DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)b) Prohibited CombinationsNO.PROHIBITED COMBINATIONS1. Ampicillin + Cloxacillin2. Antibiotics + Papain/ Prolase3. Antacid + Charcoal4. Combinations With Any Barbiturates5.6.7.8.Combinations of Two or More Analgesic with the Same Mode ofActionCombinations Of Vitamin (S) With Other Drugs:a. Vitamin (S) + Appetite Suppressantb. Vitamin (S) + Corticosteroidc. Vitamin (S) + Analgesicd. Vitamin (S) + Laxativee. Vitamin (S) + Slimming AgentsCough, Cold and Allergy Products Containing:a. Four or More Pharmacological Groups in One Product.b. Two or More Drugs from the Same Pharmacological Groupc. Antypyretic - Analgesic + Expectorantd. Anticholinergic + Bronchodilatore. Codeine + Ephedrine/ Pseudoephedrinef. Methapyrileneg. Paracetamol + Mucolytic/ ExpectorantCombinations Containing Antacid and Surface Local AnaestheticAgent9. Combinations Containing Dextropropoxyphene10. Combinations Containing Spironolactone11. Corticosteroids + Antihistamines12. Eye Drops Containing Vitamin13. Gripe Water Containing Alcohol14. Propanolol + HydralazineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 332
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 (>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 | 333
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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