DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)ATC CodeD05A Antipsoriatics for topical useRecommended Pack sizesLiquid – max 500ml (with a dispenser).Others – max *500gBar – max 100g* Notes:• Tar Preparations• Coal Tar Ointment/ Solution• Liquor Picis Carbonis (LPC) 500g• Dithranol Ointment 500g• Cocois Co Lotion 500mlD06A Antibiotics for topical use Max 20gExcept D06BB Antivirals - Max 10gD06B A 01 Silver Sulphadiazine formanagement of burns - 500gD07ACorticosteroids, plainD07AA Corticosteroids, weak (group I)D07AB Corticosteroids, moderatelypotent (group II)D07AC Corticosteroids, potent(group III)D07AD Corticosteroids, very potent(group IV)D07AA – Max 100g to **500gD07AB – Max 50g to **500gD07AC – Max 15gD07AD – Max 15g** Note:Pack size of 500g is allowed for hospitalsand skin specialist clinics.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 424
Drug Registration Guidance Document (DRGD)ATC CodeRecommended Pack sizesD07C Corticosteroids,combinations with antibioticsD07CA Corticosteroids, weak,combinations with antibioticsD07CB Corticosteroids, moderatelypotent, combinations withantibioticsD07CC Corticosteroids, potent,combinations with antibioticsD07CD Corticosteroids, very potent,combinations with antibioticsD07CA - Max 100gD07CB - Max 50gD07CC - Max 15gD07CD - Max 15gD08A Antiseptics anddisinfectantsLiquid antiseptics/ disinfectants - 1LitreOthers - max 60gD10A Anti-acne preparations fortopical useExcept for D10AA Corticosteroids,combinations for treatment of acneD11AF Wart and anti-cornpreparationsLiquid preparation - max 250ml(recommended to be used with adispenser)Bar - max 100gAll others - max 60gMax 15mlM02A Topical products for jointand muscular painD11AX11 HyperpigmentationLiquid – 250mlOthers, Max – 60gMax 60gReference: Circulars(bil 16) dlm bpfk02/5/1.3.pdfBil (22) dlm BPFK/02/5/1.3.pdfBil (21) dlm.BPFK/02/5/1.3.pdfBil (24) dlm BPFK/02/5/1.3.pdf(1) dlm. BPFK/02/5/1.4Bil (4) dlm BPFK/PPP/01/03 Jld 1National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 425
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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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