CDSCO prohibits / restricts manufacture, sale and distribution of 328 Fixed Dose Combination Drugs (FDCs)

CDSCO prohibits / restricts manufacture, sale and distribution of 328 Fixed Dose Combination Drugs (FDCs)

September 18, 2018 EHS, Healthcare, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (“CDSCO”) has prohibited manufacture, sale or distribution of 328 Fixed Drug Combinations (“FDCs”). The prohibition was imposed on 7th September 2018, by virtue of Notification Nos. S.O. 4379(E) to S.O. 4706(E).

Background

The prohibition has been imposed on the FDCs on the recommendations of Drugs Technical Advisory Board. There is no therapeutic justification for the ingredients contained in 328 FDCs and they were likely to involve risks to human beings.

The following are some of the FDCs that have been prohibited from being manufactured, sold or distributed:

  1. Nimesulide + Loratadine + Phenylephrine + Ambroxol
  2. Nimesulide + Phenylephrine + Caffeine + Levocetirizine
  3. Paracetamol + Pheniramine
  4. Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine
  5. Caffeine + Paracetamol + Phenylephrine + Cetirizine

The following are some of the FDCs on which restrictions have been imposed on their manufacture, sale or distribution:

  1. Glibenclamide + Metformin (SR) + Pioglitazone – S.O. 4712(E).
  2. Glimepiride + Pioglitazone + Metformin – S.O. 4711(E).
  3. Paracetamol + Prochlorperazine – S.O. 4710(E)
  4. Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 mg – S.O. 4709(E)
  5. Paracetamol +Prochlorperazine Maleate – S.O. 4708(E)

Source: Central Drugs Standard Control Organization

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