Issue link: https://www.e-digitaleditions.com/i/1411460
Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 13 tentially dangerous drugs from the drug supply chain to protect US consumers." In an inter v iew, Justin D. Green, Of f ice of Criminal Investigations deputy director, FDA, added, "Our Office of Criminal Investigations w i l l continue to pursue a nd bring to justice t hose ma nu fac t u rers a nd i l l icit ac tors who would violate the public's trust and endanger their health by attempting to avoid the agency's oversight authority." However, estimating the scale of the problem of substandard and counterfeit COVID-19 vaccines is very challenging, WHO stated in an interview. "In a world of globalized supply chains, the r isk of subst a nd a rd /fa lsi f ied med ic a l prod- ucts a f fects a l l countries," WHO added. "In 2017, WHO released statistics based on surveys conducted over t he past 10 years, which sug- gest the failure rate of medicines sur veyed in LMICs [low- and middle-income countries] is approximately 10.5%"(8). Some of the challenges to the supply chain are in unregulated online marketplaces, said WHO in an interview, which has provided opportuni- ties for manufacturers and suppliers of substan- dard and falsified medical products to gain ac- cess to the global marketplace. WHO also added t hat self-diagnosis and self-prescribing have led to an increase in unregulated websites that claim to diagnose illness and provide access to substandard and falsified medical products. Where do we go from here? As of August 2021, Our World in Data estimates that approximately 1.2% of people in low-income countries have received at least one dose of the COVID-19 vaccine (1). Moreover, low- and mid- dle-income countries spend approximately $30.5 billion on substandard and falsified medicines, ac- cording to Member State Mechanism on Substan- dard and Falsified Medical Products (9). With an inequitable distribution of legitimate vaccines, particularly in low- and middle-income countries, where can the industry go from here? How can supply chain vulnerabilities be addressed on a global scale? WHO made the following recommendations in an interview: • "Member States are encouraged to work with WHO and procure via the COVAX system. • "National health regulatory authorities must coordinate with other key stakeholders of the supply chain. • "Traceability of medical products is an im- portant aspect of supply chain integrity. • "Effective and well-resourced national health regulatory authorities are essential to secure national and global regulated supply chains. • "It is crucial that national authorities are given appropriate powers to enforce regula- tions on the good distribution practice of medical products. • "Customs authorities must also be trained and made aware of the issue of SF [substandard and falsified] medical products and should "In a world of globalized supply chains, the risk of substandard/falsified (SF) medical products affects all countries." - WHO spokesperson