Development Of Traditional Drugs For Global Positioning With Major Emphasis On Efficacy And Safety

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Development Of Traditional Drugs For Global Positioning With Major Emphasis On Efficacy And Safety ۱۸۳۵۲۵۱۵۱۵8۵۵ ۷ ‏ليك‎ ‎Traditional Medicine, Delhi (16-17 November 2006) C K Katiyar Director - Herbal Drug Research Ranbaxy Research Laboratories Plot 20, Sector 18, Gurgaon, Haryana (INDIA) 

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FLOW OF PRESENTATION ~ Introduction » Why Global Strategy ~ Results of Global Survey of Regulatory Status ~ Global Vs Regional Strategy ~ Proposals 

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USE OF CAM IN THE UNITED KINGDOM ۵/0 ای ‎Use of any CAM in past 12 months 20‏ Of which: * 34 عمءتألعم اأوطرعط 21 تت یی ید Homeopathy ee Acupuncture / acupressure 14 Massage 6 Reflexology 6 Osteopathy 4 Chiropractic 3 Ra ee he aA ea ,100 16 فنا 304 64 ‎ea a oe eee‏ 3/00 برمق ع7 ‎ee Ree acne are‏ عن" يم ,علاطلا 6 .ع ومع ا ۱ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ 

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USE OF CAM IN THE USA CAM 1990 (%) | 1997 (%) Use of any CAM in past 12 months 33-1 42.1+ 0۲ ۷۳۶ Relaxation techniques i321 16.3 ‏عمءتلعم اأوطرعط‎ 25 12.1 Massage 69 121.1 Chiropractic pie 11.0 Spiritual healing 4.2 7.0 Homeopathy 2 3.4 Acupuncture ۳ 1.0 Percentages of the total sample population (1539 for the 1990 data, 2055 in 1997) + Table shows selected figures relating to the top five therapies based on the 1997 survey Eisenberg, D.M., Davis, R.B., Ettner, S.L. et al. 'Trends in Alternative Medicine Use in the United States, 1990-1997: Freee Nae eet es eg ee ae eee Cee ‏ا ا‎ 

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۴۸۵۲۱ ۲۳/۵۵ ۸۵۵ ~ Own Fundamental Principles ~ Own Unique Ingredients ~ Own Composition ~ Own Process of Manufacturing 

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GLOBAL SCENARIO 

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GLOBAL SCENARIO ری ی رن ی 1 1 ‏ل ل‎ 2 POR MMe Mae ‏ا‎ 2 2 2 a herbal drug market is estimated to be around $ 25 Billion. Worldwide phytopharmaceuticals market is growing @ 12%. HOR, MRD ORDE DORON (S ADPOHEG ) | ال 

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WHITHER GLOBAL STRATEGY? 

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INCREASING POPULARITY ۸۱0۵ 5 CRITICISM ARE WE PREPARED TO FACE IT @ 

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TRADITIONAL SYSTEMS OF MEDICINE REMEDY OR FALACY PANACEA OR POISON THE DEBATE STILL GOES ON.......... 

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2000 Obach RS. J Pharmacol Exp Ther. Jul;294(1):88-95 CONCLUSIONS: In vitro data indicate that St. John's Wort preparations contain constituents that can potently inhibit the activities of major human drug-metabolizing ی وت ‎Not Much‏ ارت را زد ‎Tinley tol Mole‏ ‎Lore ame Lo Don’t give credence to‏ researches conducted by Scientists who don’t know the subject 

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2 0 0 3 Taylor et al. JAMA. Dec 3;290(21):2824-30 CONCLUSIONS: Echinacea purpurea, as dosed in this study, was not effective in treating URI symptoms in patients 2 to 11 years old, and its use was associated with an increased risk of rash. 

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2 0 0 3 Szapary et al. JAMA. Aug 13;290(6):765-72 CONCLUSIONS: Guggulipid did not improve levels of serum cholesterol over the short term, and might in fact raise levels of LDL-C. اه اه‌نطنا) وطانلدوع۳ دتما ۲۳۵8 ع7عهاهز8 وا انیت وا وت زرا 

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2 0 0 4 Saper et al. JAMA. Dec 15;292(23):2868-73 CONCLUSIONS: 17 out of 70 Ayurvedic/Unani medicines contained heavy metals, therefore, not safe to be consumed. Does mere presence of a heavy metal in trace amounts in a plant source of soil/other origin make it toxic? 

