DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)18. Diphenoxylate Liquid Oral Dosage For Anti-Diarrhoeal19. Quinestrol, Oestrogen Lactation Suppressant20. Ethynodiol Diacetate Oral Contraceptives21. Euphorbia Liquid Extract Expectorant22. Gatifloxacin All Preparations Except for Eye Drop23. Germanium Non Naturally Occurring24. Hydroquinone Oral25. Lactobacillus Acidophillus Antidiarrhoeal26. Loperamide Liquid Oral Dosage For Anti-Diarrhoeal27. Lovastatin In Red Yeast Rice: > 1 % w/w and >10mg/Day28. Lynooestrenol Oral Contraceptives29. L-Tryptophan All Preparations Except Parenteral NutritionProducts And Enteral Feeding Products30. Magnesium AscorbrylPhosphateAntipigmentation31. Menthol Analgesic: > 1.0%, Counter Irritant: >16%32. Mestranol Oral Contraceptives33. Methylene Blue Oral Preparations34. Midazolam All oral preparations, except 7.5mg coatedtablet35. Morphine Cough Mixtures36. Neomycin Oral Antidiarrhoeal, Vaginal Tablets, TopicalPowders, Aerosols, Nasal Preparations37. Noradrenaline Dental Preparations38. Norgestrel Oral Contraceptives39. Paracetamol Liquid Oral 500mg/5ml40. Penicillin Topical Use41. Phenazopyridine Urinary Analgesics42. Phenolphthalein Stimulant Purgative43. Pizotifen Appetite Suppressant44. Podophyllum Resin Oral Preparations45. Pseudoephedrine All Single Active Ingredient FormulationsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 328
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 | 329
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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