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 189 176
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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
176
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
, .
177
r-
,.
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
178
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.
179
••
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
180
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.
181
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.
182
I ,
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.
183
•
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
184
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.
185
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
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
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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