Chapter 7

Major findings and Conclusion

Sr.No.

7.1 Major Findings

Particulars Page No.

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7.1.1 The mode of exports 180

7.1.2 Exporting as Herbal Medicine or Supplement 181

7.1.3 Patent and Proprietary, OTe or Shastrokt 181

7.1.4 Knowledge and Understanding of the Technicalities for Export 182 of Herbal Medicines

7.1.5 Export Readiness 183

7.1.6 Market Potential 184

7.1.7 Ease of product registration 184

7.1.8 Profitability in Exports 185

7.1.9 Export revenue as percentage to total turnover of the business 185

7.2 Minimum Regulatory requirements (Guidelines for the 186 manufacturer of the Herbal Medicines): Imported herbal medicinal products

7.3 Guidelines on minimum requirements for the registration of 187 herbal medicinal products: Guidelines related to GMP for the Indian manufacture of Herbal medicines

7.4 Guidelines on minimum requirements for the registration of 188 herbal medicinal products: Guidelines related to quality control for the Indian manufacture of Herbal medicines

7.5 Product information 188

7.6 Issues and suggestions emerging out of the study 189

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7.6.1 Potential Markets for Indian manufacturer of Herbal Products I 189 medicines, from overall (all parameter put together) point of view

7.6.2 The ideal Strategy 190

7.6.3 Constraints faced in exports 190

7.7 Action Plan suggested at the company and industry association 191 level to increase exports

7.8 Ayurvedic Medicines: A summary of prospects and challenges. 192

7.8.1 Sunshine sector ISM 195

7.8.2 IPR in Traditional Medicines: Must not Neglect 197

7.9 Concluding Remarks 201

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Chapter 7

Major findings and Conclusion

Introduction:

Having elaborated historical aspects of the subject of this research work, i.e.

International Marketing potential of the Indian Herbal Medicines, in the beginning of

this thesis, the specific mention of 1) World history of Herbal Medicine, 2)lndian

History ISM and that of 3)lnternational Trading Structure of Pharmaceuticals and

issues are dwelt upon in the 151 Chapter. This is done with a specific idea of

providing intricate background to the subject and to the reviewer of this work.

Commonly used terms are explained, elaborated and summed up in the 2nd chapter

so as to personify the meaning the researcher has intended during the work or

writing of the thesis. Standard and also not so standard abbreviations are also

expanded in the 2nd chapter, as researcher might have taken some liberty of

abbreviating frequently re-occurring terms.

The detailed account of the published work, in the print as well as in the electronic

form, is thoroughly reviewed and relevant components are reproduced with the

intention to enlighten the reviewer with the previously published literature. Also was

intention to find out the gaps, as precisely as possible, in the body of knowledge in

the subject of this work, so as to attend and address it specifically. The search of the

literature, study of it and writing of the review, gave precious clarity which helped

frame the questionnaire and accrue exact information. The most relevant literature is

presented in the 3rd chapter, entitled Review of Literature.

Problem identification was thus the logical development. The rational of study,

Problem definition, Objectives of the study, significance of the study, expected

contribution through this study are developed in the 41h chapter known as Problem

Identification and Definition. It was observed that there is need for understanding of

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dynamics of the international trade of herbal products / medicines by the Indian

Manufacturer of Herbal Products. This include

• Export regulations

Country wise export regulations

• Regulatory approvals

Marketing Authorisation

• Product classification and definition differentiations

Packaging and labelling guidelines

Trade and Market set-ups

Pricing and logistics strategy

While framing the questionnaires, this was kept in mind and hence subsequently the

research work was carried out to answer these problems too.

Structure and method of the study was developed in a manner so as to attend the

problem in a very specific manner and arrive at the best possible solutions. The

research was carried out in two parts; in the first, the Indian manufacturers of Herbal

medicines were interviewed with a very specific questionnaire to understand their

current level of awareness, their preparedness for international market and also to

understand their difficulties and issues in exploring potential International markets; in

the second part international traders, importers or dealers were contacted to

highlight regulatory and marketing specifics required most by the Indian

manufacturers. Data thus collected are presented in the 6th chapter with due

analysis.

Based on the data generated through research, and its analysis, the summary in nut­

shall about the minimum requirements from regulatory clearance point of view to be

complied by the Indian manufacturer of the Herbal Medicines in order to get access

to the target International market are presented. This is not the most exhaustive list

of the requirements from the regulatory pOint of view but is the common minimum

requirement.

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Based on this research - the strengths, limitations, issues and awareness of Indian

manufacturer of herbal medicines as well as the regulations, opportunities and

requirements of the select overseas markets are accounted in detail.

On basis of the above understanding insights thus developed are processed for the

net decoction of this research work. In the final and vital component of this work,

constraints of manufacturer, steps needed at association and government level are

discussed as well as highlighted opportunities and challenges in reference to the

developments in the field of IPR. Thus the super-fine extract of this research project

is presented here under. It is humbly assumed that these stated net out-come shall

help policy makers, manufacturers, marketers, investors, farmers and people of India

at large.

7.1 Major Findings:

7.1.1 The mode of exports:

Direct export to the potential market is certainly more profitable 126compared to export

through the merchant exporter. The pros and cons of different mode of export can be

summarized as below:

DIRECT EXPORT MERCHANT EXPORT

Advantages of Direct Export

Better prici ng Lower pricing

Export incentives Loss of export incentives

Better Reputation No benefit on image

Better trade relation with importer No direct contact with importer

Advantages of Merchant Export

Export license requirement No need for license

Payment risk Minimal payment risk

Delayed payments Comparatively quicker payments

Administrative load Administratively simple

It has been observed that most manufacturing set-ups adapt merchant export route

initially, in the primitive stage of business whereas shifts to the direct export route

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over the period. Overseas manufacturing or manufacturing tie-ups are the most

advance form of international trade of herbal products. In this part of research, it was

observed that 70% of the manufacturers are as on date exporting their produce

through the merchant exporters and balance export directly. Only 6% of the

manufacturers have overseas tie-ups which is the most advanced mode of

international business. Because of such trend it can be safely concluded that Indian

manufacturer is still in a primary stage of international trade, if not primitive.

Also a point be driven here that the manufacturers' understanding of the dynamics of

·International trade, regulations of the international trade and his own relations with

the end-user and subsequently the consumer behaviour towards his products are far

below the potential level.

7.1.2 Exporting as Herbal Medicine or Supplement

Indian manufacturer is not exporting his produce as herbal medicine whereas prefers

to promote as either supplement, over the counter medicine or prefers to sell to the

Indian traditional medicine practitioners for their in-clinic consumption. This clearly

indicates his discomfort feature with the systematic and legal route of herbal

medicine. In this process to 'somehow push the product overseas', the Indian herbal

product manufacture's classification is incorrect, resultantly he settles with a smaller

segment and the non-profitable segment.

The research clearly shows that the majority of export is as supplement OTe and in­

clinic consumption. That means regulatory clearance as herbal medicine is yet a

distant dream of the manufacturer. At the same time it is obvious from this piece of

research that should he opt for the legal route, Indian manufacturer can capture

wider market share and obviously more creamer.