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Saper et al. 2004. JAMA. Dec 15;292(23):2868-73 17 out of 70 Ayurvedic/Unani medicines contained heavy metals, therefore, not safe to be consumed. ST Nar ek) Health Canada & MHRA of UK bans Indian Ayurvedic drugs based on controversial JAMA report October 26,2005 Central Government of India makes heavy metal testing mandatory for Ayurvedic drugs to be exported effective Jan |, 2006 November 17,2005 MHRA of UK recovered further Chinese/Ayurvedic products containing heavy metals 

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WHO - GLOBAL SURVEY (141 countries) Traditional Medicine/Complementary and Alternative Medicine products are used under the categories which include ~ Prescription products ~ OTC products Self medication Dietary supplements Health foods ~ Functional foods & Oo) age) ۱ ۲ ۱ ۱ World Health Organization (2005), National Policy on Traditional Medicine and Regulation of Herbal Medicines. eee Rone eae Oe aT 

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WHO - GLOBAL SURVEY وا مات تا فا یت تال ایس کت ها تال تن تیا A.POLICIES Tia a Nagel y Present PS 000 45 (32%) 90 (64%) Der mC RCL rel 54 (38%) 84 (60%) ۱ ‏یت‎ ce ‏رت‎ 40 (28%) 93 (66%) ۱ ‏رت یت‎ 75 (53%) 61 (43%) ]3 ۰ ‏ممم وت‎ tc} ۵9 75 (51%) ‏نكمم‎ ‏که)[6۵ ۲۳۵۵00۱ (2790) 38 اعم وعوعء أهممغقلة‎ Te oe di 46 )3396( ‏كعماء العم اقطععط‎ 9 (6%) CAM 

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WHO - GLOBAL SURVEY وا مات تا فا یت تال ایس کت ها تال تن تیا B. LAWS & REGULATIONS Survey Attributes etd Eig ۱۱۹۳۰ ‏و‎ 92 )6590( 48 )3490( ۱ eae 41 0 ‎hor} 22‏ ل يا ل ا نا ‏47 تسه 35 53206 .ع ‎Registration system exists 85 )6190( 54 (38%)‏ .2 ‎Post Marketing Surveillance 59 (42%) Peary)‏ .3 ‎ ‎ ‎ ‎ ‎conducted ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ 

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WHO - GLOBAL SURVEY ine/Complementary & Alternative medicine ۱۵881 6۵1 c. STATUS OF PHARMACOPOEIA سا ال كذ 34 )2490( 58 (56%) 31 )30960( Survey Attributes 00 لومعم edamame nec ۱ 

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WHO - GLOBAL SURVEY وا مات تا فا یت تال ایس کت ها تال تن تیا D. LEGAL STATUS ۱۷۰ 75 دشیم توت ‎ence ner ny 29 (85%) 4 )1290(‏ 1۱1 ومتفماط National monograph on herbal 46 )3396( 90 )6396( ۶060166 ۵ Other monographs in use 34 (38%) )43%( 39 0کن ۱۵۵۵9۲۵۵۳5 ولا renee ae eer bait lat) 24 (52% of 46) 17 (37%) 

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WHO - GLOBAL SURVEY ات یا ات یوت ام 4 ق یت یت زا کات ها پیب ریت اک یره E. NATURE OF CLAIMS ALLOWED ‎Bo CL) ۱۱۰ 0۲ ۵۵‏ 90 كحطلقاء اقعألعالا 62 تب کنات ریا 49 ۱۱۳ ‎Ty 39‏ ی ری رای یت ‎Other claims 6‏ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ 

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So Much Diversity Justifies A REGIONAL STRATEGY ۳۵۲۳۵۲۳ ۰ GLOBALLY HARMONIZED STRATEGY 

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Guiding Factors for REGIONAL STRATEGY ~ History of Use of Traditional Medicines ~ Regulatory Requirements ~ Geographical Considerations ~ Socio-Economic Conditions ~ Level of commitment of respective Governments and their policies for Traditional Medicines ~ Prevalence of sound system of Traditional Medicines 

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Development of Traditional Medicines Zoopharmacognosy Tribal Practices Observation ‏عولع اللام ما‎ 53560 Philosophical | | ۱ Strong fundamental eX RU ‏این‎ Documentation ‏تکیت‎ ‎6 ‎Ethnobotanical Well developed ‏رابنیا‎ practices ۲6۲۵۵۱ 0۲۵066 55 ‏هن‎ ۲0۷ 6 ۷۵۵ ۱ QUALITY, SAFETY, EFFICACY, AFFORDABILITY 

