DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)4.2 NEGATIVE LISTHomeopathic products containing single or multiple ingredients inAttachment 2 and Attachment 4 will not be registered by the Authority.4.3 LIMIT OF HOMEOPATHIC INGREDIENTS IN MULTI INGREDIENTHOMEOPATHIC PRODUCTSHomeopathic Products are allowed to contain a maximum of 12 potentisedsingle homeopathic dilutions.5. QUALITYA certificate of analysis (CoA) for raw material potentised dilution and finishedproduct must be provided as proof on the dilution used.6. GOOD MANUFACTURING PRACTICEThe requirements for Good Manufacturing Practice of the premises as outlined in theGuidelines on Good Manufacturing Practice (GMP) for Traditional Medicines apply toall homeopathic products.7. LABELLINGThe labelling of homeopathic products is the same as for traditional products inDRGD with the following additional requirements:On the label of this homeopathic product:a) The word „homeopathic product‟, „homeopathic medicine‟, „homeopathicpreparation‟, „homeopathic remedy‟ (either one) - must appear on the innermostlabel of the container.b) The scientific name or common name of the active ingredient.c) Potency and type of scale use.d) Declare the percentage of alcohol contained in the product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 304
Drug Registration Guidance Document (DRGD)8. INDICATIONS FOR USEIndications allowed for homeopathic product is the same as those allowed fortraditional products in the DRGD.Recommended use or indications for specific claims must be supported by evidencefor the multi ingredient homeopathic products.No indication will be allowed for single homeopathic potentised dilution in the form ofraw material and finished homeopathic product. No indications are also allowed formother tinctures.ATTACHMENTSAttachment 1:List of “Single Homeopathic Potentised Dilution (2C or 4X or 1:10000)”exempted from the Poisons List.No. Ingredient1. Aconite2. Amyl nitrite3. Antimony4. Apomorphine5. Arsenic6. Barium7. Belladonna8. Bismuth9. Boric Acid10. Caffeine11. Cantharidin12. Colchinine13. Coniine14. Creosote15. Curare16. DigitalisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 305
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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