With reference to "Drug regulator may step up ban on FDCs" (September 29), we should applaud the government for taking the right decision in banning more fixed dose combinations (FDCs), often not found elsewhere.
Surprisingly, some of the multinationals do not market them in their home countries. When it is found unsafe or irrational for people in other countries, how can it be safe for Indians? FDCs are popular with pharma companies in India as they help circumvent drug prices and packaging regulations by adding an innocuous ingredient.
An area of concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions. It is a well-accepted principle in medicine that there is additional likelihood of adverse drug effects with FDCs compared to drugs given individually. Except for a few therapeutic areas where FDCs have pharmacological and clinical soundness, for the vast majority it is irrational and often injudicious.
These combinations are an easy way to sell two drugs when one (or even none) may be needed for the patient. FDCs without sound clinical data should not be marketed. Combination drugs should go through the same rigorous clinical protocol that a new drug does. The medical fraternity should support regulatory bodies to take urgent action and mitigate the free flow of irrational FDCs flooding India.
H N Ramakrishna, Bengaluru
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