FIXED DOSE COMBINATION (FDC) DRUGS

About:

• Fixed Dose Combination (FDC) drugs includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.
  
  
• Common examples of FDCs: Cough syrups Phensedyl and Corex, Vicks Action 500.
  
  

Indian scenario:

• Kokate Committee: In India, FDCs were declared “irrational” by a Union Health Ministry expert committee set up in 2014 headed by former KLE University Vice-Chancellor, CK Kokate.
  
  
• Drug advisory sub-committee: Now, a sub-committee formed by Drugs Technical Advisory Board (DTAB) has asked pharmaceutical companies to submit “precise data” until June 30 to prove that 324 FDCs drugs are safe and effective for patients to consume.