FIXED-DOSE COMBINATION (FDC) MEDICINES

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Context

• Fourteen fixed-dose combinations (FDC) medicines found to lack therapeutic relevance have been banned by the Central Government through a gazette notification.

FDC

• According to the Central Drugs Standard Control Organization (CDSCO), FDCs refer to products containing one or more active ingredients used for a particular indication(s).
• A medicine that combines two or more active drugs in a single dosage form such as a tablet or capsule.
• Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in a therapeutic effect, safety or compliance.

The recent ban

Reason behind ban of FDC

• The ban, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations.
• The expert committee said that there is "no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings.
• Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940.

Prohibited FDC medicines

• The Centre said an expert committee had recommended that “there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings”
  1. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
  2. 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 5 ml
  3. Phenytoin + Phenobarbitone Sodium
  4. Chlorpheniramine + Codeine Phosphate + Menthol Syrup
  5. Salbutamol + Bromhexine
  6. Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
  7. Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
  8. Nimesulide + Paracetamol dispersible tablets
  9. Amoxicillin + Bromhexine
  10. Pholcodine + Promethazine
  11. Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
  12. Chlorpheniramine Maleate + Codeine Syrup
  13. Ammonium Chloride + Bromhexine + Dextromethorphan
  14. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
• Earlier in 2016, the government had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court. The current banned 14 FDCs are also part of those 344 drug combinations.
• The Central Government is satisfied that it is necessary and expedient in the 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