- 1. A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA A Final Term
Dissertation Work Submitted In Partial Fulfillment Of The Award Of
Degree of Master Of Pharmacy In Drug Regulatory Affairs &
Pharmaceutical Management To TO SCHOOL OF PHARMACEUTICAL SCIENCES
JAIPUR NATIONAL UNIVERSITY,JAIPUR SUPERVISED BY: Dr.Birendra
Shrivastava (Director Of Pharmaceutical sciences) Jaipur National
University Jaipur-Rajasthan SUBMITTED BY:- Avinash Sharma M.Pharm
IVth Sem. (DRA & PM)
2. CONTENTS Introduction Review of literature Objective
Regulatory registration procedure of nutraceuticals in India,
Canada and Australia Comparative study Case studies Summary &
conclusion Justification Plan of work References A COMPARATIVE
STUDY OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA 3. INTRODUCTION WHAT ARE NUTRACEUTICALS
Any substance that may be considered a food or part of a food and
provides medical or health benefits, including the prevention and
treatment of disease. It includes vitamins, minerals, herbs and
other botanicals, amino acids, and dietary substance for human use
as a supplement diet. A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 4. Definition INDIA: Food Safety and Standards authority
(FSSA) defines Nutraceuticals as Foods for special dietary uses in
India. CANADA: In Canada Nutraceuticals are known as Natural health
Products. Under the Natural Health Product Regulations. AUSTRALIA:
In Australia, traditional, herbal, natural and alternative
medicines and remedies are referred to as complementary medicines.
A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 5. TYPES 1. Based on
chemical constituents Nutrients Herbals Dietary Supplements 2.
Traditional and Non- Traditional Nutraceuticals Traditional
Nutraceuticals Nontraditional Nutraceuticals 3. Based on Diseases
Cancer Allergy Obesity A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 6. NUTRACEUTICALS: IN MARKET Fortified cereals: Various
cereals contain added vitamins and minerals. Vitamin and mineral
supplements: Either sold as separate or as mixture. Energy drinks
and tablets: Drinks contain stimulants such as caffeine and sugars
or isotonic drinks containing sugars and salts. Foods to reduce
cholesterol levels: ex. Benecol, Abcor Pro-biotics: ex. Yakult ,
Isotonix, . Florastor capsules (250 mg) A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 7. Nutraceutical in Indian Market Marketed
Nutraceutical Category Ingredients Manufacturer Threptin Diskettes
Protein supplements Proteins and vitamin B Raptakos, Brett &
Co. Ltd., Mumbai, India Proteinex Protein supplement Predigested
proteins, vitamins, minerals and carbohydrates Pfizer Ltd., Mumbai,
India Calcirol D-3 Calcium supplement Calcium and vitamins Cadilla
healthcare limited, Ahmedabad, India. Selltoc AC Nutritional
supplement Antioxidant Fourrts, India laboratories pvt. ltd Revital
Daily Health Supplement Ginseng, Vitamins and Minerals Ranbaxy,
India Multivite Woman Health Supplement Multivitamin, Essential
minerals, Amino acids Sanofi, India Hairbless tabletTM Dietary
Supplement Biotin, Niacinamide, Minerals & Amino acids Rivpra
Formulation Pvt. Ltd. 8. Marketed Natural Health Products Category
Ingredients Manufacturer Rhoziva Antioxidant, Immune Supplement
Rhodiola rosea Nanton Nutraceuticals Canada Salifert Coral Calcium
500 ml Health Supplements Calcium, Mg, Boron, Vitamin D, Minerals
Aquacave, Canada Vega - Maca Chocolate Dietary Supplement,
Antioxidant Meca, Vitamin B12, Mg, Ca, K, Iron Vega, Canada Zinc
Active Melt Immune booster Zinc, Lemon flavor Nutraceutical, Canada
Morning Rise & shine- 252gm Anti-fatigue, Health supplement
Vitamin C, Minerals, lemon Juice Powder, Aloe vera juice powder
Prairie Naturals, Canada Aller-7 Capsule Dietary supplements Zinc,
Polyphenol, Piperine, chebulic acid, Botenical extracts Nealanders
International Inc., Canada Organika Milk Thistle 250mg Dietary
supplement, detoxifier Milk thistle Seed (Silymarin) Organika,
Canada Nutraceutical in Canada Market 9. Nutraceutical in Australia
Market Marketed Complementary Medicine Products Category
Ingredients Manufacturer CENTRUM tablet Multivitamin, Mineral
supplement, Antioxidant Vitamins A, C, and E, Beta-carotene,
Selenium and Zinc Pfizer Australia Pty Ltd Elevit with iodine
tablet Multivitamin, Mineral supplements Vitamins A,B, C, D,E,
Calcium, Zn, Cu, Mg, Iodine Bayer Australia Ltd CALCI-TAB 600
tablets calcium supplement Calcium Carbonate AFT Pharmaceuticals
