regulatory india lave kar

7/31/2019 Regulatory India Lave Kar

1/40

Infrastructure & RegulatoryAspect of

Ayurvedic, Siddha & UnaniIndian Traditional

Medicines in India

.


2/40

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


3/40

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.


4/40

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


5/40

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


6/40

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)


7/40

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)


8/40

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


9/40

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


10/40

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


11/40

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.


12/40

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


13/40

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


14/40

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.


15/40

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


16/40

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)


17/40

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


18/40

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


19/40

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...


20/40


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.


21/40


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)


22/40

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


23/40

AYURVEDIC & SIDDHA

PHARMACOPOEIA COMMITTEES

Ayurvedicand SiddhaPharmacopoeia

Committees for evolving different

Pharmacopoeial Standards


24/40

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


25/40

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


26/40

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


27/40

AYURVEDIC ESSENTIAL DRUG LISTS

Essential Drug List of Classical Ayurvedic Drugs

Published

Funds for State Governments to Procure Essential

Drugs for Government Dispensaries.


28/40

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.


29/40

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)


30/40

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


31/40

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.


32/40

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


33/40

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


Monograph ..contd.


34/40

Pharmacopoeial Standards of ASU Drugs


Monograph ..contd.

Important Formulations: ----

Therapeutic Uses: ----

Dose: ----

Authentic/Textual Refences ----


35/40

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


36/40


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)


37/40


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)


38/40


(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


39/40

- 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


40/40

regulatory india lave kar

Documents