DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)- Suppositories and vaginal tablets;- Transdermal patch;- Sublingual preparations;- Preparation in combination with non-homeopathic active ingredient, such asvitamins, minerals and herbs.- Preparations containing substance listed in the Poison List (except Attachment 1).4. INGREDIENTSHomeopathic products are prepared from natural or synthetic sources that arereferenced in pharmacopoeia monographs or other recognized documents. Notconsidering imponderable, the source materials for homeopathic medicines mayconsist of the following:- Plant material such as: roots, stems, leaves, flowers, bark, pollen, lichen, moss,ferns and algae;- Microorganisms such as: fungi, and plant parasites;- Animal materials such as: whole animals, animal organs, tissues, secretions;- Minerals and chemicals.For each medicinal ingredient, a copy of the monograph from the pharmacopoeia towhich the applicant attests must be provided. Also for homeopathic medicines with aspecific claim, it must be supported by the same level of evidence as for traditionalproducts.Products containing a combination of homeopathic and non-homeopathic medicinalingredient will not be evaluated as a homeopathic product.4.1 POSITIVE LISTHomeopathic medicinal ingredients are allowed as multi ingredient inhomeopathic products and the active ingredient must be documented in amonograph as a homeopathic medicinal ingredient as stated in the currentedition of Homeopathic Pharmacopoeias recognized by the Authority listed inAttachment 3.Homeopathic products are allowed to be registered when the homeopathicmedicinal ingredients used in their products are more than 2C or 4X.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 306
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 | 307
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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