Berocca Performance tablet vitamin nutritional supplement
Combination of Vitamin B & C with added Calcium, Mg, Zn Bayer
healthcare Australia Ester-C 646mg tablets Antioxidants Calcium
ascorbate threonate complex Catalent Australia Pty Ltd FYBOGEL
ORANGE Effervescent Powder Fiber Supplement Betacarotene, Ispaghula
Husk Dry Reckitt Benckiser Pty Ltd Sumabe Glucosamine Supplement
Anti-fatigue, Immune supplements Glucosamine hcl chondroitin Sumabe
Holdings pty. Ltd. 10. Regulatory Act(s) and Issues of India,
Canada and Australia Country Regulatory act Regulatory issues India
The Food Safety and Standard Act (FSSA), 2006 The Food Safety and
Standard Authority of India (FSSAI), 2008 Manufacture, sell or
import of novel foods, GMF, functional food, nutraceuticals and
health supplements Canada Canadian Food and Drugs Act,2001 Natural
Health Product Directorate (NHPD), 2003 Describe foods with health
benefits Define nutraceutical Australia Therapeutic Goods Act 1989
FSANZ 1991 Regulation of CMs Develops food standards A COMPARATIVE
STUDY OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA 11. OBJECTIVE A Comparative study of
Regulatory Registration Procedure of Nutraceuticals in India,
Canada, Australia A COMPARATIVE STUDY OF REGULATORY REGISTRATION
PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 12. Food
Safety and Standards Authority of India http://www.fssai.gov.in/
(10-9-2012) In this section discussed about that The Food Safety
and Standards Authority of India has been established under the
Food Safety and Standards Act, 2006 as a statutory body for laying
down science based standards for articles of food and regulating
manufacturing, processing, distribution, sale and import of food so
as to ensure safe and wholesome food for human consumption. Natural
Health Products
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php (18-10-2012)
Under the Natural Health Products regulations, which came into
effect on January 1, 2004, natural health products (NHPs) are
defined as: A. vitamins & Minerals B. Herbal remedies C.
Homeopathic medicines D. Traditional medicines such as traditional
Chinese medicines E. Probiotics REVIEW OF LITERATURE A COMPARATIVE
STUDY OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA 13. Canada Health Claims on foods
http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/nutra-
funct_foods-nutra-fonc_aliment-eng.php (20-10-2012) In this
discussed about that All foods and drugs fall under the provisions
of the Food and Drugs Act and Regulations. Regulation of health
claims related to foods, including novel foods, is the province of
the Food Directorate of Health Canada, pursuant to the Food and
Drugs Act and Food and Drug Regulations and also of the Canadian
Food Inspection Agency (with regard to labelling and advertising).
Complementary Medicines
http://www.psa.org.au/download/Complementary-Medicines-v1.0.pdf
(10- 10-2012) In Australia, traditional, herbal, natural and
alternative medicines and remedies are referred to as complementary
medicines. Complementary medicines include herbal medicines,
vitamins, minerals and other nutritional supplements, Australian
indigenous medicines, traditional Indian medicines, traditional
Chinese medicines, homeopathic medicines and aromatherapy products.
A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 14. Food Standards
Australia & New Zealand http://www.foodstandards.gov.au/ Its a
bi-national Government agency. the main responsibility is to
develop and administer the Australia New Zealand Food Standards
Code (the Code), which lists requirements for foods such as
additives, food safety, labelling and GM foods. Enforcement and
interpretation of the Code is the responsibility of State/Territory
departments and food agencies within Australia and New Zealand.
Sarin Rajat et al (2012) In this discussed about that The term
Nutraceutical was coined from Nutrition and Pharmaceutical in 1989
by Stephen DeFelice. Drugs shows various side effects and adverse
effects due to which consumers are generally moves to take food
supplements to improve health. A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 15. Singh Jagtar et al (2012) Nutraceuticals are
medicinal foods that enhance health, modulate immunity and thereby
prevent and cure specific diseases. They may range from natural
diets, herbal products to genetically engineered foods and
processed products such as cereals, soups and beverages. Palthur M.
