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”.
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|