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Classification of Geographical Regions basis Traditional Medicine usage A. Countries with no official recognition to Traditional medicines & no regulatory mechanism viz. Africa Focus on Authentication and adulteration B. Countries with strong traditional systems of ‏تفه رای متیر‎ Focus on Standardization C. Countries with no traditional systems but strong herbal practices viz. Europe & USA Focus on Efficacy evaluation 

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Safety Aspects of Traditional Medicine ‎Tully‏ لاه ةاباوعظ جره كعأغصيامء 130 مذ بإعيمنب5 ولإلالا ‏ات يك را امع تمع لا توق تال ترا 82 عمعمعمأنوعء اواععم5 ‎Traditional use without harmful effects 6‏ - 53 ال ل اه ‏کاءنا۵ه۵۲ ۵۲ا اک مه ‎0 tse eT ete Ce) 21 5۵06 ‏اف تاباع> ۴۳۵۲0۵ که‎ 57 ۱ 28 ‎liad‏ ل ا ل ل ينانا ‎World Health Organization (2005), National Policy on Traditional Medicine and Regulation of Herbal Medicines. eee Rone eae Oe aT 

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Indian Council of Medical Research guidelines for safety on products of Indian System of Medicine “Since the substance to be tested is already in use in Indian Systems of Medicine or has been described in their texts, the need for testing its toxicity in animals has been considerably reduced. If there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months it would be necessary to undertake 4-6 weeks toxicity study in 2 species of animals”. Indian Council of Medical Research (2000). Ethical Guidelines for Biomedical Research on 0 

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DRAFT Indian guidelines of Safety on Non-Ayurvedic Herbal Medicines ‎ry prc)‏ تفا ‎Cren ackaens‏ 01 ا ‎1 Those not containing poisonous plants ‎۳۹7 17 eit ‎۹7 Pen aca ens ‎0۹۹ Processed or unprocessed _ parts A Jel ia Tae Le ۱86۲۵۱ substances and/or products ‎ ‎ ‎Govt. of india, Circular No. 4-5/93 (1993). Issued by Drugs Controller India, Directorate of Health Services, Pear uray a ec ‏أااع0‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ 

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DRAFT Indian guidelines of Safety on Non-Ayurvedic Herbal Medicines fe tty Sub | Formulation | Toxicity requirements ‏یی ای‎ ‏ا م اععدا‎ ‏ا‎ 7 0 Sn Renn ress ‏ا‎ ‏م‎ 0 0 00 5 0 2 0 Kanes ‏ا‎ 7 0 0 5 ‏اقعأومامء “امع اانع | عع ارقم ما‎ مممقاع‎ ‏"ل" عانالعداء5 مغ ومأل,مععق‎ Govt. of india, Circular No. 4-5/93 (1993). Issued by Drugs Controller India, Directorate of Health Services, Pe me aay ea er 

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Efficacy Aspects of Traditional Medicine WHO recommends the following: A. Evaluate traditional medicine in its own theoretical framework B. Evaluate traditional medicine in the theoretical framework of conventional medicine C. Compare the efficacy of traditional medicine with conventional medicine D. Compare the efficacy of traditional medicine within the system of traditional medicine World Health Organization (2000). Annexure IV. General guidelines for methodologies on research Pree teatro enemy 

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WHO-Levels of evidence for Efficacy studies eT LoL) CMe eae a a Mee et Reece ‏ادن‎ Oe ‏ا ل‎ ‏ی‎ en con nan ‏ی ییا وا‎ ‎ea‏ ل ا لان هزات ۲۵۵۵۴/2۵۵ ده ‎Tee om‏ ۱ ‎St ee cet‏ یت ی ترا ی رت ‎ee tact eno ecco ott‏ ‎eek tom‏ عاطقعناممة /زلغعع 17ل 0 ‎ ‎ ‏ا اعا/ء6:20 ‎7 ‏ل 000 انق لع امهم ۲۵۵۵0۴۵26۵ ‎۱۱ ‏ل ا‎ randomized controlled trial ‎8 ‏ل اي ا ‎Tee‏ ‎TS‏ لل ‎Pee‏ ‏یت رم ‎lib. Evidence obtained from at least one to] ‏ل‎ ‎eae ‎lll. Evidence obtained from well-designed eae nes een sae oe a Execute ‏اي‎ ocd 200 ‏کهآهبناه اهتاوی مکی‎ ‎5 ‎Vue MC ‏ل‎ ‏ل‎ Ce ‏ال‎ ig fine setae Remo aoe Mg ey ‎ ‎ ‎ ‎ ‎ ‎ 

