Regulatory Focus™ > News Articles > Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

Posted 22 May 2012 | By

An article published in The LancetInfectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate packaging or veracity.

The National Institutes of Health (NIH)-funded study looked at 1,437 samples of malaria drugs from seven Asian countries and 2,634 malaria drugs from 21 countries in sub-Saharan Africa.

Of the samples obtained from the Asian countries, roughly 33% failed chemical analysis testing, half were packaged incorrectly and 36% were counterfeit. The African countries exhibited similar trends, with one third failing chemical analysis testing, and 20% of products proving to be counterfeit. Packaging analysis was not widely available, and was excluded.

The study attributed the failure of pharmaceutical quality to a number of factors, including insufficient regulatory infrastructure.

"[T]here is a lack of regulatory oversight of manufacturing and little punitive action for counterfeiters," both of which contribute to an environment in which counterfeit products proliferate, wrote NIH in a statement.

"These findings are a wakeup call demanding a series of interventions to better define and eliminate both criminal production and poor manufacturing of antimalarial drugs," said Dr. Joel Breman, one of the paper's co-authors.

Read more:

NIH - NIH study shows poor quality malaria drugs pose threat

PharmPro - Study: Fake Malaria Drugs Common in Asia, Africa

Reuters - Fake drugs threaten gains made in war on malaria

BBC - Third of malaria drugs 'are fake'

Times of India - 7% of malaria drugs in India fake: Study

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