DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)b) Locally-acting lozenges/ pastilles;c) Topical analgesic/ counter-irritants;d) Topical nasal decongestants;e) Emollient/ demulcent/ skin protectants;f) Keratolytics;g) Anti-dandruff;h) Oral care;i) Anti-acne;j) Medicated plasters/ patch/ pad; andk) Topical antibacterial.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 128
Drug Registration Guidance Document (<strong>DRGD</strong>)2.1.1 GENERAL REQUIREMENTS FOR FULL EVALUATIONNo.1.Step I: Product ValidationIs your product has a brand name? (Yes/ No)(If yes, please provide brand name and product name)2. Dosage Form3.4.5.Active Ingredient(s)a) Active Ingredient Nameb) Strength of Active Ingredient (Quantity unit/ dose)c) Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine orOthers/ Plant/ Others)d) Form of Active Ingrediente) Remarks (if any)Excipient(s)a) Excipient nameb) Strength of Excipient (Quantity unit/ dose)c) Function of excipient (e.g. absorbent, diluents, bulking agent, coatingagent, anti-caking agent etc.)d) Source of excipiente) Remarks (if any)Is there any source of ingredients derived from animal origin, including activeingredient? (Yes/ No)6. Manufacturer (Name and Address)7. Is the selected manufacturer a contract manufacturer? (Yes/ No)8.9.Is the product from second source? (Yes/ No)If yes, please provide:a) Letter of declaration stating that this product is a second source productb) Registration number and product name of the first sourceIs this product containing any premix? (Yes/ No)a) State your premix formb) Manufacturer namec) Manufacturer addressd) Certificate of Good Manufacturing Practice (GMP)e) Formulationf) Manufacturing Processg) Specification of Analysish) Certificate of Analysis (CoA)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 129
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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