major findings and conclusion -...
TRANSCRIPT
Chapter 7
Major findings and Conclusion
Sr.No.
7.1 Major Findings
Particulars Page No.
180
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$)
Allopathic! 100%
Modern
Medicine
Herbal! 100%
Traditional
Medicine
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5. Please give name and address of the document/office that approves import
and trade of Herbal Medicines in your country.
6. Can you please narrate in the flow chart below, the stages of Registration
procedure!
Activity Yes/No Normal Sequence Fees/Charges Remarks,
(Applicability) Time (Please rank /Expenses ifany
Frame the priority) (US$)
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
r
• 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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