future of herbal industry

8/12/2019 Future of Herbal Industry

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Future of Indian Herbal Industry – Trade-ition Or Trend-ition?

Dr Arun Bhatt MD (Med) FIC (Ind) MFM (!")residentClinIn#ent $esear%h #t &tdMu'baiarunbhatt%linin#ent%o'

“If you want to know your past, look into your present conditions.If you want to know your future, look into your present actions.”

- A Chinese Proverb

“ Nobody can really guarantee the future. he best we can do is si!e up the chances, calculatethe risks, esti"ate our ability to deal with the" and the" "ake our plans with confidence. “

#enry $ord II

Introdu%tion

%lobally, herbal "edicine has beco"e an increasingly co""on for" of alternative therapy. A&''( survey esti"ated that &).& percent of adults in the *nited +tates had used an herbal"edicine in the previous &) "onths as co"pared with ).- percent in &''/. & Annual sales ofherbal drugs are appro0i"ately 12 billion in %er"any and 1&.- billion in the *+. %reateracceptance of herbal "edicine "ay be attributed to increased appreciation of products ter"ed3organic3 and 3all natural34 disenchant"ent with traditional "edicine because of its inability tocure everything4 fewer side effects perceived or observed with "any gentle herbal re"edies4 andthe relatively low cost of herbal products.5&6 In the *+, phar"aceutical co"panies are generally not interested in funding clinical trials.#owever, in %er"any, where herbal products are widely used, the %er"an $ederal #ealth

Agency for"ed Co""ission 7, a group of reputable scientists and practitioners with a "ission tocollect data on the safety and efficacy of co""only prescribed herbs. 8ore than 2 "onographshave been co"pleted to date, and 7nglish translations are e0pected to be "ade available in &''9

by the A"erican :otanical Council in Austin, e0as.In the *+, the ;ietary +upple"ent #ealth and 7ducation Act of &''< established a federalfra"ework for the regulation of product labeling and infor"ation about dietary supple"ents.;ietary supple"ents are, for the first ti"e, specifically defined to include vita"ins, "inerals, herbsand other botanicals, a"ino acids, and other dietary substances used to supple"ent the diet.5)6 he act also allows product labeling to contain a state"ent describing how the product=sconsu"ption effects 3structure or function3 or general well>being in hu"ans. #owever, it does notper"it a "anufacturer to "ake a specific health clai" for a product. he product label "ust carrythe disclai"er? 3his state"ent has not been evaluated by the $ood and ;rug Ad"inistration.his product is not intended to diagnose, treat, cure, or prevent any disease.3526 he total @uantityof all ingredients and the phrase 3dietary supple"ent3 "ust also be included on all labels.Clinical trials that have been designed to test currently used herbal preparations are laborious,ti"e>consu"ing, and costly, and it is understandable why "any herbal preparations on the

"arket do not go through rigorous testing procedures.Nonetheless, "any consu"ers have turned away fro" conventional "edicines, believing that3natural3though untestedsubstances such as herbs are safer than synthetic substances.:atch>to>batch variability, however, is a significant proble" with herbal preparations. Co"paniesthat produce these preparations generally do not e"ploy rigid @uality controls, do not haveade@uate personnel or standards, and do not evaluate their products for purity and reliability.Contradictory phar"acologic effects have also been reported as a result of herbal preparationscontaining different subspecies of plants or having alterations in the che"ical co"position ofactive ingredients. :ecause herbal preparations are usually not evaluated for purity andconsistency of active co"pounds, they often contain accidental conta"inants, such as allergens,

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pollen, "old, and "old spores. 5<6 In addition, so"e herbs are edible when i""ature butpoisonous at "aturity.In general, side effects fro" herbal products are "ini"al. 8any consu"ers are entranced by thedesignation 3all natural3 and thus tend to believe that all herbal products are safe. hey do notthink of herbs as drugs. he consu"er should be advised by providers of "edicinal herbs toobserve the proper dosage reco""endations and stop taking the herbal product if any adverseeffects occur. Bther concerns regarding herbals involve their use by pregnant or nursing "othersand by young children and infants. here is not "uch infor"ation on drug herb/>druginteractions, so people taking prescription "edications should be cautious. he :otanical +afety#andbook published by the A"erican #erbal Products Association contains labelingreco""endations for ( herbs co""only used in the *+.

