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Country Paper- International Conclave 2006 INFRASTRUCTURE STATUS, REGULATION & QUALITY CONTROL OF INDIAN MEDICINE

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,

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Country Paper- International Conclave 2006 INFRASTRUCTURE STATUS, REGULATION & QUALITY CONTROL OF INDIAN MEDICINE

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  1. Country Paper- International Conclave 2006INFRASTRUCTURE 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 : adv_ayurveda@yahoo.com

  2. 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.

  3. OFFICIALLY RECOGNIZED SYSTEMS • Ayurveda * Yoga * Naturopathy • Unani • Siddha • Homeopathy * Yoga & Naturopahty are drugless therapies. * Homoeopathy is of German origin.

  4. 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

  5. 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

  6. SYSTEM-WISE INFRASTRUCTURE FOR INDIAN SYSTEMS OF MEDICINE Medical CollegesRegisteredPharmacies SystemsUnderPostPractitionersLicensed GraduateGraduateby 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

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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)

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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

  25. Concept of Shodhana of a Drug (Purification & Detoxification of the Raw Drugs) Objects to ensure Safety: • To remove the un desirous effect of raw drugs. • To remove the toxic effect of raw drug • To make the drug suitable as medicine • The purification is done by various processes of mixing, boiling of the raw drug with other substances with specific properties, Drying etc.

  26. Sl. No. Dosage FormNo. of ingredientsDose 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 (Multiple Ingredients)

  27. Sl.No. Dosage FormNo. of ingredientsDose 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 DOSAGE FORMS OF AYURVEDIC FORMULATIONS

  28. DOSAGE FORMS OF AYURVEDIC FORMULATIONS (multiple ingredients) contd. Sl.No. Dosage FormNo. of Single ingredientsdose 14. 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

  29. DOSAGE FORMS OF AYURVEDIC FORMULATIONS(multiple ingredients) contd. Sl.No. Dosage FormNo. of SingleIngredientsdose 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

  30. Authentication Heavy Metal Contaminants Foreign Matter STANDARDIZATION OF AYURVEDA DRUGS Organoleptic Evaluation Microbial Count Macroscopy & Microscopy Pesticide Residue Volatile Matter Marker Component Chromatographic Profile Ash Value Extractive Value Authentication and Standardization of Herbal Raw Material

  31. Standardization of Herbal Ayurvedic Drugs For Global Competitiveness: Process Raw materials • 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 Product • Organolepthic . Physico chemical properties • Chromatographic fingerprint • Assay [Chemical / biological] • Storage stability • User safety • Packaging and labelling

  32. 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

  33. 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

  34. 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)

  35. Pharmacopoeial Standards of Ayurvedic Drugs Reference : Pharmacopoeia of India (API)Monograph 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

  36. 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) Rasa (Taste) (ii) Guna (Properties) (iii) Virya (Predominant action) (iv) Vipaka (Metabolic action) (v) Karma (Pharmacological action)

  37. 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 -----

  38. 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

  39. Ayurvedic, Siddha & Unani Drugs Undertaken by British Pharmacopoeia Commission Sl. Botanical Name Sanskrit Name No. • Asparagus racemosus Willd Rhizome Shatavari • Emblica officinalis Gaertn. Dried fruit Amalaki dried fruit • Terminalia arjuna W and A stem bark Arjuna • Tinospora cordifolia (Willd.) Miers. stem Guduchi • Bacopa monnieri (Linn.) Wettst., whole plant Brahmi (Jal brahmi) • Terminalia chebula Retz. fruit Haritaki • Withania somnifera (Linn) Dunal. Root Asvagandha • Azadirachta indica A. Juss., leaf Nimba • Rubia cordifolia Linn., root Manjishta • Eclipta alba. Hassk, whole plant Bhrngaraja contd…

  40. Ayurvedic Drugs Undertaken by British Pharmacopoeia Commission Sl. Botanical Name Sanskrit Name No. • Santalum album Linn., heartwood Svetacandana • Piper longum Linn., fruit and root Pippali/Pippalimoola • Terminalia belerica. Roxb. Fruit Bibhitaki • Tribulus terrestris Gokshura • Convolvulus pluricaulis Sankaspuspi • Embelia ribes Burm. F., fruit Vidanga • Phyllanthus niruri Bhumiamla • Valeriana wallichi DC, rhizome Tagara • Celastrus paniculatus-seeds Jyotismati • Gymnema sylvestre, leaf Gurmar/Meshasringi

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