DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)ATC CodeA04A Antiemetic + AntinauseantsN07C Antivertigo productsN03A AntiepilepticsRecommended Pack sizesMax 120mlMax 250ml(Except for Sodium ValproateSyrup - 300ml)N06A Antidepressant & MoodstabilizerMax 250mlN06D Anti DementiaN07D Anti-Alzheimer productsN05A AntipsychoticsP01B AntihelminticsN05C Tranquillizers/ AnxiolyticsA05B Hepatic protector – lipotropicsJ05 Antivirals for systemic useJ05B Antivirals excluding Anti-HIVJ05C HIV antiviralsJ01 Antibiotics systemicJ01A Tetracyclines & combinationJ01B Chloramphenicols + combinationsJ01C1 Oral broad spectrum PenicillinsJ01D1 Oral CephalosporinsJ01E Trimethoprim combinationsJ01F Macrolides & similar typeJ01H Medium & narrow spectrumpenicillinsJ01X Other antibioticsJ02A Systemic Antifungals AgentsN06D NootropicsN06E Neurotonics & MiscellaneousG01A1 TrichomonacidesMax 20ml for dropsMax 60mlMax 250mlMax150mlMax 250mlMax 120mlMax 125 mlMax 120mlNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 422
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 | 423
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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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