Regulatory Focus™ > News Articles > Report: Second Instance of Fake Avastin Highlights MHRA Troubles

Report: Second Instance of Fake Avastin Highlights MHRA Troubles

Posted 05 April 2012 | By Alexander Gaffney, RAC 

Another incident involving lots of fake bevacizumab (Avastin/Altuzan)-the second in as many months-is drawing attention to resource shortages at the UK's Medicines and Healthcare product Regulatory Agency (MHRA), reports Reuters.

The British healthcare product regulator currently oversees 1,800 wholesalers in the country-second in amount only to Germany, which oversees more than 3,000 wholesalers.

"We are concerned that the MHRA doesn't have sufficient resources to inspect all the premises that have a wholesale dealer license," said Malcolm West, a supply chain expert at the Association of the British Pharmaceutical Industry, to Reuters.

The lack of resources is preventing MHRA from undertaking regular inspections, which might otherwise discover the counterfeit drugs.

Lots of bevacizumab discovered in the US the week of 2 April did not contain the active ingredient, which would render the popular cancer drug useless.

An earlier counterfeit lot of the drug discovered by US regulatory officials in March also found the drugs to not contain the active ingredient. The Wall Street Journal reported at the time that MHRA had tipped off the US Food and Drug Administration (FDA) to that lot of Avastin.

The Reuters article also highlights what is known as "parallel trade"-importing a drug that is priced low in one country, and importing it to a country where the drug is sold for a higher price in a process known as arbitrage.

The practice, used by larger and smaller wholesalers alike, is making it difficult for MHRA to keep up with the high volume of drugs coming into and through the country, reports Reuters.

Read more:

Reuters - Fake drugs hard to spot amid 1,800 UK wholesalers

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