7.1.3 Patent and Proprietary, OTe or Shastrokt

Most players in the industry prefer to sell as OTe and least prefer to sell as Patent

and Proprietary. The regulatory by-pass is with OTe and profitability is with patent

and proprietary. With proper understanding of the regulations, Indian manufacturer

can opt for the better (bigger and profitable) trade route.

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7,1.4 Knowledge and Understanding of the Technicalities for Export of Herbal

Medicines:

When a fiddly question was asked whether you would want to know more about

various aspects of export of herbal medicines through seminar or workshop, most

respondent confirmed affirmatively. Regarding marketing dynamics, most

respondents unmistakably accepted the need for improving their understanding of

the subject. This piece of research points at great necessity of knowledge enhancing

seminars. The industries associations, export promotions councils, Ministry of

Commerce should take lead to organize targeted training sessions on topics such

as:

• Market sizes, Segments, Trends and Growth

• Marketing Authorizations norms of various countries

• Wholesale and Retail Trade and its dynamics

• Costs and variables of overseas market

• Institutional and Government purchase or tender systems

While talking to the respondents regarding export regulations and regulatory aspects

of product registrations, about 85% and 92% respondents, respectively, shown their

interest. This is a huge response clearly indicating requirements of a manufacturer

/marketer.

Cross-section on knowledge requirement:

Even across the sector for market dynamics, for export regulations, regulatory, and

legal aspects, for USA market 282 responses (respondents x parameters) were

received i.e. average 70% respondents were interested in acquiring knowledge in all

the four categories. Maximum response for USA was for export regulations and

minimum was for legal aspects. It is possible that exporter is more concerned about

exporting norms and regulations then the legal aspects.

For Russia, on an average 80% respondent wants to know about all the four

aspects, maximum for the regulatory and minimum for the legal i.e. 90% and 70%

respectively.

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The result clearly indicates the eagerness of the respondents to upgrade the

knowledge in almost all the areas identified during this study. This particular

phenomenon proves the hypotheses that current level of understanding and

knowledge of the exporter is not sufficient. The recommends, taking the lead from

this piece of outcome, that the industry associations, export promotion council, EXIM

Bank and various government nodal agencies, Government bodies, NGOs and all

concerned faculty should involved in knowledge enhancing activities such as training

programme, short term courses, workshops and seminars in this regard.

7.1.5 Export Readiness:

There are a few key requirements for exporting herbal products. When the

researcher tried to measure the export readiness of exporter, peculiar response was

observed. Less than Y. of respondent were having safety/toxicity data or efficacy

data with them. Similarly the local logistics details were also not available with most

exporters i.e. 74%. Less than 25% respondents were having idea about the local

competitions to their products in the targeted international market.

It can be safely concluded that on an average 50% of the respondents had no idea

at all of any of the product label claim requirements. 17.6% respondents on average

basis were not certain about the 11 parameters. Only 29% respondents on an

average were confident of having the data or source of data for 11 key requirements

or parameters.

Cross Analysis:

Out of all the 11 parameters, researcher did not receive optimum response for

safetyl toxicity data, heavy metal toxicity data, market authorization data and

advertising option data.

The most neglected parameter was Product efficacy data, wherein 66% respondent

had no data and 10% were not certain of what is it. Only 24% respondents

confirmed availability of this data for their produce. Similarly, 74% respondents were

not having labelling guidelines, which is a must for the International trade.

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The most affirmative response received was for heavy metal toxicity needs wherein

46% respondent conveyed availability .

This part of the research clearly indicates about the poor overall understanding of the

trade regulations and resultant clumsy approach to the business. It also highlights

dire necessity of information dissemination by the concerned government body,

export promotion councils or industry associations.

7.1.6 Market Potential:

The marketers have no doubt about the market potential of these countries.

However out of these 7 markets the best rated are USA, Russia and Malaysia. Of

course there are some very interesting success stories in Russian Federation of

Indian herbal products (i.e. Dr MOM herbal lozenges by Unique Pharmaceuticals) as

well as that of Himalaya Drug Company; there has always been a quest in Indian

exporter for the Russian market.

USA boasts of the biggest Pharma market of the world including the biggest market

for the herbal or natural supplements. The biggest ethnic minority in USA is Indians.

It is very much possible that most, if not all the manufacturer have some or the other

US connection and have had some success stories or the market potential talks.

Typically for UK and Germany i.e. both European countries respondents rated

comparatively low. Over all it can be said that respondents have fairly good idea

about market potential and are not in any illusion.

7.1.7 Ease of product registration:

The major hitch in systematic export of herbal medicine is product registration. The

regulatory requirements of various countries differ from each other to a considerable

extant, at the same time there is a good amount of similarity into documentary

requirements, since the basic objective of regulatory control are common i.e.

efficacy, safety, quality and at times pricing.

In this piece of survey it was observed that most respondents are finding this difficult

to break through. This requirement being mere a type of procedure, it can be safely

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interpreted as either unawareness of the procedure or prohibitive regulatory cost

responsible for manufacturer not being able to breakthrough.

This certainly calls for the industry association and Government involvement to

educate, intervene and subsidize the international product registration procedure of

the Indian exporter.

7.1.8 Profitability in Exports:

No exporters have any doubt about the profitability of their business in International

scenario. As in any other industry, in herbals too numbers of incentives are available

from the government for promoting exports. To name a few, exemption of excise

duty, Sales tax, duty free importation against export, subsidies on capital investment

towards export, relief in income tax on income generated from export etc.

Adds to this is the strong international currency and high cost of healthcare in

overseas markets, which allows Indian manufacturer to command better price for his

produce than the domestic segment.

For the larger picture, better exports mean prosperity of the Indian industry, more

investment and quality product ion. It also amounts to better economic picture for the

country with better foreign currency reserves and improvement in trade ratios.

7.1.9 Export revenue as percentage to total turnover of the business

The research suggests that for most of the manufacturers the export revenue is

dismally low compared to the overall business turn-over. This is despite the fact that

there is a great potential for the Indian Herbal pharmaceuticals in the International

context and better profitability.

The Indian manufacturer needs to focus on the International trade and gather

required knowledge to cross the barrier for far superior benefits for him self as well

as for the industry and the country at large.

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In the component above, the interpretation of the findings of this research work and

highlight of the key observations were summarized.

Out of the feedback received from the marketers, traders and the regulatory

personals of the select international market, the information about the key regulatory

requirements were gathered and are presented below.

7.2 Minimum Regulatory requirements (Guidelines for the manufacturer of the

Herbal Medicines): Imported herbal medicinal products

All imported herbal medicinal products intended to be registered need to meet

requirements of safety and efficacy and quality control regulation in importing

countries. In order to control the quality of imported herbal medicinal products, the

following requirements are taken into account:

• Licenses for importers, wholesalers and manufacturers of imported herbal

medicine products should be issued by the national health regulatory

authority

• Dealers in imported herbal medicinal products need to apply for one or more

of the licences depending on the type of business involved, such as

wholesale, and manufacture

• The onus of applying for an import licence is on the local company wishing to

import and sell herbal medicinal products in countries.

The following information related to the importing company is required to support an

application for an import licence:

• Details of company

• Particulars of person making application on behalf of company

• Certificate of company/business registration

• Store layout plan.

