Herbal technology – challenges and opportunities for India – CSIR experience

1. Herbal technology – challenges and opportunities for India – CSIR experience P. Pushpangadan National Botanical Research Institute Rana Pratap Marg, Lucknow-226001

2. 21st Century 21st century is the century of Biology powered and propelled by scientific knowledge and technological expertise • Three 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.

3. Herbal technology All technologies for the manufacture of value added plant products can be called as herbal technology • Herbal drugs and pharmaceuticals, • Nutraceuticals, • Functional foods, designer foods or health foods and health drinks • Cosmaceuticals • Biocontrol agents • Biopesticides

4. WORLD TRADE AND ECONOMIES: THE PARADIGM SHIFT • “Resource – based economies’ to ‘Knowledge –based economies’ • 21 st Century will be the Century of Knowledge”…… “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)

5. Some features of international health care • Health care policies largely market driven by the pharmaceutical industry diverting attention from health preservation to illness cure • Prevention and eradication of diseases undermines the economic basis of this industry • No satisfactory drugs available for most of the degenerative disorders characteristic of graying population and for re-emerging resistant infections • Many 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)

6. Herbal drugs in international health care • Economic aspects: Global market of herbal drugs, Nutraceuticals ~$60 billion with 6% annual growth rate. Major share of Chinese and Koreans. Indian share variously estimated at 0.35-3.0%. Chinese production increased 200% between 1995-1999. • Local acceptance: • Developed • USA: 42% use CAM spending over 29 billion US$ 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.

7. HERBAL DRUGS : RESURGENCE, OPPORTUNITY AND COMPETITION THE USE OF PHYTOPHARMACEUTICALS IS INCREASING @ 15% AGAINST 3% FOR MODERN PHARMACEUTICALS. WORLD-WIDE THE NUMBER OF PEOPLE USING HERBAL PRODUCTS ROSE BY 50% LAST YEAR. U. S. A. 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. CHINA Handa 2003

8. 60-70% POPULATION USE DRUGS OF INDIAN SYSTEM OF MEDICINES. INDIA 147 HERBAL MEDICINES ARE ELIGIBLE BY NATIONAL HEALTH INSURANCE SCHEME JAPAN DOES NOT DIFFERENTIATE BETWEEN PHARMACEUTICALS AND PHYTOPHARM -ACEUTICALS. GERMANY ANNUAL EXPENDITURE ON ALTERNATE MEDICINES AU $ 621 MILLION. AUSTRALIA HERBAL MEDICINE OUTPUT OVER US $ 500 MILLION WHICH ACCOUNT FOR 12% OF THE TOTAL DRUG OUTPUT. R.P.D. KOREA 12% OF THE DAILY OUTPATIENTS VISIT T.M. PRACTITIONERS. SINGAPORE Handa 2003

9. GLOBAL MEDICINAL PLANTS PRODUCT MARKET NUTRACEUTICALS HERBAL DRUGS US $ 250 BILLION US $ 12.4 BILLION REGION% MARKET SHARE ECM 48 REST OF EUROPE 03 JAPAN 17 REST OF ASIA 20 NORTH AMERICA 12 CHINESE HERBS 18.7% HERBAL TEA 14.5% OTHER ASIAN PLANTS 6.0% LOCAL AND OTHER IMPORTS 60.8% % SHARES IN US HERBAL PRODUCT MARKET REF P. Brevoort, 1997

10. GLOBAL SALE OF HERBAL DRUGS (BILLION US $; RETAIL) EUROPE 7.0 8.9 1.9 27 ASIA 5.1 6.0 0.9 17 N.AMERICA 3.8 4.5 0.7 18 AUSTRALASIA 0.12 0.14 0.02 17 AFRICA + MIDDLE EAST 0.19 0.21 0.02 24 S. AMERICA 0.6 0.83 0.23 38 E. EUROPE 0.37 0.40 0.03 8 REST OF WORLD 0.2 0.3 0.1 30

11. WORLD PHYTOPHARMACEUTICAL MARKET SOURCE : BUSINESS COMMUNICATION COMPANY INC.

12. SALE OF HERBAL MEDICINES IN DIFFERENT REGIONS OF THE WORLD * Estimates Source : IMS 1994; Gruenwald, 1997; Gruenwald, 2000

13. MOST FREQUENTLY PRESCRIBED MONO-HERBAL PREPARATIONS IN GERMANY

14. DEMAND FOR AYURVEDIC AND UNANI MEDICINES FROM TOP 11 COUNTRIES SOURCE: PHARMABIZ 2001

15. Advantages of herbal drugs • Modern 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).

16. Herbal drugs are best suited for: • PRIMARY HEALTH CARE • INFECTIOUS 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 arthritis • Neurological like Alzheimer, Parkinsonism • Anti-aging • Metabolic disorders • Diabetes • Dyslipidemias • Other conditions • Microcirculatory disorders • Liver diseases • Immunostimulants • Anti-cancer • Drugs affecting male libido

17. Challenges ahead • The major challenge is quality control and standardization • Scientific validation of the therapeutic claims • Safety • Customer satisfaction and confidence

18. Three pillars of ideal herbal drug and their rational use QUALITY APPROPRIATE USE OF Herbal Drug GUIDELINES – RATIONAL USE QUALITY SAFETY EFFICACY ACCESSABILITY AVAILABILITY SAFETY EFFICACY

19. Standardization of Herbal drugsRaw Drugs • Passport data of Raw Plant Drugs (Crude drugs) • Correct taxonomic identification & authentication • Study 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 taste • Microscopic & molecular examination • Chemical composition (TLC, GLC, HPLC, DNA fingerprinting) • Biological activity of the whole plant • Shelf life of raw drugs

20. Standardization of Herbal drugs-Herbal Formulation • Follow defined Good Manufacturing Practices (GMP) • Scientific Verification • Toxicity evaluation • Chemical profiling • Pharmacodynamics – effect of drug in the body • Pharmacokinetics – absorption, distribution, metabolism, mechanism of action and execution • Dosage • Stability and shelf life • Presentation and Packing • Therapeutic merits – Compared with other drugs

21. Good Practices/Techniques in Herbal Products • 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)

22. Physico-chemical value Parameters required for quality evaluation of herbal drugs

23. Standardization & Quality Evaluation of Herbal drugs • Shape • External • Marking • Qualitative • Quantitative • SEM Studies • Powder Studies • Colour • Odour • Taste • Texture • Fracture Macroscopic Microscopic BOTANICAL ORGANOLEPTIC • Moist. Cont. • Extrac. Values • Ash Values • Fluores. Analy. QUALITY EVALUATION OF HERBAL DRUGS PHYSICAL Microbial Contamination BIOLOGICAL CHEMICAL • Toxicological • Pharmacological • Other specific activities HPTLC Finger printing Sec. Metabolites DNA Finger printing • Qualitative • Quantitative • Chromatography • Heavy metal • Pesticide residue • Mycotoxin Antagonistic HPTLC GLC HPLC • Bacterial • Fungal

24. 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.”

25. Problems faced by Indian Traditional Medicine • Reluctance to accept adopt and assimilate modern scientific methods and tools, • Lack of consistency in quality in batch to batch products • Absence of standardization • Lack of systematic scientific documentation of the herbal drugs • Rare and endangered position of many important medicinal plants

26. CSIR initiatives in Traditional Medicine • 20 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.

27. Thank you