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European donors have made great efforts in recent years to improve the supply of medicines for diseases affecting the world’s poorest people, particularly malaria, tuberculosis (TB) and other deadly infections. But what if a small but significant proportion of these medicines are inferior? It would potentially undermine donor efforts and pose a grave threat to public health.
My team of researchers has carried out a significant study into drug quality. Over the past four years, we purchased 2652 samples of antimalarials, antibiotics and TB drugs from pharmacies in 19 cities across 17 developing and middle-income countries. The results are alarming: up to 15% of all drugs bought in African cities and 7% in Indian cities failed basic quality testing. In more detailed analysis of some of the malaria drugs, 40% of those bought in the two largest West African cities have insufficient active ingredient.
If a drug used to treat these diseases is not made to high standards, a sick patient is unlikely to recover and it increases the chance of malaria parasites or TB bacteria developing resistance to the treatment. This has the potential to render entire classes of medicines useless, making malaria or TB much more expensive to treat, and in a few instances untreatable with currently available medicines. Given that 8,8-million people contracted TB in 2010, and at least 240-million malaria, the public health consequences are dire.
Some of the substandard drugs we identified were most likely counterfeits.
But many more were made by local African, Indian or Chinese companies, but without the proper oversight of a competent government drug regulatory authority. Up to 25% of such drugs manufactured in Africa, 16% of those made in China and 4% of Indian drugs failed our testing, compared with 1,7% of those made in the European Union and the US.
More disturbingly, a small but significant number of poor-quality drugs we found had been quality-assured by the World Health Organisation (WHO), which does a pseudo-regulatory job for countries with little capacity. While drugs approved by the WHO are generally high quality, we found that some antimalarials, manufactured in China, were quite often inferior. Nearly 18% of the WHO-approved Chinese products we tested did not reach required standards, contrasting with a still worrying 2,4% failure rate of Indian-made WHO-approved products.
There are several reasons this may be happening. The most acute problem is with artemisinin combination therapies, a modern class of malaria drug.
One explanation is that recent global shortages of artemisinin (the main natural ingredient in the drug, derived from the sweet wormwood plant) have led to supply problems, which has resulted in many companies being forced to cut corners in order to deliver their medicines to agreed timetables. Another explanation is more sinister. It may well be that certain Chinese (and to a lesser extent Indian) drug manufacturers are boosting profits by cutting corners in the manufacturing process of drugs they supply to Africa. As the drug regulatory failures in India and China are well known, this is not so difficult for unscrupulous manufacturers to get away with.
In April, the Indian drug regulator was heavily criticised by the Indian parliament for colluding with drug manufacturers. Chinese authorities do not allow proper access to inspectors from overseas, resulting in audit reports indicating that more than a third of Chinese ingredients come from unknown sources.
Many African countries do not have the expertise or money to monitor properly the quality of drugs in their own markets and the WHO does not have the budget or ability to monitor the drugs it has approved once they have made it onto the market.
European donors must pressure Beijing and New Delhi to put their regulatory houses in order. After all, EU taxpayers pay for many of these Chinese and Indian drugs on behalf of the poor in Africa. Donors should expose and combat the double standard of companies exploiting weak oversight to sell poor-quality products to lower-income markets. In the face of such a threat to public health, inaction is not an option.
Dr Roger Bate is a resident scholar at the American Enterprise Institute and the author of Phake: The Deadly World of Falsified and Substandard Medicines.
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