$30.5 bn worth drugs in low, middle income nations substandard: WHO

 Joe C Mathew   New Delhi     Last Updated: December 1, 2017  | 13:32 IST
WHO study suggests $30.5 billion worth drugs in low and middle income nations may be substandard and falsified products

One tenth of the medicines sold in middle and low income country markets could be of doubtful quality or dubious legal status, says a recent World Health Organisation (WHO) report. It estimates the value of such substandard or falsified medical products to be $30.5 billion. The findings have been questioned by civil society groups. A Malaysian NGO, Third World Network, termed the report as something that is based on "questionable data, lacking rigorous analysis".

Also called "out of specification", substandard products are authorized medical products that fail to meet either their quality standards or their specifications, or both. Medical products that are deliberately or fraudulently misrepresent their identity, composition or source are termed as falsified products.

WHO acknowledges that the report is not based on any primary data or research. The authors have picked up the conclusions of 100 different published research papers that had looked into the problem of medicine quality through surveys or field studies across the world. On the whole, the test results of 48,218 samples of medicines collected from 88 countries have been considered by WHO to arrive at this conclusion. "If this is even approximately correct, it highlights the urgent need to address this problem. It also highlights the need for better data on expenditure at country level to enable a more accurate estimate of the economic burden on these countries", the study notes.

The report states that studies that focus exclusively on anti-malarials, by far the most common among the 100 papers reviewed, provide a combined observed failure rates of 11.8 percent for substandard and falsified samples. "The lowest prevalence of substandard and falsified medicines was recorded in the studies testing multiple classes of medical products, often from multiple regions. Most of the products tested in "other single categories", were genitourinary and sex hormone drugs, where the specific observed failure rate was very high: 56%. In this same subset, the observed failure rate was also high among 104 antiepileptic medicines tested, with 65% failure. This may help explain the overall high percentage that failed testing", it says.

The WHO analysis, "A study on the public health and socioeconomic impact of substandard and falsified medical products", was released along with another report on "WHO Global Surveillance and Monitoring System for substandard and falsified products"  to outline the impact that substandard and falsified medical products can have on individuals, families, national health systems and the economy.

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