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The Central Ministry prohibits 14 Fixed Dose Combination Drugs (FDCs) in India.


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Importer & Manufacturer   |   CDSCO
02 June, 2023
Enforcement Date: 02 June, 2023
The Central Ministry prohibits 14 Fixed Dose Combination Drugs (FDCs) in India.

On 2nd June 2023, the Central Government published a notification in the Official Gazette. It states that due to "no therapeutic justification" and potential risk to patients, 14 fixed dose combination drugs are therefore prohibited for manufacture, sale, and distribution for human use.


Based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government has prohibited the following Fixed Dose Combination Drugs (FDCs)-

  1. Nimesulide + Paracetamol dispersible tablets
  2. Amoxicillin+ Bromhexine
  3. Pholcodine+ Promethazine
  4. Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
  5. Chlopheniramine Maleate + Codeine Syrup
  6. Ammomium Chloride + Bromhexine + Dextromethorphan
  7. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
  8. Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
  9. Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
  10. Salbutamol + Bromhexine
  11. Chlorpheniramine + Codeine Phosphate + Menthol Syrup
  12. Phenytoin + Phenobarbitone sodium
  13. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup
  14. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine

Applicable For: Importer & Manufacturer
Reference Number: CG-DL-E-02062023-246249 Notification Link

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