Importers are required to provide information on each imported herbal medicinal

product handled by them and will be allowed to deal only in products which are

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approved in the exporting countries. Detailed requirements for each imported herbal

medicinal product comprise:

• Full product formula (in languages of the importing and exporting countries)

• A set of labels, pamphlet, carton and specimen sales pack

• Particulars of manufacturer and assembler(s)

• Manufacturer's licence or certificate from health authority of manufacturing

country/origin.

• An export certificate for the herbal medicinal product if the product is

imported.

Based on the minimum requirements above, each national health regulatory

authority develops its own requirements for quality control of imported herbal

medicinal products.

7.3 Guidelines on minimum requirements for the registration of herbal

medicinal products: Guidelines related to GMP for the Indian manufacture of

Herbal medicines

All companies involved in the production and export of herbal medicinal products

should ideally adhere to the principles set out in the WHO guidelines for medicinal

products and GMP.

• Manufacturers of herbal medicines should be licensed and registered.

• The quality assurance system should be adequate and proportionate to the

type of production and the regional situation

• The implementation of a credible concept of quality assurance, e.g. identifying

and eliminating potential sources of contamination, rather than implementing

all individual technical aspects, should be the primary goal.

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7.4 Guidelines on minimum requirements for the registration of herbal

medicinal products: Guidelines related to QC for the Indian manufacture of

Herbal medicines

In view of regulatory officials, the basis for quality control is the establishment of

appropriate specifications and standards. I nformation on appropriate standards can

be found in official pharmacopoeias and monographs. In choosing analytical

methods, the availability and robustness of the method must be considered by the

Indian manufacturer. It may be preferable to use simple methods such as

microscopic identification, thin-layer chromatography or titration of active substance

if a full validation of more sophisticated methods such as high-performance liquid

chromatography, gas chromatography and gas chromatography/mass spectrometry

is not possible. If such advanced methods are used, a full validation for each test is

necessary.

7.5 Product information

The product information should include all necessary information on proper use of

the product. The following elements of information are usually included:

• Brand name of product

• Quantitative list of active ingredients, including plant names, part of plants

used (i.e. Latin name)

• Dosage form

• Indications

• The minimum, maximum and average dosage levels must be stated (if

appropriate, specify for children and pregnant women dosages)

• Mode of administration

• Duration of use

• Adverse effects, where applicable

• Over-dosage information

• Contraindications, warnings, precautions

• Drug interactions, where applicable

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• Date of issue

• Expiry date of product

• Lot I Batch number

• Name of manufacturer or company with full address

This was summary in nut-shall about the minimum requirements from regulatory

clearance point of view to be complied by the Indian manufacturer of the Herbal

Medicines in order to get excess to the target International market. This is not the

most exhaustive list of the requirements from the regulatory point of view but is the

common minimum requirements.

Based on this research - the strengths, limitations, issues and awareness of Indian

manufacturer of herbal medicines as well as the regulations, opportunities and

requirements of the select overseas markets are accounted in detail in previous part.

On the basis of the understanding and the insight thus developed are processed for

the net decoction of this research work. In the final and vital component of this work,

constraints of manufacturer, steps needed at association and government level are

discussed as well as highlighted opportunities and challenges in reference to the

developments in the field of IPR. Thus the super-fine extract of this research project

is presented here under. It is humbly assumed that these above stated net out-come

shall help policy makers, manufacturers, marketers, investors, farmers and people of

India at large.

7.6 ISSUES AND SUGGESTIONS EMERGING OUT OF THE STUDY

Having seen in great details in the previous chapters, the opportunities and

limitations of the Indian Herbal product manufacturer the same is summarized as

below:

7.6.1 Potential Markets for Indian manufacturer of Herbal Products I medicines,

from overall (all parameter put together) pOint of view:

Most Potential:

• Russia

• Malaysia

• Canada

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Next Best Potential:

• Germany

• USA

• UK

• Japan

7.6.2 The ideal Strategy:

• Label herbal products as "Health Supplements" to get started. Switch to

Medicines as soon as competency for the regulations developed

• Study, design and implement packaging to International standard and put only

just required copy matter by the local regulations, respective to the country

• For best profitability, tie-up with only importer/distributor; keep marketing

(including pricing decisions) with self, this helps improve profitability

• Appoint country manager to monitor sales and business activities instead of

leaving it to the importing party. This way one will have constant updates

about the policy and regulation modification in the target market.

• Understand local advertising, and brand promotion options before deciding

your action plan

7.6.3 Constraints faced in exports:

• Market information available regarding the importing country, its regulations

pertaining to Herbal Medicines / products and trade structure is either not

available or is incomplete and scattered.

• It is difficult and expensive to locate right trading partner for Ayurvedic and

Siddha products in the International market, which can break the barriers of

the Regulatory Offices, Import regulations and market adversities.

• Most manufacturers are trying to sell herbal products as OTe medicines or

prescription medicines, where as it is comparatively easy to sell as Herbal

supplements and cosmetics in many countries from regulatory pOint of view.

• Indian manufacturers have very little experience in the herbal cosmetics and

nutritional supplement markets. Hence changing their product profile

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according to the needs of the international market poses a challenge at the

same time huge potential.

• Due to some of the above limitations, Indian manufacturers in specific and

Government of India in general, are not able to tap the true potential of the

mighty Indian System of Medicine; resultantly there is a huge gap in the

potential (for export and foreign revenue collection) and actualization.

7.7 Action Plan suggested at the company and industry association level to

increase exports:

• Association or Government or export promotion council need to educate

Indian manufacturer on Regulatory aspects for the target markets such as

Malaysia, US, Japan, and Russia.

• Networking abroad for making trade contacts

• Lobbying with various Ministries of Health and regulating bodies to improve

Ayurveda's acceptance and lower regulatory barriers

• Getting in touch with the Indian consulate/embassy to seek their guidance in

entering the respective markets

• Negotiating with foreign agents for marketing tie-ups

• Setting up joint ventures to build plants/manufacturing units abroad with the

latest technology

• Sending trained Ayurvedic practitioners who could render the treatment

abroad in collaboration with qualified doctors of modern medicine there. (M/s

Maharishi Yogi has successfully explored this model)

• Exploring other avenues, especially the cosmeceuticals segment. But this

requires considerable inputs from modern technology and could perhaps be

an inhibiting factor if not able to match the quality expectations.

• The industry associations should insist their case with the Government to

sponsor representatives from the industry to international seminars and

workshops for presentations on ISM.

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• A film on Ayurveda, its strengths and case studies, should be made for

telecast, by industry associations in conjunction with the Government. Also

can be screened at various International platforms.

• The firms/association should lobby with the Government for more support, tax

incentives and tax holidays for the industry.

7.8 AYURVEDIC MEDICINES: A SUMMARY OF PROSPECTS AND

CHALLENGES

With the global trend of "back to nature" fast catching up, there is an increased use

of herbal medicines as complementary and alternative medicines. At the national

level, traditional medicine is popular and is accepted and used by most of the

population (as mentioned before, WHO estimates that 80% of the world population

uses at least one form of traditional medicine). It is the most accessible and

affordable treatment option for the poor and people in remote areas. During the last

decade, there has also been a growing interest in traditional and alternative systems

of medicine in many developed countries.

