AYURVEDA IN EURO= PE : HURDLES, CHALLENGES AND WAY FORWARD

Chandra Kant Katiyar

Director, Herbal Drug Resea= rch

Ranbaxy Laboratories Ltd.

Gurgaon-122 001, India

chandra.katiyar@ranbaxy.com

INTRODUCTION:

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Ayurveda= is a centuries old comprehensive science of life. It is not merely a system of medicine. Ayurveda recommends measures on ho= w to attain healthy and active life for more than hundred years. For this purpos= e it recommends the use of both therapeutic and non-therapeutic measures, major focus being on diet, behavioural modalities and material-medica. Yoga is an integral part of Ayurve= da. Ayurveda has withstood onslaughts = of several cultures for centuries in India and not only managed to survive but also has crossed the transnational boundaries, a fact which den= otes its inherent strength. Today it is knocking at the doors of the western countries including Europe and US. In th= e last few decades Ayurveda has become more popular in Euro= pe along with Yoga and has caught everybody’s attention.

Its time= for EU to recognize the fact that Ayurveda is an entirely independent medical knowled= ge system having its own identify, recognition, presence, theories, practice etc. Hence it should not be treated on par with many other sys= tems which are prevailing in Europe as many o= f them depend upon Western science whereas Ayruveda has its own strong background, philosophy, science and principles .

AYURVEDA IN EUROPE:

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Perspect= ives of Ayurveda in Europe should be viewed under the fol= lowing four dimensions:

-&nb= sp; Education

-&nb= sp; Practitioners

-&nb= sp; Practice

-&nb= sp; Drugs

All of t= hese components have their own issues and challenges. Due to increasing awareness of Ayurvedic products in general and dem= onstrated success of some of the Ayurvedic practices it has gained entry into Europe. Today there are several medical institution= s teaching Ayurveda courses both degree and diploma, outside India, including UK. However, the courses being taught = are not aligned with India, the parent country of Ayurveda. The recognition of these degrees imparted by these institutions is also a subject of debate in India. Course contents, durat= ion of course, practical demonstration, availability of the hospital with sufficie= nt number of beds etc add more to the issues to be resolved. All these issues need to be discus= sed at appropriate fora, which will help in promoting Ayurveda education in Europe.

Regardin= g practitioners, Europe has hundreds of practitioners of Ayurveda which are practicing under the umbrella of herbal medicinal practi= tioners and also have their associations. There is no register atleast in UK for providing legal status to these practitioners. This resulted into several categor= ies of practitioners in Europe, which if not co= ntrolled, in the coming times, may create embarrassing situations in not too distant future. There is need, theref= ore, to have minimum eligibility criteria for registration of Ayurveda practitio= ners in Europe. There is also a need of CMEs for t= hese practitioners.

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Pancha karma has become very popul= ar among Europe especially for chronic debi= litating disorders like arthritis. It = has become so popular that Indian institutions like Arya Vaidya Sala in Kerala = have long queue of European patients to be treated with this Ayurveda therapy. Unfortunately, few people have red= uced this comprehensive pancha karma therapy to only massage therapy or = shirodhara, for their convenience. This t= rend is not good for the system of Ayurveda and needs to be tackled earnestly so that the use of whole of pancha kar= ma therapy spreads more and more and finally it become more popular beyond mas= sage therapy which provides external massage while pancha karma provides internal cleansing method as well.

The benefits of yoga today = have been appreciated through out the world and Europe is no exception. Unfortunatel= y, the case of pancha karma and massage therapy discussed above, is true for yoga also. Lot of centres are mushrooming in the name of Yoga which are providing different k= inds of exercises along with therapies including relaxation therapy. Yoga in fact is a distinct discipl= ine that goes beyond exercise and it needs to be promoted in entirety rather th= an in distorted forms.

Ayruveda uses three kinds of products to provide health promotion, maintenance and management:-

diet
the products which act both as drug and diet, l= ike spices, and
the drugs

Ayurvedi= c drugs are made from medicinal plants, minerals, metals or from the substances of anim= al origin. However, large propor= tion of these Ayurvedic medicines is made from herbs. The Ayurvedic medicines cover almo= st 100 types of dosage forms out of which, almost 50 types are still in popular use. These dosage forms range= from juice of plants to powder of the dried material to self fermented herbal products (asava arishtas) to me= tallic bhasmas (calcined metals by spe= cific Ayurvedic processes) etc.

