DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)8.2 LIST OF PROHIBITED AND RESTRICTED EXCIPIENTS8.2.1 LIST OF PROHIBITEDEXCIPIENTS1. Colouring Agents(Including in Capsule Shells)8.2.2 LIST OF RESTRICTED EXCIPIENTSExcipients1. Colouring Agents(Including in Capsule Shells)Restrictionsa) Amaranth (CI= 16185, FD & CRed No. 2, E123)a) Tartrazine (CI=19140, FD & CYellow No.5,E102)Not allowed in thefollowing preparations:- Oral;- Rectal;- Vaginal or- Nasal Preparationsb) Red 2G Not allowed in thefollowing preparations:2. Sweeteners/ Flavouring Agent 2. Sweeteners/ Flavouring Agent- Oral Preparations; and- Preparations Used forMucosa Membranea) Cyclamates a) Menthol Limited to not more than10mg/dayb) Saccharin andSalts3. Others 3. PreservativesLimited to not more than5mg/kg/daya) Chlorofluorocarbons (CFC)b) Dibutyl Pthalatea) Chloroform Limited to not more than0.5% in Pharmaceuticalsfor Internal Useb) Thiomersal * Not allowed in ophthalmicPreparations* For other preparations, warning as specified in Appendix 9: LabellingRequirement, shall be included in the package insert and product literature ofproducts containing thiomersal.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 336
Drug Registration Guidance Document (<strong>DRGD</strong>)Additional Information1. Methylene Chloride/ Dichloromethane are not allowed as solvent in filmcoatingonly for locally manufactured products, in order to protect workersduring manufacturing process.2. Alcohol is not allowed unless it is essential to the formulation and no suitablealternatives to alcohol are available. Content of alcohol shall be at theminimum level as possible.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 337
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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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