We have seen it before that 1/3 of American adults have used alternative treatment

and 60% of the public in the Netherlands and Belgium. and 74% in the United

Kingdom are in favour of complementary medicine being available within the

framework of the National Health Service. As per the feedback from a local

enterprise dealing with Indian Ayurvedic products in Norway, it is estimated that the

Norwegian market for natural remedies is around 2 billion Kroner (approximately INR

10 billion) at the retail level. This is 20% of the total medicines sold in Norway and

almost the same amount as non-prescription Allopathic medicine. The market for

natural products in Norway has been growing at a rate of 12% per annum with

Ayurvedic products having a market share of around 10 million Kroner at the retail

level.

A survey among member countries of the European Union in 1991 identified about

1400 herbal drugs used in the European Economic Community.

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However, there are certain limiting factors that have inhibited the expansion of the

Traditional Indian products beyond a limit. The major restraining factors are:

1. Limited quality assurance of traditional medicine

2. Efficacy proof of most traditional medicine therapies are not based on clinical

trials

3. Limited advanced research facilities / activities

4. Lack of qualified or properly trained ISM practitioners across the globe

5. Limited acceptance of traditional medicine by the modern healthcare

professionals

6. Ignorance of stakeholders about intellectual property rights and hence lack of

preventive protection

Realizing the importance of traditional medicine in the healthcare system, as

well as its role as a complementary medication, the use of intellectual property

rights should be seriously and systematically promoted among stakeholders.

Efforts should be made for a generic model for patent or other related intellectual

property rights law as well as for an international agreement, to support the health

sector at the national level, and to develop a national law. In this context, developing

a national traditional medicine policy is imperative.

This national traditional medicine policy must include:

• The issues of R&D, QC & QA in the area of traditional medicine,

• The formal recognition of traditional medicine systems and

• The integration of traditional medicine in the national health care system

It is generally agreed that countries should have a national policy on traditional

medicine as part of the national health policy and that they should develop and utilize

traditional medicine in a meaningful manner in the national healthcare system. For

this, organizational infrastructure of traditional medicine should be developed and/or

strengthened. Traditional medicine is culturally, economically and geographically

accessible. Traditional Medicines have tremendous export potential and hence

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scope for earning foreign revenue. Therefore, the role of traditional medicine in the

healthcare system and in countries economy is indispensable. In view of this, the

following measures can be fruitful:

• International, National and regional strategies should be developed for the

protection of traditional medicines, may be with the support of WHO and other

international agencies

• Ways and means required to be devised and customary laws to be

strengthened to protect traditional medicine knowledge of the community from

bio-piracy

• Simultaneously, efforts through technical cooperation among countries can be

made to add value through innovation.

• Traditional knowledge, which is in the public domain, needs to be documented

in the form of traditional knowledge digital libraries (as mentioned previously,

India has initiated the TKDL which is expected to be online very shortly). Such

information needs to be exchanged and disseminated through systems or

mechanisms relating to intellectual property rights

• However, documentation of traditional knowledge (i.e. TKDL) serves

defensive purpose, i.e., prevention of patenting of traditional knowledge in the

form in which it exists. But by itself, it will not facilitate benefit sharing with the

stakeholders of this traditional knowledge. There is a need to provide

institutional support to investigate, sustain and scale up grass-root innovations

and to enhance technical competence and self - reliance of these innovators

and manufacturers.

• WHO, in cooperation with other agencies including UNCTAD, needs to

support the initiatives taken by governments of various countries for capacity

building, implementation and enforcing the legislation to protect and promote

traditional medicine knowledge through. International cooperation needs to be

increased in this area

• A compulsory curriculum on law related to traditional medicines should be

introduced in the educational system so that the students are able to

understand the technicalities of the IPR issues and the protection is easily

available to the innovators.

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• Our government should develop guidelines or laws and enforce them to

ensure benefit sharing with the community for commercial use of traditional

knowledge

• Efforts should be made to utilize the flexibility provided under the TRIPS

agreement with a view to promoting easy access of traditional medicine for

the healthcare needs of various countries

7.8.1 Sunshine sector ISM

As has been indicated earlier, the use of natural products is on the rise throughout

the world. This phenomenon needs to be capitalized upon by the Indian Ayurveda

and Siddha manufacturers. This is especially so for countries like Nepal, Sri Lanka,

UAE and Hungary etc, who have recognised Ayurveda officially as a medical

system. This recognition of Ayurveda as a complimentary and alternative medical

system is a milestone for the propagation of Ayurveda abroad.

The experiences of Ayurveda practitioners indicate that there is a huge potential for

exports of such products and services, especially in afore mentioned markets. The

herbal drugs market in the UAE is estimated at up to Dh 300 million annually. The

popularity of Ayurveda can be gauged from the fact that 60% of Ayurveda clientele in

UAE are local Arabs. This success is despite the lack of awareness of Ayurveda and

Siddha systems amongst the locals. If Ayurveda and Siddha can be propagated as

part of life in countries that officially recognize these medical systems, then it would

wide-open up doors for unprecedented exports of Ayurveda and Siddha, particularly

product and services exports. This is where the concept of 'medical tourism' needs to

be leveraged.

Ayurveda and Siddha products and services should encompass the following:

• The developed nations follow a discriminatory practice through restrictive

medical legislation for all natural medicines produced by companies outside

Europe and North America. Hence it is imperative to identify a mechanism to

counter such restrictive practices giving due considerations to the provisions

of the World Trade Organisation

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• Ayurveda and Siddha products have to be subjected to the globally accepted

processes such as Randomized Double-Blind Controlled Clinical Trials as

formulated by the WHO, so as to convince importing countries to accept their

efficacy and safety

• A few diseases like HIV I AIDS, cancer, hepatitis, diabetes, psoriasis, leprosy,

leucoderma, muscular dystrophy, osteoporosis, benign prostatic hyperplasia,

and arthritis should be selected and put on the WHO protocol based

controlled clinical trials. The results should then be published in international

medical journals. If the preliminary results are confirmed and accepted, then

Ayurveda and Siddha medicines used in the trial would be in demand globally

and the desired exports of such products would then occur. Since Ayurveda

and Siddha physicians are necessary to initially introduce the treatment

abroad, the export of their services would also take place simultaneously

• Identifying Ayurveda and Siddha related intellectual properties and creating

rights over them so as to facilitate exports in the long run. These medical

systems should be given a strong base of IPRs in order to develop overseas

markets for their products and services. The traditional knowledge should be

claimed as such and authoritative records should be created in its favour to

prevent bio-piracy . The TKDL initiative taken by the government ( Ministry of

health and family welfare, Department of AYUSH) is a progressive step in this

direction. But the work in developing this digital library needs to be expedited.

• Alternative sales techniques, especially sales via the internet (e-commerce)

need to be explored. According to Nutrition Business Journal, dietary

supplement sales on the internet reached US$ 40 million in 1998, an increase

of US$ 12 million over 1997 figures. The rate of sales growth for supplements

on the internet far exceeds those of natural foods and mass- market stores,

and of multilevel marketing as well. Cashing on this trend requires launching

good quality portals on Ayurveda and Siddha products and services.