A provider of herbal "edicines should ask a consu"er the following @uestions?#ave you used this product before

Are you allergic to any plant productsIs this product for personal use or for so"eone else, such as a child or elderly patient

Are you pregnant or breast>feeding Are you aware of the i"portance of closely following label instructions for dosages and durationof use

Are you taking prescription or nonprescription "edications intended for the sa"e purpose as thisherb

Alternative "edicine is hitting the *+ like a stor". +ales of herbal "edications now e0ceed 1&.-billion a year and are increasing annually by about )-D. Ehile herbal products have been used inother countries for "any years, their popularity in the *+ has grown dra"atically within the last Fyears. Consu"ers here are seeking alternative therapies to supple"ent "odern conventional"edicine. here are appro0i"ately )-, plant species in the world4 of these, nearly &9 areavailable for use in the *+. his article reviews indications, dosing, side effects, and druginteractions of < of the big sellers7chinacea, garlic, %inkgo biloba, and ginseng. #erbal"edicine is big business. Gong popular in "any parts of the world, its use has increaseddra"atically in the *+ in recent years. Product sales now nu"ber in the billions of dollars and areincreasing by about )-D annually. #eightened interest in herbal re"edies has also spurredcontrolled scientific research into their efficacy and safety. In Part ) of their article, theinvestigators review the indications, dosing, side effects, and possible drug interactions of ) of thetop sellers+t. Hohn=s wort and saw pal"etto.

8uller HG, Clauson A op #erbal Products 7ncountered in ;rug Infor"ation Je@uests Part &/;rug :enefit rends &''9 &?<2>-/

A"ong the first drugs for treat"ent of high blood pressure was reserpine fro" the herb Rauwolfiaserpentina, described "any centuries ago in Indian Ayruvedic "onographs. Indeed, so"e of our"ost i"portant drugs, while not originating as CA8 therapies, are derivatives of the activeingredients identified in herbal re"edies. +uch drugs of botanical origin include digitalis for thetreat"ent of congestive heart failure and vincristine, and "ore recently, ta0ol, for treat"ent ofcancers. here are indications that other herbal re"edies and CA8 practices "ay prove effectivein preventing and treating chronic diseases, possibly reducing the costs of healthcare, as well asadvancing our understanding of how healing works. At present, however, few of these practiceshave been tested for safety and effectiveness. +till others await discovery and validation of theirworth.

The ast * Tradition to Trade-ition$or e0a"ple, after visiting the Central Institute of Jesearch in Indigenous +yste"s of 8edicine atHa"nagar on )nd Nove"ber &'--, Pandit Hawaharlal Nehru had observed K Lafascinating in@uiry is going on in this research institute and it "ay welllead to very fruitful results. he only right approach has to be one of +cience, that is, of e0peri"ent, trial and error. In whatever type of "edicine we "ay deal with, we cannot profit by its study unless weapply the "ethod of science. Nothing should be taken for granted.7verything should be tested and proved and then it beco"es a part of scientific "edicine K old and new.M *nfortunately this "essage, which



was given al"ost - years ago, has been lost so"ewhere.

Mar+ethe total 7uropean over the counter "arket for ho"oeopathy was -'" in &''&, co"pared with&.<-bn for herbal "edicines

,ie . /ro0th of Mar+et for I,M

Mar+et ,ie In Million

Ayurvedic "edicines Js. 2-, *+1 9)<#o"eopathic "edicines Js. F, *+1 &<&+iddha "edicines Js. - *+1 &.&(*nani "edicines Js. &, *+1 )2.-

Previous 2 year CA%J &)>&-D7sti"ated "arket growth &->)D

According to the Eorld #ealth Brganisation esti"ates, the present de"and for "edicinal plants isabout *+ 1&< billion a year and proOected de"and by the year )- is *+1- trillion. 8edicinal

plant related trade in India is esti"ated to be around Js.-- crores per year. Ehile the value ofglobal trade in "edicinal plants has been put at over 1F billion per year, Indians total turnover ofJs. )2 crores of Ayurvedic and herbal products, "aOor over>the>counter BC/ productscontribute around Js.&) crores.

Bther for"ulations fetch around Js.F- crores. And classical Ayurvedic for"ulations contributethe re"aining Js. <- crores. Eith world de"and growing at &D annually, the e0port "arket for"edicinal plants appears to be growing faster than the Indian do"estic "arket.

he Js <, crore Js < billion/ Indian herbal drug "arket, which is split between ethical >> thatis, drugs that re@uire a doctor=s prescription >> and over the counter drugs, is growing by over &-per cent a year against the co"pounded annual growth rate of around 9>' per cent reported bythe Js ), crore Js ) billion/ allopathic drugs "arket.

%lobally, the herbal "edicine "arket is valued at around 1F billion, half of it in 7urope alone.+"all beer when co"pared with the 1< billion allopathic drugs "arket.

