DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)8. Recommended Dose OR Dose/ Use InstructionRecommended Dose (for full evaluation only):Please state the dose (normal dose, dose range) and dosage schedule(frequency, duration); and route of administration appropriate for eachtherapeutic indication.Dosage for adults, and, children (where appropriate) shall be stated.Dosage adjustments for special conditions, e.g. renal, hepatic, cardiac,nutritional insufficiencies (where relevant) shall be stated.Where appropriate, diluents and instructions for dilution, reconstitution anduse or administration of the product shall be clearly stated.Distinction shall be made between therapeutic and prophylactic doses,and between dosages for different clinical uses, where applicable.Ensure that dosage recommendation is relevant and appropriate for theproduct.Dose/ Use Instruction (for abridged evaluation only):State the dose (normal dose, dose range) and dosage schedule(frequency, duration) [and route of administration appropriate for eachtherapeutic indication]. Dosage for adults, and where appropriate children,should be stated.Dosage adjustments for special conditions e.g. renal, hepatic, cardiac,nutritional insufficiencies, where relevant, shall be stated.9. Route of Administration (for full evaluation only)Details are as for Recommended Dose stated above.Please select route of administration from the drop-down list, e.g.intramuscular, oral, rectal, sublingual, etc.10. ContraindicationPlease state conditions for which or under which the product shall not beused.Indicate clearly which conditions are :National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 442
Drug Registration Guidance Document (<strong>DRGD</strong>)- absolutely contraindicated;- contraindicated but may be used under special circumstances andwhat precautions to be taken in such cases.Where there is likelihood that additives are added, especially forintravenous solutions, foreseeable contraindicated additives shall bementioned (where applicable).Concurrent drug therapy which are contraindicated shall also be includedwhere possible (where applicable).11. Warnings and PrecautionsPlease state briefly on warnings and precautions, where necessary toensure safe use; and efficacious (where applicable) of the product;(e.g. caution against giving to children and elderly; against driving motorvehicles or manning heavy machinery after intake of product; use inpregnancy and lactation; in infants; etc.)12. Interactions With Other MedicamentsPlease state interactions which are observed and/or for which there ispotential clinical significance.Interactions may occur with:- medicinal products used for the same indication;- medicinal products used for other indications;- meals, or specific types of food.13. Pregnancy and LactationUse in Pregnancy:The following shall be stated:a) conclusions from the animal reproduction/ fertility study and the humanexperience;b) the risk in humans at different stages of pregnancy, as assessed froma);c) information on the possibility of using the medical product in fertile andpregnant women.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 443
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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