Responsible use of fixed-dose combination antibiotics in India
Authors: Pathiyil Ravi Shankar, Mohamed Azmi Hassali, Nisar A Shahwani, Qaiser Iqbal, Muhammad Anwar, Fahad Saleem
Journal: The Lancet Global Health (2016)

We value the efforts of Akram Ahmad and colleagues (August, 2016)1Ahmad A Khan MU Balkrishnan R Fixed-dose combination antibiotics in India: global perspectives.Lancet Glob Health. 2016; 4: e521Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar 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).2McGettigan P Roderick P Mahajan R Kadam A Pollock AM Use of fixed dose combination (FDC) drugs in India: central regulatory approval and sales of FDCs containing non-steroidal anti-inflammatory drugs (NSAIDs), metformin, or psychotropic drugs.PLoS Med. 2015; 12: e1001826Crossref PubMed Scopus (35) Google Scholar 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 antibiotic resistance by banning irrational FDCs.1Ahmad A Khan MU Balkrishnan R Fixed-dose combination antibiotics in India: global perspectives.Lancet Glob Health. 2016; 4: e521Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar 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.3Garari K Drugs banned in India to go abroad. Deccan Chronicle (Hyderabad).http://deccanchronicle.com/nation/current-affairs/170316/drugs-banned-in-india-to-go-abroad.htmlDate: March 17, 2016Google Scholar Within this context, WHO has approved only 350 formulations of FDCs to treat and prevent diseases, but more than 6000 combinations are available worldwide.3Garari K Drugs banned in India to go abroad. Deccan Chronicle (Hyderabad).http://deccanchronicle.com/nation/current-affairs/170316/drugs-banned-in-india-to-go-abroad.htmlDate: March 17, 2016Google Scholar 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,1Ahmad A Khan MU Balkrishnan R Fixed-dose combination antibiotics in India: global perspectives.Lancet Glob Health. 2016; 4: e521Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar 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. We declare no competing interests.