DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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