DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Dosage Form Description1. Tablet2. Capsule3. LiquidShape, size, colour, odour, taste, marking, emboss, type oftablet (e.g. coated, uncoated, film, sugar etc.)Shape, size, colour, odour, taste, marking, emboss, coating,content of capsule, type of capsule (e.g.: soft, hard, chewableetc.)Clarity, type (e.g. solution/ suspension/ emulsion etc.), taste,odour, colour.4. Powder Colour, odour, taste etc.5. Pill Colour, odour, taste, size etc.6. Granules Colour, odour, taste, size etc.Indication/ UsageState briefly recommended use(s) of product. The following indications are allowed:‣ Used as a Health Supplement; or‣ Vitamins and mineral supplements for pregnant and lactating women.Recommended Dose (Dose/ Use Instruction) & Route of administrationState the dose (normal dose, dose range) and dosage schedule (frequency, duration ifapplicable). Dosage for adults and children (where appropriate) shall be stated.ContraindicationState conditions for which or under which the product shall not be used.Note 1:Indicate clearly which conditions are:- absolutely contraindicated,- contraindicated but may be used under special circumstances and whatprecautions to be taken in such cases.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 192
Drug Registration Guidance Document (<strong>DRGD</strong>)Warnings and PrecautionsState briefly precautions and warnings necessary to ensure safe use of the product e.g.caution against giving to children and elderly; use in pregnancy and lactation; in infants;etc.Drug InteractionsState only interactions which are observed and/or for which there is potential clinicalsignificance. Interactions may occur with- other medicinal products used;- other herbs/ substance;- meals, or specific types of food.Side Effects/ Adverse ReactionsState in order of severity and frequency, the side effects, adverse reactions, toxiceffects, etc. (i.e. reactions, toxic effects, other than those desired therapeutically)including reactions such as allergy, hypersensitivity, dependence, addiction,carcinogenicity, tolerance, liver/ kidney toxicity etc.Indicate also symptoms and sites of effects/reactions.Note 1: Reactions, whether minor or serious, shall be stated.Note 2 : Severity, reversible, frequency of occurrence shall be indicated whereverpossible.Note 3 :Clinical tests for detection of „sensitive‟ patients, measure for management ofadverse reactions developed shall be described wherever possible.Pregnancy and LactationPlease state any effect on pregnancy and lactation if applicable.Signs and Symptoms of Overdose and TreatmentState briefly symptoms of overdose/ poisoning, and where possible, recommendedtreatment and antidotes for overdose/ poisoning.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 193
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Page 142 and 143: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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