DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.PROHIBITED COMBINATIONS15. Propanolol + Spironolactone8.1.2 LIST OF RESTRICTED ACTIVE INGREDIENTS ANDCOMBINATIONSSpecific Active IngredientsNot Allowed in the SpecifiedPreparation(s) or Condition1. Acetic Acid Expectorant2. Allantoin Eye Drop3. Allergen Extracts Vaccines, Diagnostics4. Amphetamine Cough Mixtures, Appetite Suppressants5. Animal Organ All Preparations Except Natural Products6. Antihistamine Topical Use7. Bismuth Salts ExceptBismuth SubcitrateOral Preparations8. Boric Acid/ Borax AndRelated SaltsOral, Topical (Skin), Vaginal, Nasal DosageForm9. Buprenorphine Single Active Ingredient Sublingual TabletFormulation10. Caffeine All Preparations Except for an OralPreparation in Combination withParacetamol/ Acetaminophen orCombination with Ergotamine11. Camphor - Oral- External (Analgesic > 3%, CounterIrritant >11%)12. Chloroform Expectorant13. Codeine Cough Syrup14. Cocillana Liq. Extract Expectorant15. Cyproheptadine Appetite Stimulant16. Dextromethorphan Single Active Ingredient in Tablet Form,including lozenges17. Dihydrostreptomycin Oral AntidiarrhoealsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 336
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 | 337
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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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Page 286 and 287: Drug Registration Guidance Document
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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