NEW DELHI: The government has banned 14 fixed-dose combination (FDC) drugs saying these may pose “risk” to people. The move follows recommendations of an expert committee that stated that there was “no therapeutic justification” for the ingredients contained in these FDCs and that it may involve “risk to human beings”.
FDCs refer to combining two or more drugs in a fixed ratio to develop a single dosage form. According to an editorial published in 2016 in Indian Journal of Pharmacology, FDCs are justified when they demonstrate clear benefits in terms of therapeutic efficacy, reducing the incidence of adverse effects of drugs, better compliance by reducing the pill burden and decreasing development of resistance among others.
The editorial, authored by Dr Y K Gupta, former head of pharmacology division at All India Institute of Medical Sciences (AIIMS) and Dr Suganthi S Ramachandra, classified the available FDCs in India as ‘the Good, the Bad and the Ugly’.
The ‘good’ FDCs were defined as ones having strong justification like carbidopa + levodopa, sulfonamides + trimethoprim, antitubercular drugs, antiretroviral drugs, some anti-hypertensive drugs and some antidiabetic medications. The ‘bad’ FDCs were the ones formulated primarily with marketing interests and did not add any value to the therapeutic usefulness and whose justification was debatable. Dr Gupta and his colleague claimed that majority of the available FDCs in India fell in the ‘bad’ category. The examples of these included a combinations of dual nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxant, and NSAIDs with H2 blockers. The ‘ugly’ FDCs were defined as ones that have neither evidence nor theoretical justifications. These included formulations having cough syrups with two or more antihistamines, + decongestant, + bronchodilator, + cough suppressant, + expectorant and antifungal, + antibiotic, + steroid and + topical local anaesthetic.
FDCs refer to combining two or more drugs in a fixed ratio to develop a single dosage form. According to an editorial published in 2016 in Indian Journal of Pharmacology, FDCs are justified when they demonstrate clear benefits in terms of therapeutic efficacy, reducing the incidence of adverse effects of drugs, better compliance by reducing the pill burden and decreasing development of resistance among others.
The editorial, authored by Dr Y K Gupta, former head of pharmacology division at All India Institute of Medical Sciences (AIIMS) and Dr Suganthi S Ramachandra, classified the available FDCs in India as ‘the Good, the Bad and the Ugly’.
The ‘good’ FDCs were defined as ones having strong justification like carbidopa + levodopa, sulfonamides + trimethoprim, antitubercular drugs, antiretroviral drugs, some anti-hypertensive drugs and some antidiabetic medications. The ‘bad’ FDCs were the ones formulated primarily with marketing interests and did not add any value to the therapeutic usefulness and whose justification was debatable. Dr Gupta and his colleague claimed that majority of the available FDCs in India fell in the ‘bad’ category. The examples of these included a combinations of dual nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxant, and NSAIDs with H2 blockers. The ‘ugly’ FDCs were defined as ones that have neither evidence nor theoretical justifications. These included formulations having cough syrups with two or more antihistamines, + decongestant, + bronchodilator, + cough suppressant, + expectorant and antifungal, + antibiotic, + steroid and + topical local anaesthetic.
