DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)8.3.2 List of Restricted Colouring AgentsThe following colouring agents are ALLOWED in preparations as stated in theparentheses:NO.1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.COLOURING AGENTSDihydroxyacetone(external use with specific drugs only)Bismuth Oxychloride(external use only, including eye)Ferric Ammonium Ferrocyanide(external use only, including eye)Ferric Ferrocyanide(external eye only)Chromium Hydroxide Green(external use only)Chromium Oxide Green(external use only, including eye)Guanine(external use only)Prophyllite(external use only)Mica(external use only, including eye)Bronze(external use only, including eye)Copper(external use only, including eye)Zinc Oxide(external use only, including eye)Quinizarine Green SS/ D & C Green No. 6(external use only)Pyranine Concentrated/ D & C Green No. 8(external use only)Orange II/ D & C Orange No. 4(external use only)COLOURINDEXNUMBER (CI)7716377289751707701977947615655904015510National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 344
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.16.17.18.19.20.21.22.23.24.25.26.27.28.COLOURING AGENTSDibromofluorescein/ D & C Orange No. 5(mouth wash, dentifrices, external use only)Diiodofluorescein/ D & C Orange No. 10(external use only)D & C Orange No. 11(external use only)Ponceau SX/ FD & C Red No. 4(external use only)Lithol Rubin B/ D & C Red No. 6(may be use in combination; total not more than 5mg/day)Lithol Rubin B CA/ D & C Red No. 7(may be used in combination; total not more than 5mg/day)D & C Red No. 31(external use only)Deep Maroon/ D & C Red No. 34(external use only)D & C Red No. 39(external use only, not more than 0.1%)Uranine Acid Form/ D & C Yellow No. 7(external use only)EXT. D & C Yellow No. 7(external use only)Uranine Sodium Salt/ D & C Yellow No. 8(external use only)Tartrazine/ FD & C Yellow No. 5/MA Yellow A-2/ Aluminic Lake(external use only)COLOURINDEXNUMBER (CI)4537045425147001585015850:115880:145350:14535019140National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 345
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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