However, the working culture of the Ayurveda and Siddha clan has not yet

caught up with the web and net culture. Systematic, subject-wise websites

must be designed not just to disseminate information on the Indian systems of

medicine to the world but also explore opportunities of e-commerce.

196

• A vertical network starting from cultivation and collection of medicinal plants

and raw drugs, passing through Ayurveda and Siddha medical research, drug

development and International business needs to be created

• Ayurveda and Siddha products and services should be included as an

identified export item and should be incorporated in the Exim Policy

7.8.2 IPR in Traditional Medicines: Must not Neglect

Protection of intellectual property comes under the ambit of the World Intellectual

Property Organisation (WI PO). Within WI PO's work on traditional knowledge,

traditional medicine is probably the foremost area driving the intellectual property

agenda. This is especially true for Asian countries where the ancient systems of

traditional Chinese medicine and Ayurvedic medicine are found.

Many activities and products based on traditional knowledge are important sources

of income. Traditional technologies and innovations, which are by their very nature

adapted to local needs, can provide a viable and environmentally sustainable path to

economic development. Access to genetic resources and the associated traditional

knowledge can provide substantial benefits to companies and scientific research

centres in both developed and developing countries. However, there is concern that

traditional knowledge is sometimes appropriated, adapted and patented by scientists

and industry (often from developed countries) with little or no compensation to the

custodians of this knowledge and without their prior informed consent.

Government of India should rally their concern for a fair and equitable sharing of

benefits. It was observed during the interaction with Indian Manufacturers that at

present, there is no agreement on what would be the most appropriate and effective

way to achieve the goal of a fair and equitable sharing of the benefits derived from

technologies and innovations based on traditional knowledge by both developing and

developed countries.

It is also mentioned in WHO's "Report of the Inter-Regional Workshop on Intellectual

Property Rights in the Context of Traditional Medicine", (WHOfTRM/2001), presently,

the requirements for protection provided under international standards for patent law

197

and by most national patent laws are inadequate to protect traditional knowledge and

biodiversity. For example, traditional skills in manual and spiritual therapies are

different from those in modem practice and there is no record of the inventor.

Similarly, other traditional non-medication therapies are very difficult to protect using

current standards of patent protection.

While knowledge from ciassicalliterature is documented and hence not amenable for

the gain of exclusive patent rights, the undocumented and unpublished knowledge

from traditional healers and ethnic communities can be easily used and products

developed from them given exclusive patents to the pharmacy that develops the

drug. Modern patent law extends legal protection to those ideas that are revealed in

their entirety to the public and therefore lie beyond the limits of secrecy. By granting

time-limited exclusive rights to the inventors once they have disclosed their ideas,

patents ensure benefits for innovators while at the same time ensuring that the public

gets access to the ideas.

Existing conventional patent law can and does protect pharmaceutical products.

However, herbal medicines and herbal products are different from chemical drugs.

The intellectual property standards established by the Agreement of Trade-Related

Aspects of Intellectual Property Rights (TRIPs Agreement, 1994) allows innovation to

be protected by the discovery of new chemical components, know-how in producing

the product, trademarks and trade secrets. However, TRIPs does not allow for a

mechanism to ensure repatriation of benefits to those who have knowledge of

properties of medicinal plants. The agreement obliges member governments to

provide for "the protection of plant varieties either by patents or by an effective sui

generis system or by any combination thereof." The existing IPR systems are

oriented around the concept of private ownership and individual innovation. While

recognising the market-based nature of IPRs, other non-market based rights could

be useful in developing models for a right to protect traditional knowledge, innovation

and practices.

The same Report states that for herbal medicines, it is difficult to meet all the

requirements of patentability due to their intrinsic characteristics. Herbal medicines

are crude plant materials, such as leaves, flowers, fruits, seeds, stems, wood, bark,

198

roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.

As such, it is often not possible to obtain existing patent law protection for herbal

medicines by claiming the discovery of new chemical entities, which are novel,

involve an inventive step and are industrially applicable. Secondly, herbal products

are powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials

prepared by production processes, which are usually simple. There is no know-how

or invention in the preparation process that is sophisticated enough to justify

protection under existing patent laws. Thirdly, except for pharmaceutical companies

and industries, other holders of traditional knowledge, such as research institutes

and practitioners, often do not have the financial and human resources that are

necessary to obtain protection through trademarks. Fourthly, it is extremely difficult, if

not impossible, to keep knowledge a secret, because disclosure of the composition

of the product is a prerequisite for registration of herbal medicines before the product

can be sold. Last, but not the least, it is very expensive to acquire, exercise and

enforce patent rights in most countries, particularly if international coverage is

required.

The cost is prohibitive for traditional practitioners and research institutions,

particularly in our country. The intellectual property needs of traditional healers

include, inter alia, the prevention of the acquisition of intellectual property rights over

traditional medicine by its documenting and publication as searchable prior art, a

reassessment of what constitutes prior art for purposes of patent examinations, the

testing of options for the collective management of intellectual property rights by

traditional healers' associations, a study of customary laws which protect traditional

medicine in local and traditional communities, testing the applicability of the present

intellectual property system for the protection of traditional medicine, facilitating

access to the intellectual property system for traditional medicine practitioners, legal

and technical assistance with the documentation of traditional medicine, and

awareness-raising as to the role of intellectual property protection in relation to

traditional medicine.

Certain existing intellectual property rights may provide a degree of protection to

practitioners of traditional medicine. This can be exemplified through experiments

that some grass root organizations had undertaken to collectively file patent

199

applications and acquire other intellectual property rights on behalf of traditional

medicine practitioners. WIPO, in cooperation with UNEP, undertook an "On- site

Documentation Project on the Role of Intellectual Property Rights in the Sharing of

Benefits Arising from the Use of Traditional Knowledge and Associated Biological

Resources", This project produced three case studies which WI PO and UNEP jOintly

submitted to the fifth Conference of the Parties to the Convention on Biological

Diversity in May 2000. According to this report, the effective protection of intellectual

property is a necessary condition for generating benefits that will be subject to

benefit sharing, but it is not a sufficient condition, Several additional measures are

needed to supplement the role of intellectual property rights in benefit sharing over

biological resources and traditional knowledge.

The problem areas and gaps in relation to patent protection in the context of

traditional medicine and traditional medicine knowledge are summarized below:

• Lack of a national policy to develop traditional medicine and lack of

organizational infrastructure to utilize traditional medicine in the national

healthcare system

• Absence of formal or informal mechanisms for the participation of traditional

product manufacturer in policy making and intellectual property development

• The importance and prioritization of traditional medicine has not been fully

recognized and explicitly mentioned by various international health

organizations

• Lack of policy and regulations for the protection of biodiversity and knowledge

of traditional medicine

• Lack of understanding of intellectual property rights system among

stakeholders specifically farmers who cultivates, tribal who at time collects,

processors, manufacturers and marketers.

• Lack of mechanism for developing linkages between traditional medicines of

different countries

Differences between the concepts and fundamentals of traditional medicine and

modern medicine

200

Inability to meet the cost of requiring, exercising and enforcing intellectual

property rights for the holders of traditional medicine knowledge

7.9 Concluding Remarks:

Against this backdrop of the opportunities that exist, in Ayurveda and Siddha, it's a

sunshine sector for Indian Economy. It is imperative that a strategy needs to be

evolved so as to take advantage of the bright prospects that these Indian systems of

medicine have to offer. This work was initiated and carried out with these thoughts in

the mind.

