DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 8:LIST OF PERMITTED, PROHIBITED AND RESTRICTEDSUBSTANCESIMPORTANT NOTES:The following lists are by no means exhaustive.Outline:8.1 List of Prohibited and Restricted Active Ingredients and Combination8.1.1 List of Prohibited Active Ingredients and Combinationsa) Specific Active Ingredientsb) Combinations8.1.2 List of Restricted Active Ingredients and Combinationsa) Specific Active Ingredientsb) Combinations8.2 List of Prohibited and Restricted Excipients8.2.1 List of Prohibited Excipients8.2.2 List of Restricted Excipients8.3 List of Permitted and Restricted Colouring Agents8.3.1 List of Permitted Colouring Agents8.3.2 List of Restricted Colouring AgentsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 332
Drug Registration Guidance Document (<strong>DRGD</strong>)8.1 LIST OF PROHIBITED AND RESTRICTED ACTIVE INGREDIENTS ANDCOMBINATION8.1.1 LIST OF PROHIBITED ACTIVE INGREDIENTS ANDCOMBINATIONSa) Prohibited Active IngredientsNO.PROHIBITED ACTIVE INGREDIENTS1. Aristolochic Acid2. Aminopyrine/ Amidopyrine3. Astemizole4. Bacillus Coagulans5. Berberine6. Butobarbitone7. Chlormezanone8. Cisapride9. Conjugated Linoleic Acid10. Crinis Carbonisatus11. Danthron12. Dipyrone13. Enterococcus Faecalis14. Enterococcus Faecium15. Ethenzamide16. Euflavine17. Furazolidone18. Fenfluramine/ Dexfenfluramine19. Gentian Violet20. Gamma-Butyrolactone (GBL)21. Gamma-Hydroxybutyric Acid (GHB)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 333
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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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