8ost observers say that Indian co"panies will first launch ethical herbal drugs in India, and willlater develop new drugs, focus on e0ports and try to con@uer the world >> a prescription followedby their allopathic counterparts in India.

$e1ulatory Trends

7C directive F-F- on proprietary "edicinal products has considerably

constrained productlicences for herbal "edicines.)9 Concern at the possible carcinogenic effects of pyroli!idinealkaloids, which occur in a nu"ber of "edicinal herbs, "ost i"portantly co"frey +y"phytu"officinale/, has recently pro"pted both the %er"an and :ritish govern"ents to restrict theavailability of these herbs. he case of co"frey highlights a regulatory proble">>the plant isco""on in "any 7uropean countries and is so"eti"es taken as a tea or vegetable? should ittherefore be viewed as a food or as a "edicine his proble" re"ains unresolved4 the 7uropeanCourt of Hustice has had to adOudicate on whether vita"ins and herbal "edicines are foods or"edicines cases ))(9) and 2F'99/.

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Medi%al #ie0s

+urveys of doctors= attitudes to co"ple"entary "edicine show that, overall, physicians believe itis "oderately effective, but low response rates "ake so"e studies unreliable. Although hospitaldoctors and older general practitioners tend to be "ore sceptical than younger doctors and"edical students, "ost respondents believe that so"e of the "ore established for"s are ofbenefit and should be available on the N#+. Qounger doctors and "edical students are "orelikely to perceive their knowledge of co"ple"entary "edicine as inade@uate and to want "oretuition in the subOect.Rualitative research shows that "any doctors want to be supportive of patients= choices andwould welco"e further infor"ation, although they generally regard co"ple"entary therapies asscientifically unproved. ;octors= concerns about such therapies include whether they are used asan adOunct or an alternative to conventional care, how effective conventional treat"ents are in thegiven condition, and the possibility of adverse effects.Soll"an C, Tickers A . A:C of co"ple"entary "edicine Co"ple"entary "edicine and the

doctor :8H &'''42&'?&--9>&-F&/

:AC%JB*N;? Co"ple"entary or alternative/ "edicine has beco"e a prevalent pheno"enonin "ost industriali!ed countries. At present the evidence fro" rando"i!ed controlled trials

investigating its effectiveness is frag"entary and therefore inconclusive. B:H7CIT7? o assesswhether physicians perceive co"ple"entary "edicine as useful andor effective. 87#B;? Aliterature search was perfor"ed to retrieve all relevant articles. welve surveys addressing this@uestion were found and analy!ed by evaluating perceived usefulness andor effectiveness.J7+*G+? he results show a re"arkable variability between surveys. Bn average physiciansperceive co"ple"entary "edicine as "oderately effective>>the rating was <F U> &9 on a scale of to & points. Qoung physicians see" to Oudge co"ple"entary "edicine "ore opti"isticallythan their "ore seasoned colleagues. here is no trend to suggest that co"ple"entary "edicineis increasingly perceived as useful andor effective. he data do not answer the @uestion whetherphysicians view co"ple"entary "edicine as a nonspecific powerful placebo or as specificallyeffective. CBNCG*+IBN? Co"ple"entary "edicine "ay be useful4 however, the notion urgentlyneeds to be tested in rando"i!ed controlled trials.7rnst 7, Jesch G, Ehite AJ. Co"ple"entary"edicine. Ehat physicians think of it? a "eta>analysis. Arch Intern 8ed &''- &--?)<->9/

Percentage of public reporting use of co"ple"entary "edicine>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Any for" of 8anipulation Phytotherapy co"ple"entary including osteopathy or Country "edicine Acupuncture #o"oeopathy and chiropractic/ herbalis">>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>:elgiu" 2& &' -F &' 2&;en"ark )2.) &) )9 )2 N;

$rance <' )& 2) ( &)%er"any <F N; N; N; N;Netherlands ) &F 2& N; N;+weden )- &) &- <9 N;*nited ingdo" )F &F &F 2F )<*nited +tates 2< 2 2 2 '>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> N; V data not available.



$isher P, Eard A 8edicine in 7urope? Co"ple"entary "edicine in 7urope :8H &''<42'?&(>&&& ' Huly/

2ualityJesults A total of &< )D/ of ( #8Ps '-D confidence interval, &&D>2&D/ contained heavy"etals? lead n V &24 "edian concentration, < Wgg4 range, ->2( /, "ercury n V F4 "edianconcentration, ) ))- Wgg4 range, )9>&< /, andor arsenic n V F4 "edian concentration, <2Wgg4 range, 2(>9&2/. If taken as reco""ended by the "anufacturers, each of these &< could

result in heavy "etal intakes above published regulatory standards.

