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Herbal technology – challenges and opportunities for India – CSIR experience

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Herbal technology – challenges and opportunities for India – CSIR experience

اسلاید 1: www.tabaye.ir

اسلاید 2: Herbal technology – challenges and opportunities for India – CSIR experienceP. PushpangadanNational Botanical Research InstituteRana Pratap Marg, Lucknow-226001

اسلاید 3: 21st Century21st century is the century of Biology powered and propelled by scientific knowledge and technological expertiseThree technologies namely Biotechnology Herbal technology Information technology (Bioinformatics)are going to be the most powerful elements that are crucial for prosperity and welfare for the people of nations.

اسلاید 4: Herbal technologyAll technologies for the manufacture of value added plant products can be called as herbal technologyHerbal drugs and pharmaceuticals,Nutraceuticals,Functional foods, designer foods or health foods and health drinksCosmaceuticalsBiocontrol agentsBiopesticides

اسلاید 5: WORLD TRADE AND ECONOMIES: THE PARADIGM SHIFT“Resource – based economies’ to ‘Knowledge –based economies’ 21 st Century will be the Century of Knowledge”……t“A nation’s ability to convert knowledge in to wealth and social good through the process of innovation will determine its future” ( R A Mashelkar, 2001)

اسلاید 6: Some features of international health careHealth care policies largely market driven by the pharmaceutical industry diverting attention from health preservation to illness curePrevention and eradication of diseases undermines the economic basis of this industryNo satisfactory drugs available for most of the degenerative disorders characteristic of graying population and for re-emerging resistant infectionsMany currently used modern drugs do not have valid proven clinical utility.USA has among the highest per capita annual expenditure on health care ($3600) but still about 15% population is denied even basic care facilities (the best Indian state like Kerala have an annual per capita expenditure ~ $15)

اسلاید 7: Herbal drugs in international health careEconomic aspects: tGlobal market of herbal drugs, Nutraceuticals ~$60 billion with 6% annual growth rate. Major share of Chinese and Koreans. Indian share variously estimated at 0.35-3.0%. Chinese production increased 200% between 1995-1999.Local acceptance: Developed tUSA: 42% use CAM spending over 29 billion US$ and 629 million visits in 1998. UK: 28% use, spent 1.6 billion pounds and 127 million visits in 1998. Australia: 60% use, A$ 620 billion in 1999. Developing Malaysia: Per capita consumption of traditional drugs, more than double of modern pharmaceuticals. S.Korea: Per capita consumption of traditional drugs 36% more than modern drugs.African countries: 9 to 10 patients attending hospital OPD have first consulted a traditional healer.

اسلاید 8: HERBAL DRUGS : RESURGENCE, OPPORTUNITY AND COMPETITIONWORLD-WIDETHE USE OF PHYTOPHARMACEUTICALS IS INCREASING @ 15% AGAINST 3% FOR MODERN PHARMACEUTICALS.THE NUMBER OF PEOPLE USING HERBAL PRODUCTS ROSE BY 50% LAST YEAR.35% OF OUT PATIENTS AND 22% OF INPATIENTS USE T.C.M. 940 HERBAL DRUG MANUFACTURING UNITS. HERBAL DRUG PRODUCTION ~ 18 BILLION CHINESE YUAN (DOMESTIC MARKETS). SALE OF HERBAL MEDICINE HAS 33% OF THE TOTAL DRUG MARKET.U. S. A.CHINAHanda 2003

اسلاید 9: GERMANYDOES NOT DIFFERENTIATE BETWEEN PHARMACEUTICALS AND PHYTOPHARM -ACEUTICALS.ANNUAL EXPENDITURE ON ALTERNATE MEDICINES AU $ 621 MILLION.HERBAL MEDICINE OUTPUT OVER US $ 500 MILLION WHICH ACCOUNT FOR 12% OF THE TOTAL DRUG OUTPUT.INDIA60-70% POPULATION USE DRUGS OF INDIAN SYSTEM OF MEDICINES.JAPAN147 HERBAL MEDICINES ARE ELIGIBLE BY NATIONAL HEALTH INSURANCE SCHEMEAUSTRALIA12% OF THE DAILY OUTPATIENTS VISIT T.M. PRACTITIONERS.R.P.D. KOREASINGAPOREHanda 2003

اسلاید 10: GLOBAL MEDICINAL PLANTS PRODUCT MARKETNUTRACEUTICALSttt HERBAL DRUGS US $ 250 BILLIONttt US $ 12.4 BILLION REGIONtt% MARKET SHAREECMtttt48REST OF EUROPEtt03JAPANtttt17REST OF ASIAttt20NORTH AMERICAtt12CHINESE HERBSttt18.7%HERBAL TEAttt14.5%OTHER ASIAN PLANTStt6.0%LOCAL AND OTHER IMPORTSt60.8%REF P. Brevoort, 1997% SHARES IN US HERBAL PRODUCT MARKET

اسلاید 11: GLOBAL SALE OF HERBAL DRUGS (BILLION US $; RETAIL)EUROPEttt7.0t8.9t1.9t27ASIAtttt5.1t6.0t0.9t17tN.AMERICAtt3.8t4.5t0.7t18tAUSTRALASIAtt0.12t0.14t0.02t17AFRICA +ttMIDDLE EASTtt0.19t0.21t0.02t24tS. AMERICAtt0.6t0.83t0.23t38E. EUROPEttt0.37t0.40t0.03t 8REST OF WORLDtt0.2t0.3t0.1t30

اسلاید 12: WORLD PHYTOPHARMACEUTICAL MARKETSOURCE : BUSINESS COMMUNICATION COMPANY INC.

