DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)10.7 OTHER CONSIDERATIONS FOR IMPLEMENTATIONVARIATION APPLICATIONSChange in patient pack size with or without involving new pack type shallbe submitted to Variation Section, Centre for Post Product Registration.Supporting documents required are:a. Justification for the new pack size and/or type;b. Accelerated stability data (3 or 6 months) and stability report for newpack types; andc. Commitment to provide complete real time stability data and reportwhen available.List of products with recommended pack sizes for oral liquid preparationsand dermatological are as in Table 1 and Table 2 respectively.For tablets and capsules in loose pack, the maximum packing size willdepend on the highest dosage and frequency per patient‟s treatment orone month supply.10.8 IMPLEMENTATION TIMELINEImplementation of patient dispensing pack has been conducted in aphased manner to ensure smooth transition while ensuring no supplydisruption to patients. This implementation is effective since 1 March2008 on a voluntary basis and mandated on 1 September 2008.All products manufactured from 1 September 2008 regardless whether itis imported or locally manufactured will need to conform to the principlesof this guide.10.9 CONCLUSIONPatient Dispensing Pack is convenient, safe and improves quality ofdispensed medicines. It will increase efficiency in dispensing and improvesafety by reducing the risk and possibility of error. It will also result in areduction in drug waste and better use of resources.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 426
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 | 427
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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