This document presents a comparative study of the regulatory registration procedures for nutraceuticals in India, Canada, and Australia. It provides an overview of the relevant regulatory bodies and acts that govern nutraceuticals in each country. In India, nutraceuticals are regulated by the Food Safety and Standards Authority of India under the Food Safety and Standards Act. In Canada, they are defined as natural health products under the Natural Health Products Directorate. And in Australia, they are referred to as complementary medicines and regulated by various acts and standards organizations. The study reviews literature on nutraceutical definitions, types, markets and regulations in these three countries.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
DIETARY SUPPLEMENT
The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases.
Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take.
It is a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid.
A dietary substance use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
FDA Role
Companies can often introduce a dietary supplement to the market without notifying FDA.
FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace.
If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market.
FDA regulates both finished dietary supplement products and dietary ingredients.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods (edible fruits and vegetables) and drug products.
Role of DSHEA
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labelling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and FDA regulations.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market
The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit
Dietary supplement manufacturers and distributors from making false claims (such as "natural" and "therapeutic," on supplement labels)
The law also prohibits the manufacture and sale of adulterated dietary supplements.
Aim of these act:
To make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabelled or adulterated products.
Act requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations.
Table of Contents
Short Title Reference Table Of Contents
Findings
Definitions
Safety of Dietary Supplements and Burden of Proof on FDA
Dietary Supplement Claims
Statements of Nutritional Support
Dietary supplement ingredient labeling and nutrition information labeling
New dietary ingredients
Good manufacturing practices
Conforming amendments
Withdrawal of the regulations and notice
Commission on dietary supplement labels
What is an RDA Europe Node and how to get involved. Webinar by RDA Europe 4.0 to introduce the network of RDA Europe nodes and the process to become a new node.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
DIETARY SUPPLEMENT
The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases.
Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take.
It is a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid.
A dietary substance use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
FDA Role
Companies can often introduce a dietary supplement to the market without notifying FDA.
FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace.
If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market.
FDA regulates both finished dietary supplement products and dietary ingredients.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods (edible fruits and vegetables) and drug products.
Role of DSHEA
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labelling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and FDA regulations.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market
The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit
Dietary supplement manufacturers and distributors from making false claims (such as "natural" and "therapeutic," on supplement labels)
The law also prohibits the manufacture and sale of adulterated dietary supplements.
Aim of these act:
To make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabelled or adulterated products.
Act requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations.
Table of Contents
Short Title Reference Table Of Contents
Findings
Definitions
Safety of Dietary Supplements and Burden of Proof on FDA
Dietary Supplement Claims
Statements of Nutritional Support
Dietary supplement ingredient labeling and nutrition information labeling
New dietary ingredients
Good manufacturing practices
Conforming amendments
Withdrawal of the regulations and notice
Commission on dietary supplement labels
What is an RDA Europe Node and how to get involved. Webinar by RDA Europe 4.0 to introduce the network of RDA Europe nodes and the process to become a new node.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
presentation about Nutraceutical
The term “nutraceutical” combines the word “nutrient” (a nourishing food or food component) with “pharmaceutical”(a medical drug). The word “nutraceutical” has been used to describe a broad list of products sold under the premise of being dietary supplements (i.e. a food), but for the expressed intent of treatment or prevent of disease.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
presentation about Nutraceutical
The term “nutraceutical” combines the word “nutrient” (a nourishing food or food component) with “pharmaceutical”(a medical drug). The word “nutraceutical” has been used to describe a broad list of products sold under the premise of being dietary supplements (i.e. a food), but for the expressed intent of treatment or prevent of disease.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
A nutraceutical is a food or a part of a food stuff that provides medical or health benefits, including the avoidance and handling of diseases. The food products which are used as nutraceutical are Probiotic, Prebiotic, Dietary fiber, Omega 3 fatty acid, and antioxidants. Nutraceuticals have received significant attention due to their speculative safety, potential nutritive and therapeutic effects. Nutraceuticals are alternative to modern medicines and also provide healthy living. To avoid side effects associated with medicines, live longer expectation and to increase the health value of our diet, nutraceuticals are being preferred. They possess abundant therapeutic benefits like anti-obesity, immune enhancement, natural antioxidant, cardiovascular effects, anti-diabetic, anti-inflammatory effects, etc. The main constituents of nutraceuticals are nutrients, herbals and dietary supplements which assist to maintain health, function against various diseases and ensure better quality of life. The aim of this article is to provide the current knowledge about the useful information about nutraceuticals. Parvaiz Ahmad Parry | Aadil Hussain Tantray | Aadil Mustafa | Shabir Ahmad Ganie | Mr Rajan Kothari"Nutraceuticals: New Concept of Medicines" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-4 , June 2018, URL: http://www.ijtsrd.com/papers/ijtsrd12970.pdf http://www.ijtsrd.com/other-scientific-research-area/other/12970/nutraceuticals-new-concept-of-medicines/parvaiz-ahmad-parry
NEUTRACEUTICAL CLASSIFICATION AND ITS GENERAL ROLE.pptxShohab Ahmed
Nutrition
It is the sum total of the processes involved in the taking in and the utilization of food substances by which growth, repair and maintenance of the body are accomplished. It involves ingestion, digestion, absorption and assimilation.