Conclusions Bne of - Ayurvedic #8Ps produced in +outh Asia and available in :oston +outh Asian grocery stores contains potentially har"ful levels of lead, "ercury, andor arsenic. *sers of Ayurvedic "edicine "ay be at risk for heavy "etal to0icity, and testing of Ayurvedic #8Ps forto0ic heavy "etals should be "andatory.

+aper J:, ales +N, Pa@uin H, :urns 8H, 7isenberg ;8, ;avis J:, Phillips J+ #eavy 8etalContent of Ayurvedic #erbal 8edicine Products JAMA. )<4)')?)9F9>)9(2/.

he growing popularity of traditional Indian re"edies necessitates a critical evaluation of risksassociated with their use. his syste"atic review ai"s at su""arising all available data relatingto the heavy "etal content in such re"edies. Co"puterised literature searches were carried out

to identify all articles with original data on this subOect. $ifteen case reports and si0 case serieswere found. heir collective results suggest that heavy "etals, particularly lead, have been aregular constituent of traditional Indian re"edies. his has repeatedly caused serious har" topatients taking such re"edies. he incidence of heavy "etal conta"ination is not known, but onestudy shows that F<D of sa"ples collected in India contained significant a"ounts of lead F<D"ercury, <&D arsenic and 'D cad"iu"/. hese findings should alert us to the possibility ofheavy "etal content in traditional Indian re"edies and "otivate us to consider "eans ofprotecting consu"ers fro" such risks.

7rnst 7. #eavy "etals in traditional Indian re"edies 7ur H Clin Phar"acol )) -(?9'&>F/

It is only fair to e"phasi!e that the heavy "etal content of traditional re"edies is not solely aproble" of traditional Chinese re"edies. Indian traditional "edicines)' and re"edies fro" the

8iddle 7ast2)

and +outh A"erica22

have also been i"plicated. It is therefore i"portant thatregulatory "easures ai"ed at "ini"i!ing the risks associated with such traditional treat"ents arenot e0clusively targeted at C8s. 7rnst 7, ho"pson Coon H #eavy "etals in traditionalChinese "edicines? A syste"atic review Clin Phar" herap )& (/

Clini%al !se A Cautionary ale XPlacebo &.2

I"ipra"ine &).

+t. Hohn=s Eart &2.<$igure ) indicates the pro"ise of +t. Hohn=s wort as an antidepressant in a study showing that itco"pares favorably with a standard anti>depressant, i"ipra"ine, and that both are significantlybetter than placebo '/ X

X#owever, $igure 2 indicates that if +t. Hohn=s wort is taken by subOects who are also takingindinavir, an #IT protease inhibitor, levels of indinavir in the blood are reduced below the levelre@uired to block #IT "ultiplication. J7+7AJC#The Clinical Imperative. he e0tensive use of untested CA8 practices by the public dictates thatNCCA8 "ake clinical research &-/ its highest priority and the centerpiece of its researchportfolio. In this regard, the Center=s approach differs significantly fro" that of the other NI#Institutes and Centers where the e"phasis is on the discovery of new knowledge through basicresearch. In contrast CA8 consu"ers and healthcare practitioners want to know now whetheravailable options are safe and effective. hus, while essential basic infor"ation will be sought in




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parallel, NCCA8 is co""itted to the clinical study of pro"ising CA8 substances and "odalitiesbefore knowledge beco"es available about their active ingredients, "echanis"s of action,stability, and bioavailability.o help identify fertile areas for clinical investigation and the appropriate level of invest"ent inthese areas, the Center relies on evidence>based reviews described in Appendi0 TI/. heseanalyses indicate that infor"ation regarding the efficacy and safety of CA8 therapies spans acontinuu" ranging fro" anecdotes and case studies through encouraging data derived fro"s"all, well>developed Phase I and II clinical trials able &/.Basic Science Research. Ehile clinical research is the centerpiece of NCCA8=s researchportfolio, NCCA8 will pursue basic studies in parallel. he reali!ation that herbals are not singleagents but "i0tures of "any co"pounds "akes our understanding of their underlying"echanis"s of action all the "ore critical. 8oreover, research proOects such as those designed tounderstand the neurobiological basis for acupuncture>"ediated analgesia and the essentialco"ponents of +t. Hohn=s wort that a"eliorate depression "ay contribute to the knowledge baseof conventional bio"edical researchers and inspire novel treat"ent approaches and rational drugdiscovery. o take full advantage of the opportunities to build a base of CA8>related basicscience discoveries, rando"i!ed clinical trials will be designed not only to test treat"ents, butalso, to the e0tent possible, to deter"ine underlying "echanis"s of action, discover bio"arkers,define phar"acokinetics, identify the active co"ponents in natural products, and collect data onthe natural presentation and progression of the diseases under study. $or e0a"ple, NCCA8=s