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THMPD AND ITS IMPACT:

As a con= sequence of Lord Walton Committee’s report on Science & Technology, MHRA (formerly MCA) initiated consultations with stake holders which resulted finally in European Directive called Traditional Herbal Medicinal Products Directives (THMPD). This dire= ctives was an amendment of Pharmaceutical Directive 2001/83/EC.

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An effort has been made to anayse the impact of this Directive on Indian Ayurvedic Industry in Table 1.

Table 1

Analysis of the impact of the THMP= D (Amending The Directive 2001/83/EC)

As Regards Traditional Herbal Medicinal Prod= ucts

AR= TICLE	RE= MARKS	CO= NCERN
Article 1 Gives definition of traditional herbal medicinal products, herbal medicinal products, herbal substances and herbal preparations.	No remarks as only definitions have been given	Definitions are app= ropriate
Chapter 2a, Article 16a= A simplified regist= ration procedure (hereinafter “traditional use registration”) is her= eby installed for herbal medicinal products which fulfil the following criter= ia :- a) &nbs= p; they are indicated exclusively for indications adapted to a traditional herbal medicinal product, which by virtue of its composition and purpose, is intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. b) &nbs= p; They are exclusively for administration in accordance with a specific strength. c) &nbs= p; They are an oral, external and/or inhalation preparation d) &nbs= p; The period of traditional use as stipulated in Article 16C (1) ( c) has elapsed. e) &nbs= p; The data on the traditional use of the medicin= al product is sufficient, in particular the product proves not to be harmful= in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long term use and experience.=	This article puts f= ive conditions to make a product eligible for traditional use registration	Point No.d is matte= r of concern.
*Art= icle 16c* 1) &nbs= p; referred to in Article 8(3) (a) to (h) (j) and= (k) 2) &nbs= p; the results of pharmaceutical tests referred t= o in the first indent of article 8(3) (I) 3) &nbs= p; the summary of product characteristics without= the data specified in article 11(4) 4) &nbs= p; In case of a combination, as referred to in Ar= ticle 1(3), the information data referred to in Article 16a (e) relating to the combination as such. If the individual active ingredients are not sufficiently known, the data need a= lso relate to the individual active ingredients	The application sho= uld be accompanied by the documents including those mentioned in Article 8(3) as enumerated below : a) &nbs= p; Name or corporate name & permanent address= of the applicant & where applicable, of the manufacturer. b) &nbs= p; Name of the medicinal product c) &nbs= p; Qualitative & quantitative particulars of = all the constituents of the medicinal product in usual terminology, but exclu= ding empirical chemical formulae, with mention of the international non- proprietary name recommended by the World Health Organization where such = name exists. d) &nbs= p; Description of the manufacturing method e) &nbs= p; Therapeutic indications, contra-indications and adverse reactions. f) &nbs= p; Posology, pharmaceuticalform, method and route of administration and expected shelf life g) &nbs= p; If applicable, reasons for any precautionary a= nd safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, togeth= er with an indication of any potential risks presented by the medicinal prod= uct for the environment. h) &nbs= p; Description of the control methods employed by= the manufacturer (qualitative & quantitative analysis of the constituents= and of the finished product, special tests, eg sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests, controls carried out at an intermed= iate stage of the manufacturing process) i) &nbs= p; Results o= f : - &nbs= p; physico-c= hemical, biological or microbiological tests. - &nbs= p; Toxicolog= ical and pharmacological tests - &nbs= p; Clinical = trials	a) &nbs= p; Article 8(3) includes the results of toxicological, pharmacological and clinical trials are to be submitted as part of the dossier for registration. <= o:p> b) &nbs= p; WHO document No.WHO/EDM/TRM/200.1 says only when there is no documentation= of long historical use of a herbal medicine or when doubts exists about its safety additional toxicity studies to be performed. Even WHO has not given cle= ar cut period as to what shall constitute a long term use.= c) &nbs= p; These documents are not in conformity with the intention of the direct= ive to provide easy registration process to traditional herbal medicine products= . d) &nbs= p; In fact = article 8(3) (i) this clause does n= ot differentiate between a conventional medicine and traditional herbal medicinal products. e) &nbs= p; Article 14(3) referring Homeopathic drugs of t= he Directive 2001/83/EC dated 6^th November, 2001 says “ The proof of therapeutic ef= ficacy shall not be required for homeopathic medicinal products registered in accordance with paragraph 1 of this article, or where appropriate, admitt= ed in accordance with article 13(2)”. f)= If th= ere is no provision to provide proof for efficacy the same arguments, should be applied to traditional herbal products as well.<= /span>
Article 16c (4) If the product has = been available within the community for at least 15 years, the applicant may supply evidence of medicinal use throughout a period of time, which compl= etes the period of 30 years in a specified territory or territories outside the community.	Availability of the= product in European community for atleast 15 years and a total of 30 years outside the territory appears too long	- &nbs= p; This may = be treated as non tariff trade barrier.&nbs= p; - &nbs= p; Out of the total Ayurvedic products exported the share of purely herbal classical ayurvedic products is negligible and = in most of the cases P&P ayurvedic products are exported. While in case of classical ayurv= edic products evidence of 30 years of use outside territory can be provided bu= t 15 years use in European community countries may be difficult to get. - &nbs= p; In case of P&P ayurvedic products both the periods 30 as well as 15 years appear= too long. - &nbs= p; The Europ= ean commission directive 16c (1) C and 16c (4) are a bit confusing and would work against innovation. - &nbs= p; It should= be suggested that 15 years of use in European countries should be deleted altogether and 15 years of use in countries of origin should be allowed to make the products eligible for registration under this amended EC Directi= ve.