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European Union Aspect Ce eee le elma (era Simplified | Bibliographic | Full Clinical (۵0 (0 ‏دنا‎ ear) ۹ Cates ۹ Estima 1 cc) ۷ ۱ 0 Yes 0 Finland 0 ca 0 France ۷6 5) ۹ eared ۷5 7 21 91 0 3 ۷ een) 10 Cc) 2 ۳17 01 Yes ۹ ]1۳ 0 ‏)و06‎ cs) Netherland 0 Cc) 2۹ Bored 01 ۲22 Yes Ga ۹ 7 Yes 5 0 Yes ۷ Ue ‏كوم‎ 0 a 3 یر ۱۳ ۱ 

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Proposals for Regional Positioning of Traditional Medicines - SAFETY عه ‎ee (al MoMA eee‏ صاهاصی ۵۷ كعماء العم اقمماء ألم عط عععزو 1 Met eum MMC acme motes] تخل ‎food‏ Brees eae RMR steak Rae ad 1 Tox 28 day 3 دنتسا دنه ونمك كه دوداء (۳۰۱ eee Mee euR ates ea ‏ی‎ ate merece creme ‏يع مواق انامممه؟ ,دماغ یر‎ use) عمءأمعم امععم ام ۳۱۳۹۳۰۱۱ 3. Herbo metallic medicine 4. Herbal Medicine containing known ۱۵6 6۲۵5 اه ۳/۳ 

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Proposals for Regional Positioning of Traditional Medicines - EFFICACY Adopt a flexible approach to review the data with respect to efficacy. Randomized double blind placebo controlled studies may not be always suitable to evaluate the efficacy of Traditional Medicine products. 

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Proposed Parameters for assessing Efficacy of Traditional Medicine Sect rele neers Patience eeu eke ao) 3. |Uses mentioned in Pharmacopoeia & Monographs e.g. Ayurvedic ‏ممأددتممممم مقصمء6 ,كطمقعوممها/! 0لنللا ,دتما كه وأعوممءقممهمم‎ 8 اتید هراتس۱ PM nrc e au ence curiae uc e) سلطا تس 00 stucco anrl «واعهه ععی عاوما5 ,(2 ۱ ei omar ard ۱3 ‏ری‎ mars ۱ ۱ 0 ee Kee تفت ی ۱ 

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ار 00 000 ‏ا ل‎ Trial 5 NA errant) 1 ۳ ۳ »6 6غ 0368 الت age 0 eo) products لاقم not mentioned in traditional ETc pac) Cran) Cre eee (۰ ری لس ۱ ۳7 ۳ ۳7 ۱ ‏ور‎ od As per text ها عم عم »ده )عم كم يه )عم كم كمع و رت ۱5۳۰۳ Nees ma a) A. With ingredients mentioned in the ASU Peete cece eee era ECE NAMM ieee Rat) ۵ ۱3 ‏ناكم عط مأ لعممءمعم كمع امعءوما‎ books & products for same indication in ‏را سای‎ En eed urn kk) ‏الاعم 6ن؟ معدن عط 6غ عباط كاده‎ ee ares ce ee nee ‏عامط ینز سا‎ enue arcs ‏تفای یزیر‎ عه؟ غم رقم ی ۱ كقعا 5 مقط دعا Cerrone acura ued) 

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Efficacy ‏تلف اسر‎ 5 2 Eile اهتمع ص امع ميرع 2200 رن ‎Efficacy‏ ‎etnies‏ ‏اهتمع ص تمع ميرع ‎Beret‏ ‏۵۵0 ‏رت ‎eres‏ This may be modified for assessing the Efficacy of Traditional Medicines to evolve a Regional Strategy تیاه Traditional Traditional ۳17 ۸ ۱۱۲9 0۳06655 Bc eeu Modified oy eens تاره ‎Traditional‏ Traditional یت یرای ۱۴ 53 5 ™ Product تاره ‎Traditional‏ لاعلا 

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SUMMARY » The popularity of Traditional Medicines is on a Northward movement > Due to non-uniformity in their status in various countries, Regional harmonization strategies are more appropriate than developing Global strategies » Stepwise flexible approach should be adopted for considering quality, regulatory, safety and efficacy requirements considering multiple factors » Traditional/Historical use and Bibliographical referencing should be given due importance but should not be allowed to be used as a shield 

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ACKNOWLEDGEMENT Dr Navin Sharma Sr Res Scientist Herbal Drug Research Ranbaxy Research Labs ۱ 7 

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THANKS