Prasad et al (2010) Nutraceuticals are a diverse product category
with various synonyms that are used internationally. Nutraceuticals
create an open environment for new products that promise novel
solutions to healthrelated issues. Nutraceuticals will play
important role in future therapeutic developments. A COMPARATIVE
STUDY OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA 16. Rajasekaran A et al (2008)
Pharmaceutical and nutritional companies are aware of the monetary
success taking advantage of the more health-seeking consumers and
the changing trends resulting in a proliferation of these
value-added products aimed at heart health to cancer. Some popular
nutraceuticals include glucosamine, ginseng, echinacea, folic acid,
cod liver oil, omega-3 eggs, calcium-enriched orange juice, green
tea etc. Basu k Saikat et al (2007) In this paper we examine
current nutraceutical and functional food literature from a
Canadian perspective to identify the potential for distinctive
niche markets and growth of the industry in Canada as well as its
potential contribution to international markets. A COMPARATIVE
STUDY OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA 17. Regulatory Authorities for
Nutraceuticals in India, Canada, Australia The Food Safety and
Standards Authority of India (FSSAI) FSSAI has been established
under Food Safety and Standards Act, 2006 which consolidates
various acts & orders that have handled food related issues in
various Ministries and Departments. FSSAI has been created for
laying down science based standards for articles of food and to
regulate their manufacture, storage, distribution, sale and import
to ensure availability of safe and wholesome food for human
consumption. A COMPARATIVE STUDY OF REGULATORY REGISTRATION
PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 18.
CANADA Natural Health Product Directorate (NHPD) The NHP
Regulations were implemented on January 1, 2004 by Health Canada.
NHPs, now a subcategory of drugs, are defined in the Regulations as
products such as vitamins, minerals, homeopathic medicines and
others. Health Canada (HC) Health Canada is responsible for
Establishing policies, setting standards and providing advice and
information on the safety and nutritional value of food. Canadian
Food Inspection Agency (CFIA) The Canadian Food Inspection Agency
(CFIA) is undertaking a review of its regulations for food safety,
plant and animal health to improve their consistency, reduce their
complexity and strengthen consumer protection. A COMPARATIVE STUDY
OF REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 19. AUSTRALIA Therapeutic Goods Administration
(TGA) In Australia, medicinal products containing such ingredients
as herbs, vitamins, minerals, nutritional supplements, homoeopathic
and certain aromatherapy preparations are referred to as
'complementary medicines' and are regulated as medicines under the
Therapeutic Goods Act 1989 (the Act). Food Standards Australia New
Zealand (FSANZ) Food Standards Australia New Zealand (FSANZ) is an
independent statutory agency established by the Food Standards
Australia New Zealand Act 1991. In Australia, food products do not
have to be submitted to any government agency before they are
supplied, but they must comply with the relevant standard of the
Food Standards Code, which covers aspects such as ingredient
safety, labelling and claims. A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 20. REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA 1. Regulatory Registration
Requirements in India A. Product Evaluation : Examination of each
active ingredient & additive. B. Licenses: To get Product
registered in India, number of licenses (almost 4 - 5) might be
required, depending on the actual product status. C. Health and
label Claims: Health claims means any representation that states,
suggests or implies that a relationship exists between a food or a
constituent of that food and health . A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 21. Health Claims: Health claims means any
representation that states, suggests or implies that a relationship
exists between a food or a constituent of that food and health .
Health claims can further be grouped into: 1. Nutrient function
claims 2. Other function claims and 3. Reduction of disease risk
claims. A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 22. Application for
