A Comparative Study Of Regulatory Registration Procedure Of Nutraceuticals IN INDIA, CANADA AND AUSTRALIA

3,354 views
3,221 views

Published on

Its all about A brief Comparative study of Nutraceuticals in India, Canada & Australia.

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
3,354
On SlideShare
0
From Embeds
0
Number of Embeds
3
Actions
Shares
0
Downloads
185
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

A Comparative Study Of Regulatory Registration Procedure Of Nutraceuticals IN INDIA, CANADA AND AUSTRALIA

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

×