FDC Ban: Avoid These Combinations of Paracetamol
New Delhi: The Government of India recently prohibited the manufacture for sale, sale and distribution for human use, 328 fixed-dose combinations, many of which include Paracetamol after finding that these combinations have no therapeutic justification for the ingredients contained in this FDC.
The decision was announced after the matter has been examined by the Drugs Advisory Committee constituted by the Central Government said Committee has recommended to the Drugs Technical Advisory Board (DTAB ) in public interest recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Therefore, the only prohibition under Section 26A is recommended".
After examination of the recommendations of the said Committee, the Central Government announced that it was satisfied that it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale, sale and distribution for human use of the said drug in the country. Central Government while exercising the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940) has prohibited the manufacture for sale, sale and distribution for human use of the drug fixed-dose combination of different paracetamol combination with immediate effect.
Read also: 328 FDC Medicines banned over safety concern: Health Ministry Notification
Read Also: List of Banned Fixed Dose Composition drugs
The decision was announced after the matter has been examined by the Drugs Advisory Committee constituted by the Central Government said Committee has recommended to the Drugs Technical Advisory Board (DTAB ) in public interest recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Therefore, the only prohibition under Section 26A is recommended".
After examination of the recommendations of the said Committee, the Central Government announced that it was satisfied that it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale, sale and distribution for human use of the said drug in the country. Central Government while exercising the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940) has prohibited the manufacture for sale, sale and distribution for human use of the drug fixed-dose combination of different paracetamol combination with immediate effect.
Read also: 328 FDC Medicines banned over safety concern: Health Ministry Notification
| S.No | Banned Paracetamol Combination | Gazette Number |
| 1 | Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine | 1030 |
| 2 | Paracetamol + Caffeine + Codeine | 749 |
| 3 | Paracetamol + Caffine + Phenylephrine + Chlorpheniramine | 959 |
| 4 | Paracetamol + Cetrizine + Caffeine | 709 |
| 5 | Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine | 988 |
| 6 | Paracetamol + Codeine + Chlorpheniramine | 968 |
| 7 | Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine | 934 |
| 8 | Paracetamol + Dextromethorphan + Chlorpheniramine | 899 |
| 9 | Paracetamol + Diclofenac + famotidine | 718 |
| 10 | Paracetamol + Disodium Hydrogen Citrate + Caffeine | 746 |
| 11 | Paracetamol + DL Methionine | 747 |
| 12 | Paracetamol + domperidone + Caffeine | 739 |
| 13 | Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate | 952 |
| 14 | Paracetamol + Levocetirizine + Pseudoephedrine | 995 |
| 15 | Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine | 868 |
| 16 | Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine | 863 |
| 17 | Paracetamol + mefenamic Acid + ranitidine + Dicyclomine | 729 |
| 18 | Paracetamol + Pheniramine | 1001 |
| 19 | Paracetamol + Phenylephrine + Chlorpheneramine + Dextromethorphan + caffeine | 723 |
| 20 | Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate | 928 |
| 21 | Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol | 911 |
| 22 | Paracetamol + Phenylephrine + Levocetirizine + Caffeine | 932 |
| 23 | Paracetamol + Phenylephrine + Triprolidine | 905 |
| 24 | Paracetamol + Phenylephrine + Triprolidine + Caffeine | 953 |
| 25 | Paracetamol + Prochloperazine | 797 |
| 26 | Paracetamol + Prochlorperazine Maleate | 741 |
| 27 | Paracetamol + Promethazine | 790 |
| 28 | Paracetamol + Propyphenazone + Caffeine | 1036 |
| 29 | Paracetamol + Pseudoephedrine + Cetrizine | 726 |
| 30 | Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine | 888 |
| 31 | Paracetamol + Tapentadol | 733 |
| 32 | Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate | 1035 |
| 33 | Paracetamol+Pseudoephedrine+Certirizine+Caffeine | 969 |
| 34 | Rabeprazole + Diclofenac + Paracetamol | 845 |
| 35 | Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine | 1047 |
| 36 | Nimesulide + Paracetamol + Cetirizine + Phenylephrine | 867 |
| 37 | Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine | 918 |
| 38 | Nimesulide + paracetamol Injection | 721 |
| 39 | Nimesulide + Paracetamol Suspension | 743 |
| 40 | Naproxen + Paracetamol | 716 |
| 41 | Lornoxicam + Paracetamol + serratiopeptidase | 737 |
| 42 | Lornoxicam + paracetamol + Tramadol | 736 |
| 43 | Lornoxicam + paracetamol + trypsin | 728 |
| 44 | Levocetirizine + Paracetamol + Phenylephirine + Caffeine | 949 |
| 45 | Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol | 886 |
| 46 | Levocetirizine + Ambroxol + Phenylephrine + Paracetamol | 1005 |
| 47 | Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol | 980 |
| 48 | Flunarizine + Paracetamole + Domperidone | 832 |
| 49 | Dicyclomine + Paracetamol + Domperidone | 711 |
| 50 | Diclofenac + paracetamol + chlorpheniramine maleate + mgnesium Trisillicate | 725 |
| 51 | Diclofenac + Paracetamol + Chlorzoxazone + Famotidine | 715 |
| 52 | Diclofenac + paracetamol + magnesium Trisilicate | 738 |
| 53 | Diclofenac + Paracetamol injection | 751 |
| 54 | Diclofenac + Tramadol + Paracetamol | 714 |
| 55 | Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine | 929 |
| 56 | Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine | 965 |
| 57 | Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine | 947 |
| 58 | Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate | 871 |
| 59 | Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol | 887 |
| 60 | Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide | 985 |
| 61 | Caffeine + Paracetamol + Chlorpheniramine | 963 |
| 62 | Caffeine + Paracetamol + Phenylephrine + Cetirizine | 954 |
| 63 | Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol | 1039 |
| 64 | Acrivastine + Paracetamol + Caffeine + Phenylephrine | 915 |
| 65 | Aceclofenac (SR) + Paracetamol | 750 |
| 66 | Aceclofenac + Paracetamol + Famotidine | 744 |
| 67 | Aceclofenac + Paracetamol + Rabeprazole | 705 |
Read Also: List of Banned Fixed Dose Composition drugs
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