WHO blames buyers for substandard ingredients

The coordinator for drug quality at the World Health Organization is putting much of the blame for substandard APIs on drugmakers, telling in-PharmaTechnologist that as long as there are companies willing to buy them, there are organizations willing to make them. China, which makes an estimated 40% of all of the active pharmaceutical ingredients used globally now, is often identified as the source of bad API products. Lembit Rägo says, "We cannot advise [pharmaceutical companies] not to source APIs from China. This would likely have devastating results for availability of many lifesaving medicines for alternative sources may not be available. Our efforts are to advise about API standards and how to implement and enforce these standards. This is relevant both for producing countries as well as countries, which purchase APIs from abroad, not talking specifically about China." He acknowledges that it will be a problem as long as there are countries that can't afford strict regulatory agencies and oversight. Story | More

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