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Ayurvedic products are proposed to be covered under THMPD. While European commission = insists the condition of 15/30 years use, Indian Govt. continues to request to aban= don it and debate and discussions on this issue continue at different fora.

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It is to= be noted that Hungary started providing registration to Ayurvedic products as para medicine, a ca= tegory falling between dietary supplement and drugs few decades ago. Impact of THM= PD on such products which, already have been registered as Para medicine needs to be debated. Whether the category of Para medicine can continue in Hungary<= /st1:country-region> in parallel to THMP is a question which needs to be addressed appropriately. Wide ranging debate on this issue = may lead to rethinking on the THMPD itself.

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The major impact/ issues arising out of THMPD can be classified into two categories of (a) Non Tariff Barrier (NBT) a= nd (b) Technical Barriers to Trade (TBT).=

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The THMPD creates a new classification of Traditional Herbal Medicinal Products (THMP) with the provision of pharmaceutical registration for specific herbal medic= inal products. However, the direct= ive provides this exemption with several conditions like having been safe use for 30 years out of it 15= is a must in EU member country. Th= is means all the herbs which are not meeting the criteria of 15 years use in EU still have to comply with full product regime under pharmaceutical directiv= e. The important point noted here is = that Homeopathy have been given the exemption when it comes to submitting the data on safety and efficacy.

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The cond= ition of 15/30 years, the efficacy and safety etc, besides heavy fee for dossier submission fall under the categor= y of NBT.

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Some of = the issues which can be considered as TBTs include:

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Preparation of Monographs on Indian medicinal plants – Currently EU has very few Indian medicinal plants in their list of monographs. Increasing the number of these monographs wi= th EU will enhance the probability of export as this will act as a facilitator and will be treated as documentation of use.

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Safety and efficacy data – In case= the product does not meet 15/30 years requirement, the data on efficacy and safety generated and submitted with even bibliographic references sometimes may be of use. But the acceptability of the data thus genera= ted is doubtful. This is because of lack of harmonized and mutually acceptable and feasible guideline for evaluation of safety and efficac= y of THMPs.

3. Preparation = of list of herbs under different categories- Currently there is no &= nbsp; uniformity among EU member countries on identification of plants with high risk, low risk and GRASS list. In t= he absence of uniformity, even if one registers a product in one country, the other country may still reject merely basis their own &nb= sp; list of plants.

