DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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1. GENERAL INFORMATIONSDrug Registration Guidance Document (DRGD)1.1 DEFINITIONS1.1.1 Traditional medicineAs defined under the CDCR 1984, traditional medicine refers to any productused in the practice of indigenous medicine, in which the drug consist solelyof one or more naturally occurring substances of a plant, animal or mineral, ofparts thereof, in the unextracted or crude extract form, and a homeopathicmedicine. It shall not include any sterile preparation, vaccines, any substancederived human parts, any isolated and characterized chemical substances.1.1.2 Finished Herbal ProductFinished herbal products consist of herbal preparations made from one ormore herbs. If more than one herb is used, the term “mixture herbal product”can also be used. Finished herbal products and mixture herbal products maycontain excipients in addition to the active ingredients. However, finishedproducts or mixture herbal products to which chemically defined activesubstance have been added, including synthetic compounds and/ isolatedconstituents from herbal materials, are not considered to be herbal.1.1.3 Herbal RemedyAny drug consisting of a substance or a mixture of substances produced bydrying, crushing or comminuting, but without subjecting to any other process,a natural substance or substances of plant, animal or mineral origin, or anypart of such substance or substances.1.1.4 Homeopathic MedicineAny pharmaceutical dosage form used in the homeopathic therapeutic systemin which diseases are treated by the use of minute amounts as of suchsubstances which are capable of producing in healthy persons symptomssimilar to those of the disease being treated.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 238
1.2 EXEMPTION FROM PRODUCT REGISTRATIONDrug Registration Guidance Document (DRGD)The following preparations do not require registration with the Authority:a) Extemporaneous preparation that has been prepared and given directly to thepatient by any traditional practitioner during the course of treatment;b) Traditional preparation containing plants, animal parts or mineral substanceor a mixture of these substances of natural origin that is produced onlythrough drying, without any treatment/process involved. For example, rawherbs;c) Traditional preparation containing plants, animal parts, mineral substance/extracts or a mixture of these substances of natural origin traditionally usedas food, spices or flavouring of food which do not have any medicinal claim;d) Traditional preparation that is used for cosmetic purposes such as to whitenor improve the appearance of skin, hair, teeth, etc has to be registered ascosmetic product.1.3 PREPARATIONS WHICH ARE NOT ALLOWED TO BE REGISTEREDa) Traditional preparation with the indication as listed in “List of Non PermissibleIndications for Natural Product”(Reference: Medicine Advertisement and Sale Act 1956)b) Traditional preparation containing herbal ingredients as listed under PoisonAct 1952 except for those exempted for homeopathic preparation.Please refer to Section 4 - General guidelines for the registration ofhomeopathic products.c) Traditional preparation containing ingredient known or reported to cause anyadverse effect on humans. Please refer to List of Botanicals (& botanicalingredients) which are banned due to reported adverse event.d) Traditional preparation containing combination of plants, animal parts ormineral substance of natural origin with chemical/ synthetic substance withtherapeutic effect.e) Traditional preparation containing combination of plants, animal parts ormineral substance of natural origin with vitamins and amino acids.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 239
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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