Clarification on study of TB Drugs

Editor,In response to The New Times’ article on 7 February, the Ministry of Health would like to clarify its position on the challenge of falsified and sub-standard drugs in Rwanda. An international study of anti-tuberculosis drug quality that was published last month included Rwanda as one of 17 countries across four continents where drugs were randomly purchased and analysed using sophisticated biochemical techniques. It is very important to note that the 17 countries were included to provide a wide range of settings, not because they were identified as having a particularly high risk of falsified medicines. The data reported in the study were aggregated by region; meaning that the finding that one-sixth of drug samples in Africa were fake or sub-standard combined all data from 11 African countries, including Rwanda. This data was collected in a very scientific manner, but because information for individual countries was not reported, it was not possible to assess implications at the national level.The study’s lead investigator, Roger Bate of the American Enterprise Institute, has since shared his team’s data on Rwanda with the Ministry of Health, where it was found that none of the 13 Rwandan samples in the study was fake. One of the 13 samples was degraded (likely due to humidity), a challenge that would be visually detected by a trained pharmacist in most cases. These findings suggest that the regulations and systems put in place by the Ministry of Health, Rwanda Biomedical Centre, and the Rwanda Bureau of Standards are working well to ensure that no falsified medicines enter our health sector. These include restrictions on the sale of tuberculosis drugs in the private sector, importation only from manufacturers approved by the World Health Organisation, and drug quality spot checks conducted with partners by the Ministry’s Pharmacy Task Force. High treatment success rates for both drug-susceptible and multidrug-resistant tuberculosis in Rwanda are also positive signs.The new Food and Drug Medicines Authority will soon assume primary responsibility for quality control of drugs for tuberculosis and many other diseases in Rwanda. Working across agencies and with international partners, Rwanda’s ability to guard against fake medicines should continue to improve in the coming years. Yet, fake medicines are a major global challenge, and action only at the national level cannot permanently address the problem. For this reason, Rwanda is committed to working with the East African Community on a regional anti-counterfeit law that will introduce new safeguards against falsified drugs while protecting access to high quality generics.Agnes BinagwahoMinister of Health

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Clarification on study of TB Drugs