DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO. VITAMINS & MINERALS UPPER DAILY LIMIT22. Manganese 3.5 mg23. Molybdenum 0.36 mg24. Phosphorus 800 mg25. Selenium 0.2 mg26. Zinc 15 mgNote:1. Vitamin K (K1 and K2) is restricted only for combination with other vitamins andminerals in oral preparations. Vitamin K (K1 and K2) as a single ingredient in anoral preparation is not allowed.2. For pre and antenatal use, as part of a multivitamin and mineral preparation,levels higher than the 20mg limit established for adults may be permitted at thediscretion of the Authority.3. Any form of fluoride as an ingredient is not permitted in formulation of healthsupplement products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 180
Drug Registration Guidance Document (<strong>DRGD</strong>)4.4 HEALTH SUPPLEMENT CLAIM4.4.1 CONDITIONSAll claims made for HS shall:i) be consistent with the definition of HS;ii) enable consumers to make an informed choice regarding products;iii) not be misleading or false;iv) support the safe, beneficial and appropriate use of the product;v) maintain the level of scientific evidence which is proportional to the type ofclaims;vi) be for health maintenance and promotion purpose only;vii) not be medicinal or therapeutic in nature, such as implied for treatment, cure orprevention of disease.4.4.2 TYPES AND EVIDENCE OF CLAIMSi) A health supplement claim refers to the beneficial effects of consuming HS topromote good health and well-being (physical and mental) by providing nutrition,enhancing body structure/ function, relieving physiological discomfort and/orreducing the risk of health related conditions or diseases.ii) Types of HS claims are:o General or Nutritional Claims;o Functional Claims (medium);o Disease Risk Reduction Claims (high).iii) For a HS product making a General or Functional Claim on vitamin(s) and/ormineral(s), it must contain minimum of 15% of the Codex Nutrient Reference Value(NRV) per daily dose of the vitamin(s) and/or mineral(s). Other ingredients must besubstantiated by the evidences to which it has been supported.For example, if vitamin is less than 15% NRV, then the specific claim for this vitaminis not allowed unless there is evidence to support effect below this value.iv) For a HS product making Disease Risk Reduction Claim, it must be substantiated bythe evidences to which it has been supported.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 181
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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