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Prescribing Nimesulide- Beware of these combinations


Prescribing Nimesulide- Beware of these combinations

The central government has banned many Nimesulide combinations after the DTAB recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in the said FDCs and that these FDCs may involve risk to human beings.

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 Nimesulide 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”. 

Read also: 328 FDC Medicines banned over safety concern: Health Ministry Notification

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 Nimesulide combination with immediate effect.

Following combinations of Nimesulide have been banned

S. no. Banned Nimesulide Combination by FDC Gazzate Number
1 Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide 985
2 Cetirizine + Nimesulide + Phenylephrine 943
3 Nimesulide + Certirizine + Phenylephrine 975
4 Nimesulide + Cetrizine + Caffeine 707
5 Nimesulide + Diclofenac 706
6 Nimesulide + Dicyclomine 730
7 Nimesulide + Loratadine + Phenylephrine + Ambroxol 860
8 Nimesulide + Paracetamol + Cetirizine + Phenylephrine 867
9 Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine 918
10 Nimesulide + paracetamol Injection 721
11 Nimesulide + Paracetamol Suspension 743
12 Nimesulide + Phenylephrine + Caffeine + Levocetirizine 864
13 Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol 719
14 Nimesulide + Serratiopeptidase 717
15 Nimesulide + Tizanidine 708

Read Also: Health Ministry bans 328 FDC Banned Drugs, check out the complete list



Source: self
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