Pharmaceutical Technology - September 2021


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12 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Drug Safety Who is at greatest risk? The Medicine Quality Research Group, Centre of Tropical Medicine & Global Health, Nuffield Department of Medicine, and the University of Oxford published a report in April of 2021, which stated that low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines (3). In Ma rch of 2021, Mex ic a n aut hor it ies at Ca mpech Internat iona l A ir por t fou nd 5775 doses of counterfeit sputnik v vaccines (which conta ined spel ling errors) in a n icebox t hat were due to be t ra nspor ted to Hondu ras by plane (3). In addition, in April of 2021, Pfizer identified falsified COVID-19 vaccines in Mex- ico and Poland, according to an article in The Wall Street Journal (4). There were fraudulent labels on the via ls in Mexico, while the via ls in Poland contained a treatment for wrink les, Pf izer stated (4). Approximately 80 people in Mexico were believed to have received these fal- sified vaccines. More recently, in July of 2021, a n est i mated 250 0 people i n Ind ia t houg ht they were receiving coronavirus vaccines and instead were injected with saline, according to an article on (5). In the same article, a senior official of the Mumbai police depart- ment shared there were at least 12 fake vaccina- tion drives in Mumbai (5). But the counterfeit vaccines didn't just start cropping up in 2021. Yet anot her example of counterfeit COVID-19 vaccines, according to an article in The Wall Street Journal, was in No- vember of 2020 when authorities in Germiston, South Africa uncovered 2400 doses of falsified vaccines in 400 ampuls in a refrigerator (6). US vs. global supply chain security The US drug supply is among the safest in the world, according to FDA's website, which states that there is a closed drug distribution system a nd fa lsif ied d r ugs in t he United States a re rare—relative to t he number of prescription drugs used (7). FDA works with U.S. Customs a nd Border Protec t ion to mon itor subst a n- dard and falsified drug products that are made abroad and distributed in the US. "Drugs prescribed for patients must be pure, sterile, and produced in an FDA-compliant fa- cility that is within the supply chain that FDA oversees," said an FDA spokesperson in an in- terview. "Since 2013, the FDA has operated an electronic, interoperable system that identifies and traces certain prescription drugs as they are distributed in the US. This system enhances the FDA's ability to help protect consumers from ex- posure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The sys- tem also improves detection and removal of po- "Our Office of Criminal Investigations will continue to pursue and bring to justice those manufacturers and illicit actors who would violate the public's trust and endanger their health by attempting to avoid the agency's oversight authority." —Justin D. Green, OCI deputy director, FDA

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