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
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)

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

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.

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‟.

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

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)

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.

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

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.

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

OBJECTIVE
 A Comparative study of Regulatory Registration Procedure of
Nutraceuticals in India, Canada, Australia

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

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.

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.

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.

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.

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.

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.

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.

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 .

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.

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

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

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.

 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.

 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 .

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

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.

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.

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.

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)

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

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

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 .

 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

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.

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)

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.

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.

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

 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

 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

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