DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)TABLE 2:DERMATOLOGICALS PREPARATION MAXIMUM PACK SIZERECOMMENDATIONS FOR PHARMACEUTICAL PRODUCTSATC CodeRecommended Pack sizesD01A Antifungals for topical use Liquid preparation - max 250mlOthers - max 60gD02A Emollients and protectives Non poisons (liquid preparation) - 250mlOthers - 60g (max 500g for emollients)Except D02AC Soft paraffin and fatproducts andD02AX Other emollients and protectives(Aq. Cream) - max 500gD03Preparations for treatment ofwounds and ulcersMax 500ml to 1LNotes:• Chlorhexidine gluconate aqueous 1L• Povidon 10% 500ml• Povidon-iodine 1L• Dermacyn 500ml• Hydrogen peroxide 1L• Prontosan 500ml• Octenisan 500ml• Acetic acid 500ml• Cetrimide 500mlD04A Antipruritics, anesthetics,etc.Except D04AA Antihistamines fortopical use (not allowed forregistration)Liquid – max 250mlOthers – 60gNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 432
Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 433
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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