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable
bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic,
Honey, Amla, Ginseng, Ashwagandha, Spirulina
Herbal-Drug and Herb-Food Interactions: General introduction to interaction and
classification. Study of following drugs and their possible side effects and interactions:
Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.
The benefits and risks associated with functional foods and nutraceuticals are presented in the presentation. Also, way-forward is captured in light of the risks.
Nutraceutical is the hybrid of ‘nutrition’and ‘pharmaceutical’. Nutraceuticals; in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal natural foods. These nutraceuticals used in various diseases such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, hypertension etc. In whole, ‘nutraceutical’
has lead to the new era of medicine and health, in which the food industry has become a research oriented sector. This article aim to provide the knowledge of nutraceutical with its uses in various diseases.
Dr. sridhar rudravarapu invited speech- apitco pharmexcil -9 aug 2011Sridhar Rudravarapu
The presentation deliberated on the emerging market opportunities for the local pharma industries to focus on formulations for preventive health care & maintenance. Specific proposals were made for the Hyderabad pharma cluster to set up Nutraceutical/Health Product Incubation Center for serving the local MSME industry needs.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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A Comparative Study Of Regulatory Registration Procedure Of Nutraceuticals IN INDIA, CANADA AND AUSTRALIA
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 health‐related 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 it‟s 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.
PPC‟s 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 doesn‟t 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
http://indiankanoon.org/doc/986267/ 10-2-2013
http://www.researchandmarkets.com/reports/470869/strategic_analysis_of_the_australian
_and_new 10-10-2012
http://www.foodstandards.gov.au/foodstandards/foodsafetystandardsaustraliaonly/ 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 11-10-
2012
REFERENCES
A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA
42. http://laws-lois.justice.gc.ca/eng/acts/c-16.5/ 10-10-2012
http://www.fraclabs.org/index.php/newsevents/141-nutraceuticals-poised-for-a-
great-future 11-10-2012
http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/nutra-funct_foods-nutra-
fonct_aliment-eng.php#4 12-10-2012
http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php 12-10-2012
http://napra.ca/pages/Legislation/Food_Drugs_Act.aspx 12-10-2012
http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/index-eng.php 12-10-2012
A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA
43. • Mohamed Naeem Devala et al, Dietary Supplements: A Legal Status In India & In Foreign
Countries, Ijpps, Vol 3, Suppl 3, 2011
• Stauffer JE. Nutraceuticals. Cereals Food World. 1999; 44(2): 115-116.
• Allen L.V. Nutritional products, In: Covington T.R., Berardi R.R., Young L.L., Kendall
S.C., Hickey M.J., editors. (1997) Handbook of Nonprescription Drugs. Washington DC:
American Pharmaceutical Association.
• Thakur, N., Gupta, B. P., Nagariya, A. K., Jain, N. P., Banweer, J. and Jain, S.,
Nutraceutical: New Era‟s safe pharmaceuticals, J. Pharm. Res, 3: 1243-1247, (2010)
• Thakur, N., Gupta, B. P., Nagariya, A. K., Jain, N. P., Banweer, J. and Jain, S.,
Nutraceutical: New Era‟s safe pharmaceuticals, J. Pharm. Res, 3: 1243-1247, (2010)
• Hathcock J. Dietary supplements: How they are used and regulated. J. Nutrition. 2001;
131: 1114-1117.
A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA
44. • Allen LV. Nutritional Products, In: Covington TR, Berardi RR, Young LL, et
al. Editors. Handbook of Nonprescription Drugs. Washington DC: American
Pharmaceutical Association; 1997.
• Tyler VE, Foster F. Herbs and phytochemicals. In: Covington TR, Berardi
RR, Young LL et al. editors. Handbook of Nonprescription Drugs.
Washington DC: American Pharmaceutical Association; 1996
• www.nccam.nih.gov. National Institutes of Health National Center for
Complementary and Alternative Medicine.
• North Carolina Association for Biomedical Research,. Nutraceuticals, www.
bioscience. Org. July 2007
A COMPARATIVE STUDY OF
REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA