14 FDCs prohibited.

S.O. 2394(E) The Central Government u/s26 A of the Drugs and Cosmetics Act, 1940 vide SO 2394 (E) prohibited the manufacture for sale, sale, and distribution for human use of drug fixed dose combination of 14 FDCs.

This is pursuant to the directions given by the Hon’ble Supreme Court of India in its judgment dated the 15th of December 2017 in the case of Union of India and Anr. v/s Pfizer Ltd. and Ors. Civil Appeal No. 22972 of 2017, inter alia, mentioning that in respect of 15 FDCs claimed to be approved prior to 1988, Central Government may, if it so chooses, de novo carries out an inquiry as to whether fixed dose combinations licensed prior to 1988 should be the subject matter of a notification under section 26A of the Drugs and Cosmetics Act,1940.

The matter was examined by an Expert Committee constituted by the Government of India which furnished its report on the 1st of April 2022 in respect of the above drug to the Central Government and Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940) agreed to the report submitted by the Expert Committee.

The Expert Committee recommended that “there is no therapeutic justification for this FDC 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.

In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended.

On the basis of the recommendations of the Expert Committee and the DTAB, the central government prohibits the manufacture for sale, sale, or distribution for human use of drug fixed dose combination of 14 FDCs with immediate effect.

Therefor the use of the below prohibited FDC can be prescribed by any doctor.

  1. Nimesulide, paracetamol dispersible tablet
  2. Amoxicillin, bromhexine
  3. Pholcodine, promethazine
  4. Chlorpheniramine maleate, dextromethorphan, guaiphenesin, ammonium chloride, menthol
  5. Ammonium chloride, bromhexine, dextromethorphan
  6. Chlorpheniramine maleate, codeine syrup
  7. Bromhexine, dextromethorphan, ammonium chloride, menthol
  8. Dextromethorphan, chlorpheniramine maleate, 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 syrup
  14. Salbutamol, hydroxy ethyl theophylline, bromhexine