NUTRACEUTICALS / NATURAL PRODUCT

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1 NUTRACEUTICALS / NATURAL PRODUCT: HOW TO BRING THEM TO HIGHER BIO-BORNEO-2015 Dr. RAVI K. B B.V.Sc & AH., M.V.Sc (ARGO). COO and Test Facility Management MyBioscience Lab Sdn. Bhd., Melaka, Malaysia.

2 INTRODUCTION Dr. RAVI K. B. B.V.Sc & AH., M.V.Sc (ARGO)., University of Agriculture Sciences (UAS - Bangalore) Karnataka Veterinary, Animal and Fisheries Sciences University COO and Test Facility Management MyBioScienceLab Sdn. Bhd., Ayer Keroh, Melaka., Malaysia. Experience: TEAM LEADER TOXICOLOGY Bioneeds India Pvt., Ltd., RESEARCH SCIENTIST Advinus Therapeutics Pvt. Ltd RESEARCH ASSOCIATE Project Directorate Animal Disease Monitoring and Surveillance (PD_ADMAS). Govt. of India.

3 NUTRA V/S PHARMA PHARMACEUTICAL Drug Used in the Treatment of disease NUTRACEUTICAL Nutrient that may prevent the Disease

4 CONCEPT OF NUTRACEUTICALS Nutraceutical : Food with Therapeutic Importance

5 NUTRACEUTICALS PLAY BETWEEN FOOD AND DRUG Food Target Group Examples Functional Foods and Nutritional Supplements Healthy people seeking to preserve wellness Probiotic Yogurts Weight loss bars Vitamin and mineral Supplements NUTRACEUTICALS Core Nutraceuticals People with common health Problems Cholesterol lowering products Products to Slow progression of Diabetes, Dementia and age related muscular dystrophy Medical Nutrition Patients with Special nutritional needs Specialized infant feeding formulas. Nutrition solution for fail or Chronically ill. Other Clinical nutrition products Drug Channels Supermarkets Online Supermarkets Pharmacies Online Pharmacies (Often with Medical Prescription)

6 RANGE OF NUTRACEUTICALS

7 GLOBAL TREND ON NUTRACEUTICALS

8 GLOBAL TREND Focused on safety and labeling with lesser emphasis (as compared to pharmaceuticals) Consumers are largely responsible. Good Manufacturing Practice (GMP) Increased regulation - benefit the industry Hence; GMP regulations are driving the industry.

9 MARKET DYNAMICS Global market reached $142.1 billion in Expected to reach $204.8 billion by 2017 (Anticipated CAGR of 6.4%) The U.S. offers the most active market, but developing countries show signs of rapid growth. Increased safety, regulation, and compliance requirements are increasing costs globally. Industry consolidation is expected to continue to drive

10 OBJECTIVE BEHIND DEVELOPMENT OF NUTRACEUTICALS

11 OBJECTIVE

12 DEVELOPMENT PROCESS CONCEPT DEVELOPMENT Brainstorm Focus Group Protocepts CONCEPT DEVELOPMENT Ingredients Formulations Process Prototype COMERCIALIZATION Scale Up Shelf Life Nutritional Stability Consumer acceptability QUALITY ASSURANCE SAFETY QUALITY COMPLIENCE PERFORMANCE

13 TYPES OF CLAIMS Types of claims are: General or Nutritional Claims; Functional Claims (Medium); Disease Risk Reduction Claims (High).

14 STEP TOWARDS HIGHER CLAIM EFFICACY POTENCY QUALITY SAFETY REGULATORY REQUIREMENTS

15 EFFICACY Key Step Towards Higher Claim A product without efficacy is no use Reliability of efficacy Growth promotion Wellness Memory Enhancement Hair growth formulae Antidiabetic Anti-cancer etc.,

16 POTENCY Yet another Key Step towards the Higher Claim POTENCY: Ability of an Active to elicit desired Pharmacological response 100% EFFICACY = POTENCY

17 PRE- CLINICAL SAFETY Lethal dose LD50 Genetic Toxicity Safety Pharmacology - Respiratory, Cardiac and CNS system Repeated dose Toxicity Sub- acute to Sub-Chronic Chronic Toxicity 6-12 Months Developmental and reproductive toxicity (DART) Carcinogenicity

18 CLINICAL SAFETY

19 PHASE & DURATION

20 QUALITY Most important requirement Both at Manufacturing and at Testing stages All the manufacturing as per GMP All the testing Pre-Clinical - as per GLP All the testing Clinical - as per GCP GMP - GLP - GCP

Federation Russia In Total : 194 Authorities Globally http://www.