Approval of New Product 1. Administrative information 2. Technical
information 3. Information on dietary exposure, nutritional impact
4. Efficacy-Health claim/Nutritional claim/Risk reduction claim 5.
Details of fees to be enclosed A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 23. Documents required for Registration/Licensing Form A
Application for Registration/Renewal of Registration Form B
Application for License / Renewal of license Form C License format
A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 24. 2. Regulatory
Registration requirements in Canada Natural Health Products
Regulations for Traditional medicines, Herbal remedies, homeopathic
medicines, vitamins, minerals, probiotics, amino acids and
essential fatty acids. A. Product licensing: A product licensing
system requires that all licensed products display a Product
identification Number prefixed by NPN/NPN-HM The number is issued
once a product is authorized for sale in Canada by Natural Health
Product Directorate. B. Evidence requirements for Safety &
efficacy: The safety and efficacy of NHPs and their health claims
must be supported by proper evidence C. Labelling: All NHPs must
meet specific labelling requirements, to help us make safe and
informed choices about the NHPs which are choosen to use. A
COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 25. D. Site
Licensing: A Site licence issued by the NHPD (Natural Health
Products Directorate) gives the licensee authorization to
manufacture, package, label and/or import NHPs. E. Good
Manufacturing Practices: The site to meet GMPs as per Natural
products Regulations. GMPs are to be employed to ensure product
safety and quality. F. Adverse Reaction Reporting: The Natural
Health Products Regulations require product licence holders to
monitor all adverse reactions related to their product. License
holders must report serious adverse reactions to Health Canada. G.
Clinical Trials: A clinical trial is when natural health products
are tested using human subjects. A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 26. Health Claims: a health claim for food is considered
to be any representation in labeling and advertising that states,
suggests, or implies that a relation exists between the consumption
of foods or food constituents and health. Types: 1. Specific health
claims: are claims about the effects of a food, or food
constituent, on a specific organ, disease, biomarker, or health
condition. There are 2 types of specific health claims: A. Disease
risk-reduction claims. B. Function claims. 2. General health
claims: are claims that do not refer to a specific health effect,
disease or health condition . A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 27. Natural Health Products Regulations have Provisions
for: A. Product Licensing B. Site Licensing C. Good Manufacturing
Practices D. Labeling and Packaging E. Adverse Reaction Reporting A
COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 28. 3. Regulatory
Registration requirements in Australia CMs in Australia are
regulated under the following legislation: Therapeutic Goods Act
1989 Therapeutic Goods Regulations 1990 (as amended) 1) Product
licensing: All CMs must be entered (on application to the TGA) in
the ARTG. Regulation is on the basis of risk. Products can be
either listed (low risk) or registered (higher risk). 2) Good
manufacturing practice: All products must be manufactured in
compliance with GMP. 3) Site licensing: The TGA licenses
manufacturers and audits GMP compliance. A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 29. 4) Labelling requirements: Registered
medicines (higher risk) are identified on the label by AUST R
followed by a unique number. Listed medicines (low risk) are
identified on the label by AUST L followed by a unique number. 5)
Post-market regulatory activity: The TGA takes a risk-based
approach to post- market surveillance. A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 30. Health Claims: Types 1. General level
claims: General level claims are claims where the manufacturer has
to make an assessment of the evidence supporting the claim prior to
the product going to market, and to hold the evidence 2. High level
claims:- High level claims are those claims which make reference to
a serious disease, including: Claims that refer to the potential
for a food or component to assist in controlling a serious disease
or condition. A COMPARATIVE STUDY OF REGULATORY REGISTRATION
PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 31.
COMPARATIVE STUDY OF REGULATORY REGISTRATION OF NUTRACEUTICLAS IN
INDIA, CANADAAND AUSTRALIA S. No. India Canada Australia Definition
FSSA define Nutraceutical as Foods for Special dietary use NHPD
define Nutraceutical as Natural Health Products TGA define
Nutraceutical as Complementary Medicines Rules/Regulations for
licensing and registration The Food Safety and Standards
Regulations Natural Health Products Regulations Therapeutic Goods
Regulations. Regulations came into force in year 2011 2004 1989
Responsible Regulatory authorities for Registration of
Nutraceuticals Food Safety and Standard Authority of India (FSSAI)
Natural Health Product directorate (NHPD), Health Canada
Therapeutic Good Administration (TGA) 32. Continued Regulatory
Requirements for Registration A. Product evaluation B. Licenses C.
Health & label claim A. Product licensing B. Evidence
requirements for Safety & efficacy C. Libeling D. Site
Licensing E. GMP F. Adverse Reaction reporting G. Clinical Trials
A. Product Application B. GMP C. Libeling D. Post-market
Surveillance 33. Continued Fees for registration Rs. 100 Currently
No fees required $AUS 720 Authorities for approval of claims FSSA
Health Canada FSANZ Health Claims 1) Nutrient function claim, 2)
Other function claims, 3) Reduction of disease risk claims General
Health Claims Specific Health claims General Level Health Claim
High Level Health claim A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 34. CASE STUDIES IN HEALTH FOODS Case Study 1. India Case
Study of Indian Organic farmers producer Company limited, Kochi,
Kerala Introduction This study analysed a case of indian organic
farmers producers company limited: (IOFPCL) based at Kochi, Kerala.
