1 in 10 drugs in developing world fake, finds WHO

An estimated 1 in 10 drugs circulating in low- and middle-income countries – what are commonly known as the developing world – is either substandard or falsified, according to new research from the World Health Organization (WHO). However the figure for South Asia is 2%. While the report does not have India-specific figures, earlier surveys have thrown a 5-6% incidence of spurious/substandard drugs in the country.

Spurious drugs are those where the ingredients are different from what they are required to be. Substandard drugs on the other hand are drugs which are not efficacious either due to composition or other reasons.

“Substandard and falsified medicines particularly affect the most vulnerable communities. Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “.”

Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from sub-Saharan Africa, 21% from the Americas and 21% from the European region.

This is likely just a small fraction of the total problem and 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 Eastern Mediterranean and just 2% from the South-East Asia region.

The report notes that modern purchasing models such as online pharmacies can easily circumvent regulatory oversight. These are especially popular in high-income countries, but more research is needed to determine the proportion and impact of sales of substandard or falsified medical products.

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.

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 (21.4 – 52.4) million to patients and health providers for further care due to failure of treatment.

Globalization is making it harder to regulate medical products. Many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed. Sometimes, offshore companies and bank accounts have been used to facilitate the sale of falsified medicines.