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Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Indian Traditional Medicines in India

Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Indian Traditional Medicines in India. . TRADITIONAL HEALTH KNOWLEDGE SYSTEM OF INDIA * Rich biodiversity,one of the Richest medicinal plants flora

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Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Indian Traditional Medicines in India

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  1. Infrastructure & Regulatory Aspect of Ayurvedic, Siddha & Unani Indian Traditional Medicines in India .

  2. TRADITIONAL HEALTH KNOWLEDGE SYSTEM OF INDIA * Rich biodiversity,one of the Richest medicinal plants flora *     Long history of traditional use of medicinal plants  & health practices e.g., Ayurveda (5,000 B.C.) * Codified documented systems like Ayurveda, Siddha, Unani & Yoga

  3. 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. 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. SYSTEM-WISE INFRASTRUCTURE FOR INDIAN SYSTEMS OF MEDICINE Medical CollegesRegisteredPharmacies SystemsUnderPostPractitionersLicensed GraduateGraduateby 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 9,832 Admission 23,280 2,001 capacity

  6. CENTRAL INSTITUTIONS OF AYUSH • Research Councils • Central Council for Research in Ayurveda and Siddha (CCRAS) • Central Council for Research in Homoeopathy(CCRH) • Central Council for Research in Unani (CCRUM) • Central Council for Research in Yoga & Naturopathy (CCRY&N)

  7. 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. STATUTORY REGULATORY BODIES AND ACTS ON AYURVEDA For education and practice : Central Council of Indian Medicine for Ayurveda, Siddha & Unani medicine established through an Act of Parliament 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. COURSES OF STUDY FOR AYURVEDA • Graduation *B.A.M.S. 5 -1/2 years • Post graduation *M.D./M.S (Ayurveda) 3 years (16 specialties) • Post doctorate Ph.D. (Ayurveda) (Minimum 2 years) • Membership Course MRAV 2 years (Member of Rashtriya Ayurved Vidyapeeth) • Short & Mid term Certificate or 2 months to Courses Diploma 2 years • Courses recognised by Central Council of Indian Medicine

  10. Registration of Practitioners 1. Registration with State Boards of AYURVEDA2. Registration with Central Council (CCIM)3. Only Institutionally qualified doctors are eligible after 1970 For registration as Ayurveda practitioner

  11. 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 and jurisprudence.Third professional (1.5 years) Gynaecology & Obstetrics, Pediatrics, Internal medicine, surgery, eye & ENT.One year internship in hospitalB.A.M.S. Degree course also contains 30% allopathic components.

  12. DRUG STANDARDIZATION & QUALITY CONTROL • Outline of the presentation • Raw material supply and quality • Pharmacy education • Drug Acts and regulatory issues • Pharmacopoeias, Formularies and Quality standards • Good Manufacturing Practices & Good Laboratory Practices • Essential Drug Lists published • Infrastructure & Export of Ayurvedic Products

  13. Material Source of Ayurvedic Medicines • Plants and their parts = about 1000 Nos. • Minerals = 58 Nos. • Products of animal and • marine origin = 54 Nos. • *95% ingredients of Ayurvedic products are of • plant origin

  14. NATIONAL MEDICINAL PLANTS BOARD National Medicinal Plants Board and 30 State/U.T. Medicinal Plants Boards have been set up to provide quality raw material for preparation of drugs by ensuring: - (a) Survey and inventorization of medicinal plants, (b) In-situ conservation and ex-situ cultivation of medicinal plants, (c) Production of quality planting material, Contd….

  15. NATIONAL MEDICINAL PLANTS BOARD • contd…. • Creating and developing infrastructure for the purpose of value addition, storage & packing of drugs conforming to international standards, • Research & Development in medicinal plants sector, • Scientific, technological and economic research on medicinal plants, • Develop proper harvesting techniques, semi-processing of produces viz., collection, grading, drying, storage, packing etc. • Priority Plants List - 60 Nos. • Area under ex-situ cultivation - 25,000 hectares

  16. PHARMACY EDUCATION IN AYURVEDA 1. Five and half year B.A.M.S. course contains, 1 ½ year programme on Dravyaguna & Ras Shastra i.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. PHARMACY EDUCATION IN AYURVEDA contd…. • 2 years Diploma Course (D. Pharma) Ayurved at Gujarat Ayurved University, Jamnagar • 4 year Degree Course (B. Pharmacy) Ayu. at Gujarat Ayurved University • M. Pharma (Ayu.) at Gujarat Ayurved University • 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. 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 ASUDTAB • Ayurveda-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 standardisation • Ayurveda-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. 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 certain drugs. • * Power of Central Government to prohibitmanufacture etc. of drugs in public interest. • * Provision for Government Drug Analysts. • * Provision for Inspectors to visit factory. • contd...

  20. IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS ACT RELATING TO AYURVEDIC MEDICINES • * Penalty for manufacture, sale etc., of drugs in contravention 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 of •   poisonous material used in ASU drugs • require special safeguards • contd….

  21. IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS ACT RELATING TO AYURVEDIC MEDICINES contd….. • - 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. PHARMACOPOEIAL & TESTING FACILITIES FORAYURVEDIC 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 Reseach and other National Laboratories are associated for pharmacopoeial work

  23. AYURVEDIC & SIDDHA PHARMACOPOEIA COMMITTEES ·Ayurvedicand SiddhaPharmacopoeia Committees for evolving different Pharmacopoeial Standards

  24. 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)

  25. G.M.P. FOR • AYURVEDA, 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. 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. AYURVEDIC ESSENTIAL DRUG LISTS • Essential Drug List of Classical Ayurvedic Drugs Published • Funds for State Governments to Procure Essential Drugs for Government Dispensaries.

  28. 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 Controllers • of the States • 5. Support to private manufactured units for compliance of GMP and to Support to R&D on Drug Development.

  29. 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 for dispensing to their own patients * Manufacturing Units: Ayurveda (8386), Unani (453), Siddha (384) & Homeo (609). Total (9,832)

  30. NEED OF DIFFERENTIATION BETWEEN Ayurvedic ProductsHerbal 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 trials 3. 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…

  31. NEED OF DIFFERENTIATION BETWEEN contd…. 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 treatment into consideration, hence holistic approach

  32. Pharmacopoeial Standards of ASU Drugs Reference : Pharmacopoeia of India(API) Monograph 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……

  33. 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) Properties and Action: (i) Rasa (Taste) (ii) Guna (Properties) (iii) Virya (Predominant action) (iv) Vipaka (Metabolic action) (v) Karma (Pharmacological action)

  34. Pharmacopoeial Standards of ASU Drugs Reference : Pharmacopoeia of India(API) Monograph …..contd. Important Formulations: ---- Therapeutic Uses: ---- Dose: ---- Authentic/Textual Refences ----

  35. 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

  36. Sl.No. Dosage FormNo. of ingredientsDose 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) DOSAGE FORMS OF ASU FORMULATIONS

  37. Sl.No. Dosage FormNo. of ingredientsDose 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) 5-10 20. Nasaya (Nasal drops/ 5-10 insulation) DOSAGE FORMS OF ASU FORMULATIONS

  38. DOSAGE FORMS OF ASU FORMULATIONS (multiple ingredients) (Contd…….) Sl.No. Dosage FormNo. of ingredientsSingle 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. Measures Taken by Government of India for Ensuring Quality and Safety of Drugs 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

  40. THANKS

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