FOOD AND DRUGS ADMINISTRATION PUDUCHERRY

Fixed Dose Combinations ( FDC )

Fixed Dose Combination (FDC) is a combination of two or more pharmaceutically active ingredients to make a single dosage which is prescribed in a fixed dose. FDC improves the efficacy of a medicy of a medicine thus reducing the number of pills taken by the patient. When two drugs combine, they become a new drug which require approval and license for manufacture. The license is approved by the State Drug Controller, and approval is provided by the Drug Controller General of India (DCGI). Presently, 294 FDCs are pending for approval by the DCGI after the licenses were issued from State Drug Controller. Out of the 294 FDCs, 78 FDCs are liable to get approval by the DCGI under certain conditions. The list of those 78 FDCs is as given below:
S. Name of FDC No. 1. 2. 3. 4. 5. 6. 7. 8. 9. Ibuprofen + Colchicine Category Orthopedics Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Should be Topical Remarks

Aloe extract + Allantocin + Alfa tocoferal acetate Dermatologicals + D-panthemol + Vit A Allantoin + Vit-E + Cammelina Sinensis Aloe extract + Vit-E + Dimethicone + Glycerine Aloe vera + jojoba oil + Vit-E Aloe vera + Orange oil Aloe vera + Vit-E acetate Aloe + tocopherol Dermatologicals Dermatologicals Dermatologicals Dermatologicals Dermatologicals Dermatologicals

Aloe vera + Glycerine + PFG 100 stearate + Vit- Dermatologicals E Dermatologicals Dermatologicals Orthopaedics Orthopaedics Orthopaedics Gastrointestinal Gastrointestinal

10. Aloe vera + Jojoba Oil + Wheat germ oil + Tea tree oil 11. Aloe vera + Vit-E + Herbal 12. Chlorzoxazone + Nimesulide 13. Chlorzoxazone + Paracetamol 14. Diclofenac + Tizanidine 15. Drotaverine hydrochloride + Mefenamic acid 16. Drotaverine + Mefenamic acid

17. Drotaverine + Nimesulide 18. Ibuprofen + Dextropropoxyphene 19. Ibuprofen + Tizanidine 20. Mecobalaminalphalipoic Acid + Folic acid + Vit B6 + Choline 21. Mecobalamine + Alpha lipoic acid 22. Mecobalamine + Alpha lipoic acid + Folic acid 23. Mecobalamine + Alpha lipoic acid + Vit B1 + Folic acid. 24. Mecobalamine + Biotin 25. Mecobalamine + Calcium panothenate

Gastrointestinal Orthopaedics Orthopaedics Nutritionals Nutritionals Nutritionals Nutritionals Nutritionals Nutritionals Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V Doses of Vitamins should be as per Schedule V

26. Mecobalamine + Carotinoid + Alpha lipoic acid + Nutritionals Chromim + Vit B1 + Vit B Complex 27. Mecobalamine + Folic acid 28. Mecobalamine + Methenamine mandelate 29. Mecobalamine + Vit-A + Vit-E + Vit-C + Vit-B1 + Vit-B6 + Vit-D3 + Selenium 30. Mecobalamine +Vitamins + Minerals 31. Mecobalamine + Vit-B1 + Vit-B2 + Vit-B6 + Folic acid 32. Mecobalamine + Vit-B1 + Vit-B6 + Folic acid + Alpha lipoic Nutritionals Nutritionals Nutritionals Nutritionals Nutritionals Nutritionals

33. Mecobalamine + Vit-B1 + Vit-B6 + Nicotinamide Nutritionals + D-Panthenol 34. Mecobalamine + Vit B6 + Folic acid Nutritionals

35. Acetylcysteine + Selenomethionone + choline Nutritionals Bitartrate + Pyridoxine + Folic Acid+Vitamin E + Cyanocobalmin + Chromium Nicotinate + Manganese Sulfate + Zinc Sulfate 36. Acriflavine + Gentain violet + Brilliant green 37. Alendronate sodium + Calcium carbonate + VitD3 38. Allantoin + Triclosan + Vit-E + Zinc Oxide 39. Drotaverine + Paracetamol 40. Ibuprofen + Paracetamol + caffeine 41. Ibuprofen + Pseudoephedrine + Chlorpheniramine 42. Metoclopramide hydrochloride + Paracetamol 43. Acetyl salicylic acid + Ethoheptazine 44. Norfloxacin + Ornidazole Dermatologicals Orthopaedics Dermatologicals GI Cough & Cold Cough & Cold GI Analgesics GI

Should be topical

Should be topical

45. Ofloxacin + Tinidazole 46. Aceclofenac + Tramadol 47. 5-bromosalicyl-4-chloranilide + salicylic acid 48. Ofloxacin + Prednisolone 49. Lansoprazole + Amoxycillin + Clarithromycin 50. Lansoprazole + Amoxycillin + Tinidazole 51. Lansoprazole + Tinidazole + Clarithromycin 52. Ornidazole + Flucanazole + Azithromycin 53. Clinamycin + Clotrimazole + Metronidazole 54. Mupirocin + Metronidazole 55. Benfotimine + Pyridoxine + Mecobalamine + Inositol + Alphalipoic acid 56. Amoxycillin + Clavulanic acid + Lactic acid bacillus 57. Amoxycillin + Clavulanic acid + Lactobacillus 58. Amoxycillin + Lactic acid bacillus 59. Amoxycillin + Lactobacillus 60. Amoxycillin + Lactobacillus acidophilus 61. Amoxycillin + Lactobacillus acidophilus + Clavulanic acid 62. Ampicillin + Lactic acid bacillus 63. Cefadroxyl + Lactic acid bacillus 64. Cefdinir + Lactic acid bacillus 65. Cefixime + Lactic acid bacillus 66. Cefixime + Lactobacillus acidophilus 67. Cefixime + Lactobacillus acvidophilus 68. Cefpodoximeprozetil + Lactic acid bacillus 69. Cefpodoxime + Lactic acid bacillus 70. Cefpodoxime + Lactobacillus 71. Cefprozil + Lactobacillus 72. Doxycycline + Lactobacillus

GI Orthopaedics Dermatologicals Opthalmic GI GI GI Antimicrobial Dematologicals Dematologicals Nutritionals Should be topical Should be opthalmic solution Should be combipack Should be combipack Should be combipack Should be combipack Should be topical Should be topical Doses of Vitamins should be as per schedule V Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day

Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial

73. Lincomycin + Lactobacillus 74. AmoxicillinCloxacillin + Lactic acid bacillus 75. Amoxicillin + Cloxacillin + Lactic acid bacillus 76. Amoxicillin + Cloxacillin + Lacto acid bacillus 77. Ampicillin + Cloxacillin + Lactic acid bacillus 78. Cefixime + Lactobacillus + Clavulanic acid

Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial Antimicrobial

Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day Dose of lactobacillus should be 5 billion per day