Triggering factor for formation of Producer Company: Members of
IOFPCL are basically dealing with organic farming of high value-low
volume commercial crops viz. pepper, cardamom, vanilla, coffee,
cocoa, etc Issues for future Consideration: the following issues
emerged for future consideration during case study of IOFPCL and
interactions with the primary producers. PPCs dealing with
agricultural commodities have to essentially focus on productivity
enhancement for creating marketing surplus . A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 35. Case Study 2. Canada DHA Milk Case Study -
Brain Development in a Glass This case examines DHA
(docasahexaenoic acid) milk in Canada, its origins and early
development and the policies and industry strategies that have
supported DHA milk from idea to retail sales. The case study also
points to some potential issues and areas for improvement.
Intellectual property and licensing agreements protect the rights
of product developers. Health Attribute Roles played by government
and policy Regulation Novel Food Approval Supply Management
Labelling A COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE
OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 36. Case Study 3.
Australia Complementary and Alternative Medicine (CAM) and cancer
user groups in the Australian context: A Case Study of an Oncology
Support Group in NSW. Proposed research activities Propose work was
planned to provide a self-contained case study of the meditation
group, and the research schedule was as follows: Pre-fieldwork
Post-fieldwork Specifically, data collection focused On:
Participant observation of group activities. Qualitative
interviews, both informal and semi-structured. Document analysis. A
COMPARATIVE STUDY OF REGULATORY REGISTRATION PROCEDURE OF
NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 37. SUMMARY From the
above dissertation work we have been enlighten with the Comparative
Study of Nutraceuticals Registration in different countries. Also
discussed about Nutraceutical definitions, types, Registration
Procedures for Nutraceuticals and Case Studies in India, Canada
& Australia. In India Nutraceutical known as Foods for Special
dietary use regulated & registered by FSSAI (Food Safety and
Standards Authority of India), In Canada they known as Natural
health products regulated and registered under NHPD (Natural health
product Directorate), in Australia they Known as Complementary
medicines regulated & registered by TGA (Therapeutic goods
Administration) A COMPARATIVE STUDY OF REGULATORY REGISTRATION
PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 38.
CONCLUSION Nutraceuticals are playing an important role in the
development of future therapeutics but it depends on the control of
purity, efficacy and safety. Hence, when any new Product/entrant
wants to enter in the Nutraceutical market of particular country,
it is very important to comply with the regulatory framework of
that country, so that the business is run smoothly. The focus areas
should be product evaluation for each active ingredient in the
context of permissibility, standards and dosage of
vitamins/minerals allowed, product classification as per various
healthcare laws (legal definition of the product), Country-specific
health & label claims and advertising. A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA,
CANADA AND AUSTRALIA 39. JUSTIFICATION The following key point are
enlightened to justify the authenticity of the disserted work.
Title :- The title of the proposed disserted work doesnt resemble
with any previous work. Significance :- The proposed work will give
the Information about Nutraceuticals, types, Market, Regulatory
Registration procedure of Nutraceuticals and comparative study of
Regulatory Registration procedure, Case studies in India, Canada
and Australia. Difference From The Work Done Till Now :- the work
done in the field are like review article on Nutraceuticals,
concepts, and Regulatory aspects. The difference between the work
is that the proposed disserted work will give a comparative study
of Regulatory Registration procedure of Nutraceuticals in India,
Canada and Australia. A COMPARATIVE STUDY OF REGULATORY
REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND
AUSTRALIA 40. Brief Information about Nutraceuticals and types of
Nutraceuticals Information of Nutraceuticals currently on Market
and study of Nutraceutical Market in India, Canada and Australia
Regulatory Registration Procedures of Nutraceuticals in India,
Canada and Australia Comparative study of Registration Procedures
of Nutraceuticals in India, Canada and Australia Case Studies in
Healthy foods PLAN OF WORK 41. http://www.fssai.gov.in/ 10-10-2012
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10- 10-2012 http://www.foodstandards.gov.au/ 10-10-2012
http://www.robert-forbes.com/our-services/foods.html 11-10-2012
http://foodsafetyhelpline.in/fssai/FAQ.asp?PL=GPArticles&GL=10
11-10-2012
http://pharmalicensing.com/public/articles/view/1020697759_3cd69c9fd2ab6
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