Fixed-dose combination (FDC) is a combination of more than one Active Pharmaceutical Ingredient in a fixed ratio of dosage to form a single medicine.
Recently, the Government has decided to ban FDC’s due to threats posed by them on health. In this regard, Kokate Committee has to review the efficacy of 500 FDC (ii batch of drugs) in 2016, the committee banned 344 such combinations which include painkiller Saridon, and skin cream Pandcrm, antibiotic lupidiclox and much more due to concerns over them.
Concerns over FDCs —
- The inflexibility of dosing(Difference age group require different dosage).
- The multiplicity of the ingredient may confuse the physician about the exact dosage of one API.
- If wrongly estimated, may prove to be fatal.
- But it too has several advantages due to which banning them seems like a battle.
- Reduced pill burden
- Effective fast treatment of pain
- Low cost
However, the biggest concern is banning useful FDCs is more in the market while relativity worse FDCs are been reluctantly sold even today. This is due to
- An opaque regulatory system and ambiguity over licensing power.
- FDCs approved by CDCSO in disproportionately higher in comparison to USFDA (American drug approval body) where few hundred drugs are approved.
- Majority FDC lack scientific justification.
- Due to the banning of useful FDCs, many pharma agencies face problems like
- Filling petition in SC to quash ban
- Effect on sale and demand of drug.
- In general, public health may suffer.
- Start excelling illegally.
However, the battle is not only limited to the periphery of banning FDCs which greater risk on health like a failure of organs or chronic diseases may occur.
To conclude, the battle for FDCs is not far over if several measures are taken appropriately like –
- Process of reviewing rationality of new drug to be made more stringent.
- Irrational formulation to be banned.
- The more scientific approach for approving a new drug.
- Approval drugs are those only which are listed in WHO’s essential drugs list of 24 FDCs.