There were ample evidences throughout the work that there is an upsurge in the

demand level of herbal products, nationally and intemationally. It only needs to be

recognized and frame strategy to explore for much larger profits to the individual

manufacturer, recognition to the Industry and foreign revenue and respect to the

country. It is sincerely hoped that the research outcome will specifically help achieve

these objectives.

The strategic points evolved here for the Indian manufacturer, the industry

association, the export promotion councils and the government shall be useful for the

overall up-liftment of the trade, industry and country's economy so as to benefit the

common man of the country,

The whole-world is a big market place in itself. It wasn't possible within the frame of

this research work to explore the other markets, which may prove to be equal or

more potential then the markets explored in this study. More detailed exploration is

required to map country specific strategy of the un-explored markets.

This humble work, if achieves a fraction of the purpose stated ahead, it will be a

meaningful and worthwhile contribution to the vast and ever growing body of

knowledge.

********

201

,

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Bibliography:

Various published and/or on-line material used as citation and also indirectly

for developing insight on the subject is enlisted hereunder.

• Natural Ingredients for Pharmaceuticals, EU Market Survey 2001, CBI,

Netherlands

• Natural Ingredients for Cosmetics, EU Market Survey 2001, CBI, Netherlands

• Natural Ingredients for Pharmaceuticals, EU Strategic Marketing Guide, 2000,

CBI, Netherlands

• Natural Ingredients for Cosmetics, EU Strategic Marketing Guide, 2000, CBI,

Netherlands

• Report from the Ad Hoc Working Group on Herbal Medicinal Products, 1997-

98, The European Agency for the Evaluation of Herbal Plants

• Directive of the European Parliament and of the Council amending the

Directive 2001/83/EC, as regards Traditional Herbal Medicinal Products,

Commission of the European Communities

• Herbal Medicinal Products in the European Union, The Association of the

European Self-Medication Industry

• Health Trends and Profiles of the Future Herbal Consumer, Strategic

Information Services Unit, Alberta Agriculture Food and Rural Development

• New Pharmaceutical, Nutraceutical and Industrial Products - The Potential for

Australian Agriculture, Rural Industries Research and Development

Corporation, November 2000

• Commission on Macroeconomics and Health Working Paper Series, Paper

No. WG 4: 4 -Protection of Traditional Medicine, July 2001

• The Association of the European Self-Medication Industry - 37th Annual

Meeting -"Access to Self-Care The Revolution is Here" Special Conference

Report, Rome, June 2001

• WHO Drug Information Vol. 14, No~4, 2000

• General Guidelines for Methodologies on Research and Evaluation of

Traditional Medicine -WHO/EDMITRM/2000.1

202

• Guidelines for the Assessment of Herbal Medicines, WHOfTRMI 91.4,

Programme on Traditional Medicines, WHO, Geneva, 1991

• WHO Policy Perspectives on Medicines, No.2 May 2002 - Traditional

Medicine: Growing Needs and Potential, WHO, Geneva

• Proceedings of WHO Centre for Health Development - International

Symposium on Traditional Medicine, Japan, September 2000

• Prevalence of Use of Complementaryl Alternative Medicine: A Systematic

Review, Bulletin of the World Health Organisation, 2000

• Regional Consultation on Development of Traditional Medicine in South-East

Asia Region -Report of a Regional ConSUltative Meeting, New Delhi, 14-17

September 1999

• WHO Traditional Medicine Strategy, 2002-2005, WHO/EDMI TRM/2002.1

• Report of the Inter-Regional Workshop on Intellectual Property Rights in the

Context of Traditional Medicine, Bangkok, Thailand, 6-S December 2000,

WHO/EDMfTRM/2001.1

• Regulatory Situation of Herbal Medicines: A worldwide Review,

WHOfTRM/9S.1, WHO, Geneva

• Draft National Policy on Indian Systems of Medicine, Department of Indian

Systems of Medicine and Homoeopathy, Ministry of Health and Family

Welfare, 2001

• Protection of Traditional Medicine, Indian Council for Research on

International Economic Relations, December 2000, Working Paper No.66

• White House Commission on Complementary and Alternative Medicine

Policy, Final Report, March 2002

• Assessing The Impact of Trade Liberalization on the Conservation and

Sustainable Use of Agricultural Biological Diversity, Secretariat for the

Convention on Biological Diversity, Montreal, January 2002

• Compilation and Overview of Existing Instruments, Guidelines, Codes and

other Activities Relevant to the Programme of work for the Implementation of

Article S(J) and Related Provisions, Montreal, Convention on Biological

Diversity, February 2002, UNEP ICBDIWGSJ/2/1NF 11

• Proceedings of International Seminar on Medicinal Plants and Spices -

Patents and Exports, VHERD, Chennai, April 2002

203

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• Proceedings of International Seminar on Medicinal Plants - Quality

Standardisation, Chennai, VHERD, June 2001

• Feasibility Report on Ayurvedic Medicines, ITCOT, Chennai, 2001

• Directorate General of Commercial Intelligence and Statistics, Ministry of

Commerce

• Journal of American Medical Association, Various Issues a British Medical

Journal, Various Issues

• Nutrition Business Journal, Various Issues

• Inputs from Indian Missions in London, Moscow, Frankfurt and Geneva

204

Annexure 1: Traditional Medicine: WHO Definition

Traditional medicine includes diverse health practices, approaches, knowledge and

beliefs incorporating plant, animal and/or mineral based medicines, spiritual

therapies, manual techniques and exercises, applied singularly or in combination

to maintain will-being, as well as to treat. diagnose or prevent illness.

Commonly used therapies and therapeutic techniques

Chinese Ayurveda Unani Naturopathy Osteopathy Homeopathy

Medicine

Herbal • • • • .:. • medicines

Acupuncture I • .:. acupressure

Manual .:. • • 0 • therapies

Spiritual • • • • therapies

Exercises .:. . :. .: .

• = Commonly incorporates this therapy / therapeutic technique

.:. = Sometimes incorporates this therapy / therapeutic technique

o = Incorporates therapeutic touch

Chiropractic

•

205

Annexure 2:

Questionnaire 1:

Objective: To learn about the specific issues faced by the Indian

Manufacturer/exporters of herbal medicines towards the regulatory and registration

aspects in the field of International Market.

Respondent profile: Manufactures, their export managers and the merchant

exporters

Sample size: Small, Medium and Large Manufacturer. Total number 50

Operative: Through personal or tele-interview

A. Respondent

Company Name Respondent's Name

Graduate PG PhD Others (PI. Specify

Respondent's Education CEO/COO Sr. Middle Others (PI.

Manaaement Manaqement Sfl"cify) Respondent's Position

Engineering Science Medicine / Management Others (PI. & Technical Herbal Specify)

Medicine Respondent's Speciality Date of Response

Post E-Mail Tele-Interview Personal Interview

Mode of Response

How do you export? Directly or through merchant exporter?

Export No Mostly, No Not Certain Mostly, Yes Yes

Direct

Merchant

Overseas manufacturinq / tie-up

Herbal medicine or as something like health / food supplements?

