DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)22. Haloquinol23. Hexachlorophene24. Mercurochrome25. Nimesulide26. Novobiocin27. Oxyphenisatin Acetate/ Acetophenolisatin28. Oxyphenbutazone29. Pergolide30. Phenacetin31. Phenazone/ Antipyrine- Propylphenazone- Isopropylphenazone32. Phenylbutazone33. Phenylpropalamine34. Piperazine35. Prenylamine36. Quinalbarbitone37. Salicylamide38. Sibutramine39. Stanozolol40. Sulphaguanide41. Thioridazine42. Tegaserod43. TerfenadineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 334
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 | 335
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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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