developing of pharmacopoeial standards, SOPs of
manufacturing process and shelf life studies of Ayurvedic
Medicines
2.Strengthening of 21 State Testing Laboratories
3.Strengthening of 40 Drug Manufacturing units
4. Strengthening of Enforcement Mechanism & Drug Controllersof the States
5. Support to private manufactured units for compliance of GMP
and to Support to R&D on Drug Development.
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Infrastructure of Ayurvedic, Siddha and Unani
Pharmaceuticals in 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$1200 millions (Rs. 5000 crores)
-Export worth US$ 200 millions (Rs.1000 crores)
-This does not include the medicines prepared by Ayurvedic doctors fordispensing to their own patients
* Manufacturing Units:
Ayurveda (8386), Unani (453), Siddha (384) & Homeo (609). Total (9,832)
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Ayurvedic Products Herbal Products
1. Based on sound fundamental 1. Imperical and
principles, well documented Experimental base
2. Time tested on human beings 2. Products based on in-vivo
for safety & efficacy and in-vitro trials3. Based on wholesome 3. Isolated or extracted
ingredients material is used
4. Simple procedures of 4. Sophisticated procedures
processing and for new molecules
manufacturing
5. Holistic and comprehensive 5. Generalized or impirical use
approach of use for health
Contd
NEED OF DIFFERENTIATION BETWEEN
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Ayurvedic Products Vs. Herbal Products
6. The product is developed and 6. The product is developed
tested in the manner and tested on the
it is used basis of analytical
parameters
7. Psychophysical 7. No such consideration,
characteristics of fragmented approach
patients are taken of treatmentinto consideration,
hence holistic
approach
NEED OF DIFFERENTIATION BETWEEN
contd.
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1. Official - name of the drug - (Sanskrit/Tamil/Arabic)
2. General Introduction:
3. Synonyms e.g., Regional names etc.
4. Description :
(a) Macroscopic, description
(b) Microscopic (Pharmacognostic), description
- Root
- Stem
- Leaf
- Flower
- Fruit
- Seed
5. Powder - diagnostic features
6. Chemical constituents ..Contd
Pharmacopoeial Standards of ASU Drugs
Reference : Pharmacopoeia of India(API)
Monograph
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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)
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.
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Pharmacopoeial Standards of ASU Drugs
Reference : Pharmacopoeia of India(API)
Monograph ..contd.
Important Formulations: ----
Therapeutic Uses: ----
Dose: ----
Authentic/Textual Refences ----
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Pharmacopoeial Standards of ASU DrugsRef. : Ayurveda Pharmacopoeia of India(API)
Monograph ..contd.
Additional Quality Standards
Microbial load
Heavy metals
Pesticide residue
Safety profile ( Toxicity)
Efficacy
DOSAGE FORMS OF ASU FORMULATIONS
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DOSAGE FORMS OF ASU FORMULATIONS
Sl.No. Dosage Form No. of ingredients Dose
1. Swarasa (Expressed Juice) 1-3 5-10 ml.
2. Churna (Powder of the combination) 3-20 3-5 gm.3. Kwath Churna (Coarse power for 3-15 10-30 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.
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)
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DOSAGE FORMS OF ASU FORMULATIONS
Sl.No. Dosage Form No. of ingredients Dose
11. Taila (Medicated/oil based 10-20 External
formulations)
12. Lepa (For external applications) 5-15 External
13. Malhara (Ointment) 3-5 External
14. Satva/Ghansatva - 1-3 1/2 - 1 gm.total water extract
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
19. Karn bindu (Ear drops) 5-1020. Nasaya (Nasal drops/ 5-10
insulation)
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DOSAGE FORMS OF ASU FORMULATIONS
(multiple ingredients) (Contd.)
Sl.No. Dosage Form No. of ingredients Single dose
21. Bhasma - (Calcinated ash); 1-3 50-100 mg.
(i) Mineral based ash;
(ii)Metal based ash
22. Lauh & Mandora - 5-20 1gm.(Iron ash based formulations);
23. Ras Yoga -
(i) Kupipakva 2-5 50-100 mg.
Rasayan & Parpati -
Meallic compounds 2-5 30-60 mg.(ii) Rasayoga - Herbo-mineral 5-20 125-250 mg.
-metalic formulations
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- Published Pharmacopoeial standards of A.S.U. drugs- Enforcement of GMP
- Schedule E of the Drugs and Cosmetics Act provides list of
poisonous materials
- Licensing for drug manufacturers- Ayurvedic Formulary of drugs published
- Essential Drug Lists published
- Punitive action provided in the Act for misbranded,
adulterated and spurious drugs
- Schemes to provide financial assistance for strengthening of
infrastructure, functional capacity of pharmacies & drug
testing laboratories implemented
Measures Taken by Government of Indiafor Ensuring Quality and Safety of Drugs
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