DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2. General Requirements for Registration of Natural Products2.1 Ingredients2.1.1 Active Ingredients2.1.2 Premix2.1.3 Prohibited/ Banned Ingredients2.1.4 Use of Protected/ Endangered Ingredients2.2 Excipients2.3 Indications2.3.1 Indications Acceptable for Natural Products2.3.2 Non-Permissible Indications2.4 Product Name2.5 Quality Control2.5.1 Sample for Testing2.5.2 Appeal for Sample Retesting2.5.3 Quality Testing for Specific Ingredient2.5.4 Limit Test for Heavy Metals2.5.5 Disintegration Test2.5.6 Test for Uniformity of Weight (For Tablets and Capsules Only)2.5.7 Tests for Microbial Contamination2.6 Stability Data2.7 Labelling Requirement2.7.1 Statements to be stated on Product Label2.7.2 Specific Labelling Statements/ Warning & Precautions2.7.3 Cautionary Statement for Products Specially Used in Women2.7.4 Prohibited Visual/ Graphics/ Statement on Label of Natural Products inWomen3. Product Specific Requirements:3.1 Foot Patch3.2 Herbal Tea3.3 Homeopathic ProductsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 240
1. GENERAL INFORMATIONSDrug Registration Guidance Document (<strong>DRGD</strong>)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 | 241
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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