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FDC Ban: Avoid These Combinations of Paracetamol


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

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  

 



Source: self
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