DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)46. Sulphonamides Topical Use47. Sulphur All preparations Except External Preparation48. Squill Expectorant49. Terpene Hydrate ExpectorantCombinationsNot Allowed in the SpecifiedPreparation(s)1. Cough, Cold And AllergyProducts Containing:i) Antimony PotassiumTartrateii) Allylisothiocyanate/Mustard Oiliii) Turpentine OilExpectorantNasal Decongestant2. Vitamin(s) Eye DropsExpectorant/ AntitussiveNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 338
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 | 339
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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