Fixed-dose combination drugs are produced when two or more active drugs combine in a fixed ratio into a single dosage.
• For example, a combination of Nimesulide and Paracetamol that is prescribed as an anti-pyretic (used to prevent or reduce fever).
• Cough syrups, Phensedyl and Corex, the widely advertised Vicks Action 500, antibiotic combination Zimnic AZ are some of the popular FDCs, which involve commonly used medications such as Paracetamol and Nimesulide.
The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective.
• FDCs are used in the treatment of a wide range of conditions and are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.
• FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio of doses has been shown to be safe and effective and when all of the actives contribute to the overall therapeutic effect.
• In addition there can be real clinical benefits in the form of increased efficacy
• Potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently
• Simpler logistics of distribution
• Improved patient adherence
However Government of India has banned 344 fixed dose combinations as it was found that the available FDCs in India are without any therapeutic use. A lot of FDCs sold in India are unapproved, given the lack of coordination between state and central regulators. A study published in the journal of Public Library of Science (PLOS) in May found that over 70% of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used as painkillers, were being marketed in India without central government approval. There were also concerns about developing resistance against FDCs and decrease in physical immunity in the long run.
These drugs have dangerous side-effects and that many of these combinations do not have any advantage over the individual drugs.
They pose a risk to humans and there are safer alternatives available in the market. The combination is not approved for sale in major pharmaceutical markets, including the United States, United Kingdom, Germany, France and Japan.