Why more than 300 combinations of medicines are banned in India?
We all know that the Health Ministry had banned the manufacture, sale and distribution of more than 300 fixed dose combinations (FDCs) drugs for human use. But do you know what are FDCs, why these medicines are banned in India etc. Let us find out through this article.
First we will study what is fixed dose combination (FDC)?
Fixed dose combination (FDC) medicines are a cocktail of two or more active drugs packed in a single dose. Nowadays these drugs are being banned by the government. Or we can say that combination products are also known as fixed dose drug combinations, they are combinations of two or more active drugs in a single dosage form. Usually they are given to improve patient compliance, as it is easier for the patient to take one drug rather than several and in some cases, for better therapeutic effects these drugs are given.
These drugs are in the form of painkillers, antibiotics, antiseptics for treatment of mouth and throat conditions and anti-diabetic drugs. Do you know that several FDCs are packed with a combination of nimesulide and paracetamol and are sold under different brand names like anti-pyretic or medications to control fever? India reportedly boasts around 2,000 FDCs, four times more that what is available in the US.
It is said that while making FDC drugs the combination should act by different mechanisms, the pharmacokinetics must not be widely different and the combination should not have supra-additive toxicity of the ingredients.
Have you ever thought that why these drugs became so popular?
The reason behind buying FDC or being so popular is cost. Instead of buying two or more separate medicines, a patient can buy just one FDC medicine to treat multiple illness symptoms, which is cost effective. In fact, pharma companies combine quickly the existing ingredients to make new products rather than discovering new drugs and manufacture them separately. In this way these drugs are cheaper for them. Another reason behind FDC circulation is pharma companies preferred them to circumvent price control. So, we can say to fulfil their commercial reason FDC medicines are flooded in the market.
Now, we will study why Government has banned FDCs medicines or drugs?
The health ministry took a decision when the Drugs Technical Advisory board recommended that "there is no therapeutic justification" for the ingredients contained in the banned FDC drug and that these medicines "may involve risk to human beings".
Also, health experts said that FDC combinations in the market neither boast any advantage over individual drugs nor are safe. In simple words, we can say that by taking FDC drugs, health risk will increase, may cause some side-effects, can make human body resistant to treatment.
Let us understand this with an example: When Nimesulide and Paracetamol is combined one new medicine is formed and it has no therapeutic advantage. Both the drugs act by same mechanism. But do you know that the combination may produce increased hepatotoxicity or liver damage. Antibiotic combinations are more critical, as irrational use may lead to adverse effects and the development of antibiotic resistance.
Most FDCs have the following demerits:
- Dosage alteration of one drug is not possible without alteration of the other drug.
- Differing pharmacokinetics of constituent drugs pose the problem of frequency of administration of the formulation.
- There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.
Now, we come to know about fixed drug combination, how they pose serious affect to the health etc.