FIXED DOSE COMBINATIONS (Syllabus GS Paper 2/3 – Health/Sci and Tech)

Context: The government has banned 156 fixed- dose combination (FDC) drugs, including popular medicines such as Cheston Cold and Foracet, used for cold and fever and pain respectively.

Fixed Dose Combinations

• About: These are medicines that have two or more active ingredients in a single pill, capsule or shot.
• Purpose: FDCs are designed to simplify treatment for patients with conditions requiring multiple medications, such as tuberculosis and diabetes.
• Example: Cheston Cold, an FDC, contains paracetamol, cetirizine, and phenylephrine—useful for multiple symptoms but unnecessary for conditions like bacterial infections.

Government Banning Certain FDCs

• Banning Reason: The government banned certain FDCs because they contain ingredients that may not work well together or are unnecessary when combined.
• Regulatory Concerns: Many banned FDCs were approved by state licensing authorities without adequate trials, as the individual ingredients were previously approved.
• Rising Antibiotic Resistance: The primary reason for banning these FDCs is to curb the misuse of antibiotics, which contributes to antibiotic resistance and necessitates stronger treatments for infections.

o Despite earlier bans, FDCs as a share of total antibiotics sold in India increased from 32.9% in 2008 to 37.3% in 2020.

• 2019 Regulation: The 2019 new drug and clinical trial rules classify FDCs as new drugs, requiring approval from the central drug regulator before use.