DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)TABLE 1:Oral Liquid Preparation Maximum Pack Size Recommendations forPharmaceutical ProductsR05R05AR05CR05DATC CodeCough & cold preparationCold preparationAntitussivesExpectorantsRecommended Pack sizesMax 120ml(except for Pholcodine – Max 90ml)R06A Antihistamines systemicR03Anti-asthma & COPD productsR03A Beta2 stimulantsR03B Xanthines (theophyllines)R03C Non-steroidal respiratory anti-inflammatory (ketotifen)Max 120ml(except for Hydroxyzine HCl Syrup- 200ml )Max 120mlN02B Non-narcotic analgesics Max 120mlM01A Antirheumatics non-steroid Max 120mlH02H02ASystemic corticosteroidsPlain corticosteroids(except for Procaterol - 250ml)Max 120mlM06A Anti-inflammatory enzymes Max 500mlA02AA02BAntacid antiflatulentsAntiulcerantsMax 250mlA06A Laxatives Max 120mlA03A03AA03EA03FA07Functional GI disorder drugsAntispasmodicOther GI combinations (Colimix)Gastroprokinetics(Metoclopramide, Motilium)Antidiarrhoea(except for Lactulose - 500ml)Max 120mlNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 430
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 | 431
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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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