Market Route No Mostly, No Not Certain Mostly, Yes Yes

Herbal Medicine

Health/Food Supplement

Over the counter medicine

Used by Indian TM practitioner Used by Medical Practitioner

206

•

In following countries your herbal products are exported as Shastrokt or Patent and Proprietary?

Sr Country Patent and Proprietary OTC Generic I Shastrokt

No. USA Russia UK Canada Japan Malaysia Germany'

Interested in educational seminars on the subjects of International Marketing would you participate?

Countries Market Size, Export Product Legal Aspects Stricture, Growth Regulations Registration

USA Russia UK Canada Japan Malaysia Germany

Do you have sufficient information about the regulations?

Information Availability Not Mostly Not Not Certain Mostly Available Available Available Available

SafetylT oxicity data needs Efficacy data needs Heavy Metal Toxicity needs Market Authorization Regulatory Logistics Market size and strength Labelling guidelines Trade Structure Local competition Advertising options

Country Specific Market Potential

Zones No Potential at all Least Potential Not Sure Potential Highly Potential

USA Russia UK Canada Japan Malaysia Germany

207

Ease of Registration / Regulation

Zones No Potential at all Least Potential Not Sure Potential Highly Potential

USA Russia UK Canada Jaoan Malaysia Germany

Profitability point of view

Zones No Potential at all Least Potential Not Sure Potential Highly Potential

USA Russia UK Canada Japan Malaysia Germany

Out of your current business, what percentage would be your export?

<25% 25-5-% 50-75% >75%

Questionnaire 2:

Objective: To get information about the regulations, registration procedures and

market structure for the herbal medicines/products in select world market.

Respondent profile: An importer or a distributor of Herbal medicines of the selected

overseas market.

Sample size: At least 5 respondents per country

Operative: Through e-mail via some reference contact.

A] Questionnaire 2:

1. Name the laws, regulations or acts governing herbal medicine business /

trade in your country.

208

•

Name of the Law/AcUOrder In force since Purpose

Example: Magical Remedies Act of India 1970 To prevent tali Ifalse claims

medicinal products

1

2

3

4

5

2. Name any additional Law/ActlGovt-Administration order that controls import of Herbal Medicines.

Name of the Law/AcUOrder In force since Purpose

1

2

3

4

5

3. Please mention which all documents out of the following are required for the

registration of Herbal Medicines.

Sr# Name of the Document 'v ' or type yes where Remarks:

ever applicable. (e.g. Legalization

of

or

notarization if required,

Language of dossier

etc)

e.g. ISO 9001:2000 Yes

1 GMP

2 WHO-GMP

3 COPP (Certificate of Pharmaceutical

Product)

4 Free Sale Certificate

5 Certificate of Analysis

6 Method of Analysis of Active/non-

active ingred',ent

7 Reference standard of Active

ingredient

209

Sr# Name of the Document ',j , or type yes where Remarks:

ever applicable. (e.g. Legalization or

notarization if required,

Language of dossier

etc)

8 Manufacturing Process Flow-chart

9 Manufacturing Site license !Certificate

10 Registration details in other countries

11 Formulation details

12 Raw material Sample (qty in grams?)

13 Finished Product Sample (Quantity?)

14 Label!carton

15 Prescribing Information

16 Heavy Metal Analysis

17 Pesticidellnsecticide Analysis

18 Clinical data of Active ingredients (i.e.

published data is valid?)

19 Clinical trial of finished product (n-?)

20 Safety and Toxicity data

21 Bio-equivalence and Bio-availability

studies

22 Real time Stability data

23 Accelerated stability data

24 Any Other: Please specify

4. Can you please give some idea about market structure I Value of medicines in

your country, by putting approximate percentage in appropriate column? (If

possible also mention source of information)

Category Rx Non-Rx OTC Supplement Others Market Value Total

(US$)

Allopathic! 100%

Modern

Medicine

Herbal! 100%

Traditional

Medicine

210

5. Please give name and address of the document/office that approves import

and trade of Herbal Medicines in your country.

6. Can you please narrate in the flow chart below, the stages of Registration

procedure!

Activity Yes/No Normal Sequence Fees/Charges Remarks,

(Applicability) Time (Please rank /Expenses ifany

Frame the priority) (US$)

Pre-submission

product inspection

Dossier

Submission

Translation

submission

Analytical testing

Fees payment

intimation

Site visit / factory

inspection

Registration

Finalization

Re-registration I

Renewal

Others

7. Is there any specific labelling guidelines or requirements for the herbal

Medicines? Can you please suggest the regulation?

211

Labelling Guideline Applicability (Yes/No) Remarks, if any

Is Product Composition necessary on Active Ingredients

the label/Carton? Inactive

Is Patient's information insert a must?

Language on Labell Carton I Insert: Local English Both

Label

Carton

Insert

Indications:

Product benefit I Advantage

Expiry date:

Best Before:

Or any other format

Generic product Name

Latin:

International:

Bar Code

Nutritional Values

Manufacture's license number

Halal Logo

Others

Others

8. Would you suggest some contact, publication or website, which can provide

further details on this subject?

Reference For information on Registration of Herbal Products

Person or Office

Publication

Website

212

BJ Respondent Profile:

1. Name:

2. Age:

3. Sex:

4. Education:

5. Contact Details/e-mail:

6. Profession/Business:

7. No. of years in the current profession:

8. Your Complete contact details:

a. Address:

b. Tel/Fax No.:

c. E-mail address:

d. Web Site:

9. Current Business Turnover:

10. Your Position in the Organization: Please Tick-mark at appropriate box.

Your Position Please put' where appropriate

1. CEO/COO

2. Sr. Management

3. Middle Management

4. Others( PI Specify)

213

Annexure 3: Names and Web Link of Ministries of Health, World Wide

r· 1. European Community

• Finland (Social- och Halsovardsministeriet) • France (In French) • Holland (Ministry of Health, Welfare and Sport) • Ireland (Department of Health) • Luxembourg (Ministre de la Sante - In French) • Great Britain (Department of Health) • Swe3en (Social Department) • Germany (Bundesministerium fUr Gesundheit - in German)

2. Other European Countries

• Malta (Ministry of Health, Care and Family Affairs) • Norway (Social and Health Department) • Russia (Public Health Institute) • Tjekkiet (Ministry of Health) • Hungary (Ministry of the Interior)

3. Asia Minor and the Middle East

• Forenede Arablske Emirater (Ministry of Health) • Israel (Ministry of Health) • Jordan (Ministry of Health) • Turkey (Ministry of Health)

4. North America

• Canada (Health Canada) • Ontario (Ministry of Health and Longer Term Care) • USA (Department of Health and Human Services)

5. South America

• Chile (Ministerio de Salud - In Spanish) • Columbia (Ministerio de Salud - In Spanish) • Costa Rica (Ministerio de Salud - In Spanish) • Guatemala (Ministerio de Salud - In Spanish) • Mexico (Secretario de Salud - In Spanish)

6. Africa

• Kenya (Ministry of Health) • Marocco (Ministene de la Sante Publique - In French)

214

7. Asia

• Philippines (Council for Health Research and Development) • Hong Kong (Social Welfare Department) • Indonesien (Ministry for Health) • Japan (Ministry of Health and Welfare) • Malaysia (Department of Public Health) • Thailand (Ministry of Public Health) • Taiwan (Department of Health)

8. Australia and The Pacific

• Australien (Commenwealth Department of Health and Family Services) • Guam (Department of Public Health & Social Services) • New Zealand (Ministry of Health)

215

Annexure 4: Basics of Good Manufacturing Practices (GMP)

• GMPs (usually referred to as cGMPs, which stands for current Good

Manufacturing Practices) are mandated by FDA.

