The health ministry is going to soon ban over 300 fixed-dose combination medicine. This decision has been made on the recommendation of a sub-committee of India's apex drug advisory body. The list of medications that could be banned include some popular OTC medicines as well. Some popular names included in the list are of cough syrups, flu medicined and painkillers that we could easily purchase over the counter like Saridon, D'Cold Total and Phensedyl. A total of 343 FDCs has been listed in the draft that the ministry plans to ban the manufacture, sale and distribution of. On the recommendations o DTAM( Drug Technical Advisory Board) the list has been prepared. It was last year that the Supreme Court had the DTAB for some suggestions of FDCs to the health ministry that could be banned or regulated the usage of. However, the final notification is yet to come, and the draft may be amended before the final one.
What are FDCs?
According to a medical research named Fixed dose drug combinations (FDCs): rational or irrational: a view point, "Combination products, also known as fixed-dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. The Food and Drug Administration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product’. It is widely accepted that most drugs should be formulated as single compounds."
Also, the study mentions the aspects on which rationality of FDCs be based on and they are:
- The drugs in the combination should act by different mechanisms.
- The pharmacokinetics must not be widely different.
- The combination should not have the supra-additive toxicity of the ingredients
The upcoming ban is a result of a long-drawn legal battle between the government and many of pharmaceutical companies. This battle is continuing since 2016 and it has been going on over the health ministry's decision to ban the drugs as they are deemed to be allegedly 'unsafe' or 'irrational'.