DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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