• Medical product companies (companies producing drugs and medical

devices) that do not adhere to GMPs are subject to legal action under the

auspices of the Federal Food, Drug, and Cosmetic Act

• The Act and related regulations, such as the GMPs, were developed over

time as the government responded to various public health crises caused by

unsafe or ineffective medical prod ucts.

• FDA's charge, and the purpose of GMPs, is to ensure that medical products

are safe and have the "identity and strength and meet the quality and purity

characteristics" that they are purported or represented to possess.

• The GMPs are a quality assurance system that requires control of the drug (or

device) production process from the time materials (excipients, actives, and

packaging and labelling materials) are received at the plant, through

production and testing, and into the commercial market place.

• Support systems such as employee training, quality assurance review and

release of product, etc., are also required. The requirements of the GMPs are

published in the Federal Register, but these are general and represent the

minimum requirements around which a company should construct its own

very specific quality program.

• FDA has certain expectations as to what must be covered and how matters

must be handled to meet the requirements of GMP, depending on the type of

product manufactured and the current state of the art in a particular industry.

• FDA expects manufacturers to remain current in the state of the art of

manufacture, testing, and packaging of their products, usually referred to as

cGMP.

• Interpreting the generalities and remaining current is where the GMPs can get

complex, and training and experience are needed to be able to consistently

meet FDA's expectations.

• The GMPs require thorough documentation. In FDA's eyes, if it is not

documented, it did not happen or does not exist

216

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• Every procedure must be committed to writing and reflect the actual operating

practices at the company. All critical steps in the process must be controlled

and recorded in a detailed manner.

• Critical processes including manufacturing, cleaning, and test

methodologies -- must be validated with documented evidence that they

consistently perform their intended function such that the result of the process

meets pre-determined quality attributes.

• FDA conducts routine and special inspections of manufacturers to determine

if the company is operating in a state of compliance with cGMP requirements.

217

Annexure 5: IMS Data' - Market size of Pharmaceuticals and trend, of major

international markets

Following is the sales through the retail pharmacies, country wise, continent wise, in

12 months ended to April 2005. The change over previous similar period is

expressed as %, alongside the gross values, which is in US$ .

• NORTH AMERICA $188.7 billion, up 7% o United States $177.8billion. up 7% o Canada $11.0billion, up 10%

.EUROPE (leading 5) $89.0billion, up 4% o Germany $26.1 billion, up 5% o France $22.0billion. up 4% o United Kingdom $15.8billion. up 4% o Italy $14.5billion, up 0% o Spain $10.7billion, up 6%

.JAPAN (including hospitals) $59.2biliion, up 2%

• LATIN AMERICA (leading 3) $14.0biliion, up 13% o Mexico $6.7billion, up 11 % o Brazil $5.4billion, up 18% o Argentina $1.9billion. up 10%

.AUSTRALIA/NEW ZEALAND $5.4biliion, up 7%

(*12 months ended to April 2005)

218

Annexure 6: Abbreviations

Abbreviations used in the text throughout this thesis are summarized for the ease of

the reviewer. The same are presented in alphabetical order and not as per the

occurrence.

AESGPI

AVP

AVS

AYUSH

BADs

BAMS

CAM

CBD

CCRAS

CIMAP

CITES

CMAAC

CPhA

CPMP

CSIR

CSM

DIN

eCTD

EC

EMEA

ESCOP

FDA

FRIM

GATS

GATT

GMP

HM

HMPWP

Association of the European Self-Medication Industry

Arya Vaidya Pharmacy

Arya Vaidya Sala

Ayurveda, Unani, Siddha and Homeopathy

Biologically Active Dietary Supplements

Bachelor in Ayurveda Medicine and Surgery

Complementary and Alternative Medicine

Convention on Biological Diversity

Central Council for Research in Ayurveda and Siddha

Central Institute of Medicinal and Aromatic Plants

Convention on International Trade in Endangered

Species of Wild Fauna and Flora

Chinese Medicine & Acupuncture of Canada

Canadian Pharmaceutical Association

Committee for Proprietary Medicinal Products

Council of Scientific and Industrial Research

Committee on Safety of Medicines

Drug Identification Number

electronic Common Technical Dossier

European Community

European Agency for the Evaluation of Medicinal Products

European Scientific Cooperative on Phytotherapy

Food and Drug Administration

Forest Research Institute of Malaysia

General agreement for the trade and services

General Agreement on Tariffs and Trade

Good Manufacturing Practices

Herbal Medicines

Herbal Medicinal Products Working Party

219

HPB Health Protection Branch

ICDRA International Conference on Drug RegUlatory Authorities

ICMR Indian Council of Medical Research

IMCC Indian Medicine Central Council

IMF International Monetary Fund

IND Investigational New Drug

IPC International Patent Classification

IPR Intellectual Property Rights

ISM Indian System of Medicine

ISM&H Indian Systems of Medicine and Homeopathy

It ITC (HS) International Trade Classification (Harmonized System)

KAPL Kerala Ayurveda Pharmacy Limited

KFC Kerala Financial Corporation

KIRTADS Kerala Institute for Research, Training and Development

of Scheduled Castes and Scheduled Tribes

KSIDC Kerala State Industrial Development Corporation

KTDC Kerala Tourism Development Corporation

MA Marketing authorisation

MADRC Malaysian Adverse Drug Reaction Committee

MAS Modern Allopathic System

MCA Medicines Control Agency

MFA Multifibre Arrangement

MHC Malaysian Herbal Corporation

MHRA Medicines and Herbal products Regulatory Agency

MIGHT Malaysian Industry-Government Group for High Technology

MFN Most Favourite Nations

ML Manufacturer's License

MNC Multi National Corporation

MOH Ministry of Health

MoU Memorandum of Understanding

MTN Multinational Trade Negotiations

NBRI National Botanical Research Institute

NIC Newly Industrializing Countries

NOC No Objection Certificate

220

NWFP Non Wood Forest Produce

PPM Parts Per Million r RCH Reproductive and Child Healthcare

RIRDC Rural Industries Research and Development Corporation

RD Registration Dossier

RRL Regional Research Laboratory

R&D Research and Development

SDM Shoppers Drug Mart

SPC Siddha Pharmacopoeia Committee

TBGRI Tropical Botanic Garden and Research Institute

TCM Traditional Chinese Medicine

THM Traditional Herbal Medicines

THMRS Traditional Herbal Medicine Registration Scheme

TKDL Traditional Knowledge Digital Library

TM Traditional Medicines

TSM Traditional System of Medicine

UNCTAD United Nations Conference on Trade and Development

WHO World Health Organisation

WIPO World Intellectual Property Organisation

WL Wholesale dealer's License

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