current trial of Ginko !ilo!a not only will test whether this ancient natural product delays theonset and progression of de"entia, but the trial also represents the single largest prospectivestudy of intellectual decline in aging A"ericans to date.Colla!oration. he efficiency with which we advance our research agenda will be enhanced byleveraging the resources and e0pertise of our colleagues in other NI# Institutes and Centers,other govern"ent agencies, &'/ research institutions, the acade"ic and internationalco""unities, and industry. he opportunities for such collaborations are abundant and it isgratifying that we have already found "any partners at NI# and other agencies, and that centersof e0cellence throughout the world have e0pressed interest in working with us. 70panding#ori!ons Bf #ealthcare National Center $or Co"ple"entary And Alternative 8edicine $ive>Qear+trategic Plan )&>)- +epte"ber )-, ) /

Traditional Chinese Medi%ine

raditional Chinese 8edicines "ay be less affected than the phar"aceutical industry by EBaccession. Co"petition fro" other countries will place pressure on do"estic producers, but this ise0pected to have a beneficial effect in forcing the restructuring of the C8 industry, where no"anufacturer controls "ore than & percent of the "arket and there is no do"inant player. hiswill include establishing a scientific basis for the efficacy of herbal "edicines, which is i"perativeif China is to develop "edicines that confor" to international standards of @uality.

o increase co"petitiveness and "arket share, "any do"estic C8 industries have introducednew "edicines and increased the technology content of their products, transfor"ing theirproducts fro" traditional for"s of powder, "ass and s"all pills into capsules, tablets, syrup.

$ollowing EB "e"bership, the govern"ent has decided to nurture its own largephar"aceutical co"panies, particularly those producing raditional 8edicines, while reducing the

nu"ber of s"all co"panies. his is intended to boost the @uality of Chinese "edicine andenhance China=s ability to co"pete in world "arkets. he govern"ent is also pro"otingbusiness>to>business e>co""erce as a way of developing a nation>wide phar"aceutical"arketing network. Bver>the>counter sales have recorded very high growth in recent years, while retail outlets have"oved in the direction of large>scale and chained operation. 70pecting increased co"petitionfro" foreign players, "aOor local retail co"panies have e"barked on aggressive e0pansionprogra"s to sei!e the "arket before it co"pletely opens. o cope with the e0pected rise inco"petition fro" foreign players, the Chinese govern"ent reportedly plans to groo" five to ten

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"ega distribution enterprises with annual turnover a"ounting to 1- "illion, and < regionaldistribution enterprises with annual turnover a"ounting to 1)- "illion within the ne0t three to fiveyears. he li"ited scientific evidence about 8CA8Ms safety and efficacy as well as otherconsiderations "ake it i"portant for govern"ents to?$or"ulate national policy and regulation for the proper use of 8CA8 and its integration intonational health care syste"s in line with the provisions of the E#B strategies on raditional8edicines47stablish regulatory "echanis"s to control the safety and @uality of products and of 8CA8practice4Create awareness about safe and effective 8CA8 therapies a"ong the public and consu"ers4Cultivate and conserve "edicinal plants to ensure their sustainable use.SuggestionsAn earlier Exim bank study, finds renewed world wide interest in natural medicines

and newer cases in food and cosmetic industries, with good prospects for exports ofmedicinal plants from India. A favourable policy framework is required to promote

commercial cultivation, research and development, and increased exports ofmedicinal plants. The study adds that exports of finished products, rather than of

crude material, should be encouraged

Ehat is urgently re@uired is the change in attitude of scientists, traditional practitioners andindustry on one hand and the special policy initiatives by the %overn"ent on the other. hen onlycan we create the golden triangle of traditional "achine, "odern "achine and "odern science.Bn :uilding a %olden riangle between raditional 8edicine, 8odern 8edicine and 8odern+cience

;r. J. A. 8ashelkar, $J+;irector %eneral, C+IJ Y+ecretary to %ovt. of India;epart"ent of +cientific Y IndustrialJesearchNew ;elhi)-th 8ay, )2

$eferen%es

& ;e +"et PA%8 #erbal Je"edies N 7ngl H 8ed )) 2<(? )<F>-F