caspofungin br We value the efforts of Akram Ahmad and colle

We value the efforts of Akram Ahmad and colleagues (August, 2016) in highlighting an important issue related to the regulation of antibiotic fixed-dose combination drugs (FDCs) in India. Moreover, we agree with Ahmad and colleagues that actions taken by the Indian Government to ban irrational FDCs (combinations of two or more active drugs in a single dosage form that exposes patients to unnecessary risk of adverse drug reactions) are indispensable to protect public health. However, certain questions need to be considered if the issue of antibiotic FDCs is to be addressed at the global level. In India, 118 antibiotic FDCs are available, 80 (68%) of which are not registered with the Central Drugs Standard Control Organization (CDSCO). Therefore, in addition to placing a ban on antibiotic FDCs, the Indian Government must make sure that only evidence-based registered products enter the practice environment, and stern action should be taken on medicines and manufacturers not registered with CDSCO. Additionally, the Indian Government has taken a much needed step to restrict caspofungin by banning irrational FDCs. We find it surprising that although a ban on antibiotic FDCs is imposed in India, there is no ban on same drugs being exported to African or South Asian Association for Regional Cooperation countries. Their export is deemed legal if the importing country has no objections. Within this context, WHO has approved only 350 formulations of FDCs to treat and prevent diseases, but more than 6000 combinations are available worldwide. Therefore, if such irrational combinations are exported, the efforts of other countries towards quality use of medicines will be hindered. Direct or parallel export of banned FDCs should be strictly prohibited and monitored to prevent irrational use or misuse of medicines including antibiotics. Consequently, in addition to what is recommended by Ahmad and colleagues, we advise the Indian Government to rethink the policy of exporting banned FDCs and to monitor availability of unregistered products. We do agree that controlling antibiotic resistance in India is key for controlling antibiotic resistance worldwide; however, it does not make sense that strict measures could be taken in one region and that this very region could be responsible for promoting irrational antibiotic use in other areas. Antibiotic resistance is a global phenomenon and we need a global governance approach to address the issue.
Despite national and international recommendations that support influenza immunisation in pregnant women, global adoption of these programmes is inadequate. Reviews by public health experts of inactivated influenza vaccines have not identified safety concerns in pregnant women or their offspring. These reviews were based largely on non-product-specific data and observational studies because data from product-specific, randomised controlled trials in pregnant women are scarce. However, clinical trial data are the basis for the language of the vaccine product information and package inserts approved by regulatory authorities regarding indications, safety, and use in specific populations. Pregnancy is not a contraindication for use of most seasonal inactivated influenza vaccines prequalified by WHO for procurement by UN agencies. However, the WHO Strategic Advisory Group of Experts on Immunization raised concerns that overly precautionary language in package inserts regarding vaccine safety in pregnancy could contribute to hesitancy. We sought to evaluate the effect of the package insert language on the perceptions of providers of maternal health care on vaccine safety and use in pregnant women.
In in 2011, Johanna Crane argued for a “21st-century scramble for Africa by US universities”, as global health becomes “an increasingly hot field”. This popularity can be tracked, among other ways, through the increase of global health partnerships (GHPs). Research has helpfully explored power inequities between partner institutions, bureaucracy, misplaced research priorities, their (un)sustainability, and their potential to contribute to medical skills shortages in low-income and middle-income countries (LMICs). However, the research has also missed something crucial because it has not captured something far more basic and instructive: the geographies of GHP arrangements.