اسلاید 13: SALE OF HERBAL MEDICINES IN DIFFERENT REGIONS OF THE WORLD* EstimatesttSource : IMS 1994; Gruenwald, 1997; Gruenwald, 2000

اسلاید 14: MOST FREQUENTLY PRESCRIBED MONO-HERBAL PREPARATIONS IN GERMANY

اسلاید 15: DEMAND FOR AYURVEDIC AND UNANI MEDICINES FROM TOP 11 COUNTRIESSOURCE: tPHARMABIZ 2001

اسلاید 16: Advantages of herbal drugsModern drugs can produce serious side effects Latrogenic diseases fourth leading cause of death in USA and other developed nations (JAMA, April 1998). Side effects of drugs kill more Americans annually than the world war II and Vietnam war combined (M. Rath N. Y. Times 28.2.2003). Around 2600 persons died in the Twin Tower tragedy on 11th September 2001 causing global repercussions. It is, however, not recognized that about the same number die in USA from side effects of prescription drugs every 10 days (JAMA, April 1998).

اسلاید 17: Herbal drugs are best suited for:PRIMARY HEALTH CAREINFECTIOUS DISEASES AIDS and other viral infections Opportunistic infections MDR infections (e.g. T.B., Malaria) DEGENERATIVE & GERONTOLOGICAL CONDITIONS Osteoporosis Chronic arthritis like osteoarthritis and rheumatoid arthritisNeurological like Alzheimer, Parkinsonism Anti-aging Metabolic disordersDiabetesDyslipidemiasOther conditionsMicrocirculatory disordersLiver diseasesImmunostimulantsAnti-cancerDrugs affecting male libido

اسلاید 18: Challenges aheadThe major challenge is quality control and standardizationScientific validation of the therapeutic claimsSafetyCustomer satisfaction and confidence

اسلاید 19: Three pillars of ideal herbal drug and their rational useQUALITYEFFICACYSAFETYGUIDELINES – RATIONAL USEAVAILABILITYACCESSABILITYQUALITYSAFETY EFFICACYAPPROPRIATE USE OF Herbal Drug

اسلاید 20: Standardization of Herbal drugs Raw DrugsPassport data of Raw Plant Drugs (Crude drugs)Correct taxonomic identification & authenticationStudy on the medicinal part: root, stem, bark, leaves, flowers, fruits,nuts, gum, resins etc.Collection details: Location, stage & development/ growth of the plants, time, pre-processing storage etc.Organoleptic examination of raw drug:Evaluation by means of sensory organs: touch, odour tasteMicroscopic & molecular examinationChemical composition (TLC, GLC, HPLC, DNA fingerprinting)Biological activity of the whole plantShelf life of raw drugs

اسلاید 21: Standardization of Herbal drugs- Herbal FormulationFollow defined Good Manufacturing Practices (GMP)Scientific VerificationToxicity evaluationChemical profilingPharmacodynamics – effect of drug in the bodyPharmacokinetics – absorption, distribution, metabolism, mechanism of action and executionDosageStability and shelf lifePresentation and PackingTherapeutic merits – Compared with other drugs

اسلاید 22: Good Survey of literature (Ancient & Modern)Develop and Observe Norms of:Good Agricultural Practices (GAP)Good Collection/Harvesting and Post Harvest Handling Practices (GCP/ GHP & GPHP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Good Manufacturing Practices (GMP) Good Marketing Techniques (GMT)Good Practices/Techniques in Herbal Products

اسلاید 23: Physico-chemical valueParameters required for quality evaluation of herbal drugs

اسلاید 24: QUALITY EVALUATION OF HERBAL DRUGSCHEMICALBIOLOGICALORGANOLEPTICBOTANICALPHYSICAL Moist. Cont. Extrac. Values Ash Values Fluores. Analy.MacroscopicMicroscopic Qualitative Quantitative SEM Studies Powder StudiesShapeExternalMarking Colour Odour Taste Texture FractureAntagonisticMicrobial ContaminationToxicologicalPharmacological Other specific activities Bacterial Fungal Qualitative Quantitative Chromatography Heavy metal Pesticide residue MycotoxinHPTLC GLC HPLCHPTLC Finger printing Sec. Metabolites DNA Finger printing Standardization & Quality Evaluation of Herbal drugs

اسلاید 25: Vision of Herbal Drug Industry“To provide intellectual capital to make available safe, cost effective, affordable therapeutics to the people of Indo-Pacific region – to help to reduce the percentage of mortality, morbidity and to emerge as significant players in the global market place.”

اسلاید 26: Problems faced by Indian Traditional MedicineReluctance to accept adopt and assimilate modern scientific methods and tools,Lack of consistency in quality in batch to batch productsAbsence of standardizationLack of systematic scientific documentation of the herbal drugsRare and endangered position of many important medicinal plants

اسلاید 27: CSIR initiatives in Traditional Medicine20 laboratory networked programme on discovery of bioactive molecules mainly based on the clues from traditional medicine. New Millennium India Technology Leadership Initiative (NMITLI) Programme. In this a number of non CSIR laboratories and pharmaceutical industries are also joining hands. It is intended to establish pharmacoepidemeological evidence base to Ayurvedic medicines, practice and development of standardized herbal formulations.t

اسلاید 28: Thank you

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