WHO announces pilot for insulin prequalification

Pharmaceutical Technology | November 14, 2019

WHO announces pilot for insulin prequalification
The World Health Organization (WHO) has launched a pilot programme for insulin prequalification to boost access to diabetes treatment. Under the two-year programme, primarily meant for low and middle-income countries, WHO will assess insulin developed by manufacturers for quality, safety, efficacy and affordability. It is in line with the organisation’s measures to address rising diabetes burden. Discovered nearly ten decades ago, insulin is required by patients with type 1 or type 2 diabetes. However, high prices are known to hinder access to the medication. WHO prequalification is intended to improve the availability of quality products on the international market, offering more options at lower prices. WHO director-general Dr Tedros Adhanom Ghebreyesus said: “Diabetes is on the rise globally, and rising faster in low-income countries. Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives.

Spotlight

On Nov. 27, 2013 President Obama signed the Drug Quality and Security Act into law, effectively setting the framework of what would become a nationwide initiative toward wide-scale pharmaceutical serialization. The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

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