NEW DELHI: Government banned 14 fixed-dose combinations (FDC) drugs that claim these may pose a “risk” to people. The move follows recommendations from a panel of experts who said there was “no therapeutic justification” for the ingredients in these FDCs and that they could pose “risk to humans.”
FDCs refer to the combination of two or more drugs in a fixed ratio to develop a single dosage form. According to an editorial published in the Indian Journal of Pharmacology in 2016, FDCs are justified when they demonstrate clear benefits in terms of therapeutic efficacy, reducing the incidence of adverse drug effects, improved compliance by reducing pill burden and decreasing the development of the pill. resistance among others .
The editorial, written by Dr YK Gupta, former head of the division of pharmacology at the All India Institute of Medical Sciences (AIIMS) and Dr Suganthi S Ramachandra, classified the FDCs available in India as “the good, the bad and the ugly the bad”.
“Good” FDCs have been defined as those that have a strong justification such as carbidopa + levodopa, sulfonamides + trimethoprim, antituberculosis drugs, antiretroviral drugs, some antihypertensive drugs, and some antidiabetic drugs. The “bad” FDCs were those formulated primarily with marketing interests and added no value to therapeutic utility and whose justification was questionable. Dr Gupta and his colleague said that most of the FDCs available in India fall into the “bad” category. Examples of these included a combination of two nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxants, and NSAIDs with H2 blockers. “Ugly” FDCs have been defined as those that have neither proof nor theoretical justification. These included formulations containing cough syrups with two or more antihistamines, + decongestant, + bronchodilator, + cough suppressant, + expectorant and antifungal, + antibiotic, + steroid, and + topical local anesthetic.
FDCs refer to the combination of two or more drugs in a fixed ratio to develop a single dosage form. According to an editorial published in the Indian Journal of Pharmacology in 2016, FDCs are justified when they demonstrate clear benefits in terms of therapeutic efficacy, reducing the incidence of adverse drug effects, improved compliance by reducing pill burden and decreasing the development of the pill. resistance among others .
The editorial, written by Dr YK Gupta, former head of the division of pharmacology at the All India Institute of Medical Sciences (AIIMS) and Dr Suganthi S Ramachandra, classified the FDCs available in India as “the good, the bad and the ugly the bad”.
“Good” FDCs have been defined as those that have a strong justification such as carbidopa + levodopa, sulfonamides + trimethoprim, antituberculosis drugs, antiretroviral drugs, some antihypertensive drugs, and some antidiabetic drugs. The “bad” FDCs were those formulated primarily with marketing interests and added no value to therapeutic utility and whose justification was questionable. Dr Gupta and his colleague said that most of the FDCs available in India fall into the “bad” category. Examples of these included a combination of two nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxants, and NSAIDs with H2 blockers. “Ugly” FDCs have been defined as those that have neither proof nor theoretical justification. These included formulations containing cough syrups with two or more antihistamines, + decongestant, + bronchodilator, + cough suppressant, + expectorant and antifungal, + antibiotic, + steroid, and + topical local anesthetic.