21 REGULATORY REQUIREMENTS Intended regulatory submission requirements USFDA EU NPCB-Malaysia CDSCO/DCGI India Russian Federation Russia In Total : 194 Authorities Globally

22 LABEL CLAIMS Reference: National Pharmaceutical Control Bureau (NPCB)/ICH/USFDA/FSSA

23 Non-Permissible Product Name Prohibited use of DISEASE NAMES as stated in the Medicines (Advertisement and Sale Act 1956 (revised 1983) Diabetes, Asthma, Cancer

24 Single active as a product name Prohibited use of a single active ingredient as a product name in products containing more than one active ingredient unless product name contains words such as Plus, Compound, Complex, Herbanika If the product contain Vitamin C, Vitamin E and Fish Oil. Product name: Vitamin C is not allowed but product name: Vitamin C Plus is allowed.

25 Use of superlative names Prohibited use of superlative Names which indicates superiority inefficacy Power, Superior, Pure, Mustajab, Safe, Healthy, Penawar, VIP, Good, World Number 1

26 SPELLING OF WORDS - CONFUSION Prohibited use of spelling of words which may cause confusion 1. Words which involve names of/part thereof: 20 disease names prohibited in the Medicines (Advertisement and Sale) Act 1956 (Revised 1983) 2. Other diseases without scientific proof 3. Prohibited indication Go Out = GOUT (label) Utix

27 AMBIGUOUS PRODUCT NAME Prohibited use of names which may cause ambiguity Ambiguous product name B For Energy?

28 OFFENSIVE OR INDECENT NAMES Prohibited use of names which may be offensive or indecent SENXBIG=SEnXBIG(label) Sexy, Enjoy, Paradise, Heavenly, Blue boy, Casanova, Desire

29 NON- CONGRUENT NAMES Product name which is not congruent with the active ingredient. The active ingredient is Evening Primrose oil (EPO) and the product name: Marine tablet is not allowed.

30 PROHIBITED PRODUCT NAMES Prohibited use of product names which has elements of ludicrous belief Statements referring to ancient believe/negative spirits/supernatural power Words such as miracle, magic, magical, miraculous, saintly, heavenly

31 PRODUCT NAME SIMILAR TO THE SPELLING Prohibited use of product names similar to the existing approved product names Product name similar to the spelling and pronunciation of words of an existing product names Elegen vs L-gen vs L-jen Forte vs Fort

32 PRODUCT NAME SIMILAR TO A FOOD / BEVERAGE Prohibited use of product names which may cause ambiguity in the nature of product (drug/ food/ beverage). Product name similar to a food/ beverage name Juice, Health drink, Beverage, Kooky

33 NAMES REPRESENTS PROFESSIONAL ADVICE Prohibited use of product names which represents professional advice or opinion Dr Sunny, Professor

34 NAME - SYMBOLIZE A CLAIM Product name that symbolize a claim Vigour, Youthful, High, Hi

35 PRODUCT NAME - >1 FORMULATION Product name that uses strength but formulation contains more than one active ingredient. If the product contains multivitamins and minerals. Product name: XXX multivitamins and minerals 500mg is not allowed.

36 OTHER PROHIBITED PRODUCT NAMES Other prohibited product names Minda, IQ, Smart, Unique, Ultra Mega, Detox

37 NAMES OF ORGANS Names of organs should not be used Heart, kidney, skin, liver

38 AMENDMENT IN CHANGE OF CLAIMS

39 AMENDMENT TO CLAIMS Change to its recommended dose. Change to its recommended duration of use. The deletion or modification of risk information. Change of its recommended use or purpose. Change of the source material. Changing any of its medicinal ingredients

40 AMENDMENT TO CLAIMS Change to the potency of any of its medicinal ingredients. Cont.. Change affecting its safety or efficacy not arise as a result of Change to the quantity of a medicinal ingredient. Addition or substitution of a medicinal ingredient Change to its dosage form. Change to its recommended route of administration. One or more of the changes to its specifications. Removal of a test method set out in the specifications,

41 CONCLUSION Nutraceuticals are playing an important role Control of purity, efficacy and safety. Product wants to enter in the Nutraceutical market of particular country, Regulatory framework of that country The business is run smoothly. Country-specific health & label claims and advertising.

42 Namasthe -The Devine in me honors the divine in you

REGULATORY REQUIREMENTS FOR REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA

REGULATORY REQUIREMENTS FOR REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA TAN JAS MIN National Pharmaceutical Regulatory Agency Ministry of Health Malaysia Email address: tanjasmin@npra.gov.my ORGANISATION