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  • br On March the Indian Government

    2019-05-24


    On March 10, 2016, the Indian Government banned around 330 “irrational” fixed-dose combination drugs (FDCs) with immediate effect. FDCs are products that buy WEHI-539 contain two or more active drugs in a fixed-dose ratio, and are useful for minimising pill burden and lowering cost. However, FDCs should ideally contain constituents that act via different mechanisms and do not cause additive toxic effects. An FDC is described as irrational if these conditions are not met. The government\'s decision was influenced by reports expressing concern about the safety and efficacy of FDCs manufactured in India. In view of the substantial financial loss to industry, some pharmaceutical companies have taken legal action to exempt their FDCs from the ban. However, we believe the government\'s action was necessary to safeguard public health. 63 (19%) of the 330 banned FDCs are antibiotics. Antibiotic resistance is of increasing concern worldwide, but initiatives to curtail inappropriate use have had little success. Studies of several antibiotic combinations, such as meropenem and sulbactam, have reported no additional advantage over their individual constituents, and have been reported to cause toxic reactions and promote resistance. Despite repeated investigations into the shortcomings of some FDCs, such drugs are still being manufactured and promoted on the Indian drug market. 118 antibiotic FDCs are available on the Indian market, 80 (68%) of which are not registered with the Central Drugs Standard Control Organisation. The regulation of FDCs of antimicrobials in India is important from a global perspective. The growth of worldwide trade and travel has allowed resistant microorganisms to spread rapidly to distant countries and continents. New Delhi metallo-β-lactamase, an enzyme that causes bacteria to be resistant to antibiotics, was first reported in India in 2008 and is now found worldwide. Moreover, FDCs that have been banned in India have been reported to be exported to other African and Asian countries. Such exports are a setback for the individuals or organisations trying to implement antimicrobial stewardship initiatives in these settings. Inadequate knowledge of physicians about FDCs is also an exacerbating factor in antibiotic resistance.
    In 2010, the UN\'s Population Division predicted that the African continent, the population of which is now 1·2 billion, will have 3·5 billion people by the year 2100. By 2015, the projection for the year 2100 had risen to 4·4 billion. In many ways this is good news for Africa—the population increase reflects impressive progress in reducing mortality, especially child mortality, and improving life expectancy. But the response to the news in developed countries has been of concern, often turning into panic. John Bongaarts, vice president of the Population Council, warned that “Most of these people are going to end up in slums. That\'s not good news.” Mertule Mariam said: “Alarmingly, population growth in Africa is not slowing as quickly as demographers had expected…the number of Africans seeking a better life in Europe and other richer places is likely to increase several times over”. These reactions have revived discussions in developed countries on what should be done to alleviate the apparent crisis. Policy prescriptions in developed countries focus on family planning services and education of girls. These recommendations might be sensible, but if Africans do not take the lead in framing the population discourse, their motivations and needs could be overlooked. New policies must consider African development.
    South Asia has a high incidence of chronic kidney disease (CKD). Bogdan Ene-Iordache and colleagues (May, 2016) reported findings from 75 058 people from 12 countries, including three south Asian countries, in which only 6% of the general population and 10% of high-risk populations surveyed were aware of their CKD status. Besides this low level of kidney health awareness, we identify additional challenges, in particular for end-stage kidney disease (ESKD), which are important to the south Asian population.