DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1.3.4 ADDITIONAL GUIDANCE NOTES FOR FOOD PRODUCTSa) FoodsUnder Section 2, Food Act 1983:"Food" includes every article manufactured, sold or represented for use as food or drinkfor human consumption or which enters into or is used in the composition, preparation,preservation, of any food or drink and includes confectionery, chewing substances andany ingredient of such food, drink, confectionery or chewing substances.All food products must comply with the Food Act 1983 and Food Regulations 1985.b) List of Food Products that may contain Herbs or Botanical Plants under FoodRegulations 1985- Meat extract or meat essence- Botanical Beverage Mix (regulation 356)- Mixed Food Products- Food standards that contain words: “may contain other food”c) Permitted Added Nutrients in Food ProductsFor details, please refer to Food Regulations 1985, Table 1 under the Twelfth Schedule.d) Maximum Amounts of Vitamins and Minerals permitted in Food, as shown in Table Ibelow:Added NutrientVitamin AThiamineRiboflavinPyridoxineMaximum amount in recommended daily serving5,000 I.U.2.2 milligram3.2 milligram4 milligramsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 44
Drug Registration Guidance Document (DRGD)Added NutrientBiotinPantothenic acidNiacinAscorbic acidVitamin DVitamin ECalciumIodineIronPhosphorusFolic acidVitamin B 12Maximum amount in recommended daily serving400 micrograms14 milligrams22 milligrams100 milligrams800 I.U.50 I.U.1.4 grams200 micrograms20 milligrams1.4 grams400 micrograms4 microgramse) Permitted Bifido Bacteria in Food, as shown in Table II below:PERMITTED BIFIDO BACTERIA IN FOODNameMinimum viable cells/gBifido bacterium lactis (L-form) 10 6Bifido bacterium longum (L-form) 10 6National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 45
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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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