DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)characterization in the pharmacopoeia in official use (or in other officially recognizeddocuments) for tablets. Homeopathic medicines in tablet form are either prepared byimpregnation of preformed tablets or by compression of triturations with the vehicle. Themost commonly used liquid homeopathic medicines are either alcoholic solutions or oralliquids.Excipient: Substance needed for manufacturing a dosage form (used afterpotentisation) such as wheat starch and magnesium stearate for tablets. It may alsorepresent the substance of the dosage form.Homeopath: A qualified provider (practitioner) of homeopathic treatment.Homeopathic medicines: Any medicine prepared in accordance with a homeopathicmanufacturing procedure described by a pharmacopoeia in official use or other officiallyrecognized documents. A homeopathic medicine may contain a number of homeopathicpreparations.Homeopathy: Classical homeopathy is a system of medicine using preparations ofsubstances whose effects, when administered to healthy subjects, correspond to themanifestations of the disorder in the individual patients.Mother tincture (also called tincture): The initial homeopathic preparation made fromsource material that can be further potentised (also called “liquid stock”), sometimesused as homeopathic medicines, is regarded as the most concentrated form of afinished homeopathic medicine. Mother tinctures are obtained classically by macerationor percolation (sometimes also by digestion, infusion, decoction or fermentation)techniques from source materials according to a procedure prescribed by a recognizedhomeopathic pharmacopoeia. Sometimes a mother tincture corresponds to the firstdecimal dilution, “1D” or “1X” (10-1), mostly when dry plant material is used as startingmaterial.Nosodes: Homeopathic medicines prepared from disease products from humans oranimals; from pathogenic organisms or their metabolic products; or from decompositionproducts of animal organs.Potency: The denominated degree of serial trituration or dilution and succession that isreached for each homeopathic medicine. The degrees of dilution or potencies areNational Pharmaceutical Control BureauFirst Edition, January 201314
Drug Registration Guidance Document (<strong>DRGD</strong>)normally indicated by the letters D, DH or X for successive 1 to 10 (decimal) dilutions,the letters C, CH or K or CK for successive 1 to 100 (centesimal) dilutions while Q or LMdenote successive 1 to 50 000 (Hahnemannian quinquagintamillesimal) dilutions.Dilution by 1 to 10 denotes 1 part processed with 9 parts of diluent (Hahnemanniandecimal), dilution by 1 to 100, 1 part processed with 99 parts (Hahnemannian orKorsakovian centesimal), and so on. The number preceding the letters (e.g. D, C or LM)normally indicates the number of dilution steps employed (Table 1).As a consequence of different views in various approaches in homeotherapy andbecause the notion of these terms may depend on the nature of the starting materials,the terms “high potency” and “low potency” cannot be defined unambiguously.Potentisation (also called dinamization): The combined process of serial dilution andsuccussion or trituration at each step in the manufacture of homeopathic medicinesfrom stocks. (According to the tenet of homeopathy, potentisation represents theprocess by which the activity of a homeopathic medicine is developed.)Table 1: Potency tableDilution ratioCommondesignation(s)Examples1:10 a X 1X, 2X, 3X, etc.1:10 a D D1, D2, D3, etc.1:10 a DH DH1, DH2, DH3, etc.1:100 b C1C, 2C, 3C, etc.C1, C2, C3, etc.1:100 b CH1CH, 2CH, 3CH, etc.CH1, CH2, CH3, etc.1:100 b CK1:100 b K1CK, 2CK, 3CK, etc.CK1, CK2, CK3, etc.1K, 2K, 3K, etc.K1, K2, K3, etc.1:50 000 a LM 1LM, 2LM, 3LM, etc.1:50 000 a Q Q1, Q2, Q3, etc.National Pharmaceutical Control BureauFirst Edition, January 201315
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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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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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