4. Acceptance of Pharmacopoeia- While India accepts the British Pharmacopoeia &nb= sp; for pharmaceuticals, this is the right time to ask EU to provide official reco= gnition to Ayurvedic Pharmacopo= eia of India and Ayurvedic Formulary of = India and it would then facilitate fast track registration under THMPD.

5. GMP requirem= ents – Currently, to the best of my knowledge, India does not have &nbs= p; more than a couple of Herbal/Ayurvedic manufacturing units which &= nbsp; comply with the EU= GMP requirements, or even latest GMP requirements on Dietary = S= upplements published by USFDA. The GMP inspection in such cases usually ta= kes &= nbsp; place on product to product basis. Considering current low volume export bus= iness &= nbsp; by Indian companies, few companies may pool their resources and with adequate subsidy from Govt. of India, come up with EU GMP compliant Ayurvedic/Herbal &nbs= p; product manufacturing unit. Any party should be allowed to manufacture their = ; product on loan license or third party = basis. Govt of India would have to request EU &nbs= p; authorities to accept the = ; products thus manufactured.

6. Genot= ox and Bio-assays - It is strongly felt that requirement of genotoxicity data = and bio-assays of = ; ingredients in poly herbal formulations has apparently resulted in low &= nbsp; number of &nbs= p; applications for traditional use registration. Insistence on &nbs= p; quantitative deter= mination (bio-assays) in poly he= rbal compounds is = technically not feasible for &n= bsp; any poly herbal formulations having more than 3-4 ingredients. Further insistence on genotoxicity &nb= sp; data without any hazard = assessment indicates the = ; disproportionality of the Directive.

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WAY FORWARD

Ayurveda= is well established science of life expanding beyond the concept of system of medic= ine. It has been providing the hea= lth benefits to India for centuries. Some of the aspects of Ayurveda like Pancha karma, Shirodhara and Yoga have recently entered the wes= tern countries and are becoming quite popular.&= nbsp; However, this constitutes very small part of Ayurveda. In order to provide the benefits of Ayurveda as a whole to Europe a lot of m= easures will be required and some of which are enumerated below:

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Education:

Developm= ent of proper curriculum in consultation with Government of India, alignment of duration of course, hours of teaching, course content, practical training a= nd sometimes exchange of students and faculty are few of the measures. Beside this inclusion of Ayurveda = under formal education programme at University level would add lot of value in Europe.

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Practitioners:

First of= all, Ayurveda should be recognized as the system of medicine distinctly different from herbalism. Ayruveda prac= titioners should be provided legal status by proving them registration and fixing min= imum eligibility criteria. There s= hould be CME programme in consultation with Govt. of India for the same.

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Practices:

Though A= yurveda practice like pancha karma and = Yoga have become popular, there needs p= roper hospitals so that these practices can be provided in a more systematic manner. Establishment of ayur= vedic hospitals having all the treatment facilities including pancha karma and Yoga should be encouraged rather than establis= hing only massage centres in the name of pancha karma or shirodhara. Some s= ystem of grading of services can also be considered .

Ayurvedic medicines

The above mentioned issues with regard to THMPD need to be addressed on top priority = at the highest level between Govt. of India and EU. Immediate measures can be,

1. <= /span>Extending the time of implementation of THMPD

2. Eliminate or defer 15/30 years use requirement

3. Continue discussions on mutually acceptable te= rms and conditions of trade on Ayurvedic medicine between India a= nd EU

4. Inclusion of the experts from India in THMPC.

5. = Accepting Ayurvedic Pharmacopeia of Indian and Indian Pharmacopoeia besides the monographs published by Indian Council of Medical Research as official documents for the purpose of including them in the positive list so that the products made out of these herbs should also get the same treatment as the = ones made from the ingredients falling under the positive list.

6. Extending all the exemption provided to Homeopathic medicines, to Ayurvedia medicines also, should be considered.

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If the a= bove are implemented the benefits of Ayurveda can be provided to the population of E= uropean Union in a more organized manner.

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As Regards Traditional Herbal Medicinal Prod= ucts

Article 1

Chapter 2a, Article 16a=