EXPLAINER: What are fixed dose combination drugs and why are they a health risk

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This is not the first time such a ban was imposed by the health ministry - 14 combination drugs were prohibited in 2023, and 328 in 2018

The Centre has banned 156 fixed dose combinations (FDCs) drugs, including antibiotics, pain-relievers, and multivitamins, among others.

One of the banned FDCs include a combination of three drugs, such as levocetirizine(anti-histamine), phenylephrine (decongestant), and paracetamol (mild analgesic and antipyretic). Another is a combination of mefenamic acid (mild to moderate pain-killer) and paracetamol injection.

The ban was implemented on the advice of an expert committee appointed by the central government in line with the recommendations of the Drug Technical Advisory Board (DTAB), India’s highest advisory board on drugs. Both the committee and the board were of the opinion that prescribing FDCs lacked therapeutic justification and posed health risks.

This is not the first time such a ban was imposed by the health ministry —14 FDCs were prohibited in 2023, and 328 in 2018.

What are FDCs?

FDCs are combination drugs with two or more active ingredients. Active ingredients are the chemical components that exercise effect on the human body.

In a combination drug, all active ingredients are packed in a single pill or injection. These formulations are designed for health conditions such as tuberculosis and diabetes, which require intake of multiple medications daily. FDCs reduce the number of times patients need to medicate themselves.

However, combination drugs often incorporate and thereby facilitate unnecessary medication, posing a public health risk. The biggest of these is developing antimicrobial resistance, a condition in which microbes develop resistance to a drug due to its overuse.

Moreover, while the individual chemical ingredients may have therapeutic value, their combinations might not be compatible with each other due to differences in peak time and many other factors that could render the combination ineffective.

 

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