One in 10 medical products substandard or falsified in developing countries

ISLAMABAD: An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from the World Health Organization (WHO). This means that people are taking medicines that fail to treat or prevent disease. Not only are substandard or falsified medical products a waste of money for individuals and health systems that purchase these products, they can also cause serious illness or even death.
Since 2013, WHO has received 1,500 reports of cases of substandard or falsified products from cancer treatment to contraception; these reports are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products, informs a press release.
Of these cases, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% each from the WHO Region of the Americas, and the WHO European Region.
This is just a small fraction of the total problem as many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region.
Prior to 2013, there was no global reporting of this information. Since WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices. WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported to WHO.  
In conjunction with the first report from the Global Surveillance and Monitoring System published most recently, WHO is publishing research that estimates a 10.5% failure rate in all medical products used in low- and middle-income countries.  
This study was based on more than 100 published research papers on medicine quality surveys done in 88 low- and middle-income countries involving 48 000 samples of medicines. Lack of accurate data means that these estimates are just an indication of the scale of the problem. More research is needed to more accurately estimate the threat posed by substandard and falsified medical products.  
Based on 10% estimates of substandard and falsified medicines, a modelling exercise developed by the University of Edinburgh estimates that 72,000 to 169,000 children may be dying each year from pneumonia due to substandard and falsified antibiotics. A second model done by the London School of Hygiene and Tropical Medicine estimates that 116,000 (64,000-158,000) additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa, with a cost of US$ 38.5 million (21.4 million – 52.4 million) to patients and health providers for further care due to failure of treatment.
  Substandard medical products reach patients when the tools and technical capacity to enforce quality standards in manufacturing, supply and distribution are limited. Falsified products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practice by wholesalers, distributors, retailers and health care workers. A high proportion of cases reported to WHO occur in countries with constrained access to medical products.