Globalization of Drug Supply Carries Risks

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Globalization is everywhere. The world continues to become smaller and smaller, and the amount of goods, franchises and materials that are trades continues to increase. The fact that McDonalds has more than twice as many stores outside the US than within its borders is a clear indication of globalization. The amount of drugs that are traded also increases every year. In the US, imports comprise 40% of the drugs consumed and 80% of the ingredients needed to manufacture drugs.

While such trade bolsters the economies of many countries and lowers the price of medicines by creating competition, real risks have affected the supply chain. The rise of tainted and counterfeit medicines has affected every country. While the occurrences of these types of medicines are less than 1% in countries with strong and mature regulatory environments, developing countries have much larger problems and are as high as 30%. Worse yet, is that most of these compromised medicines are imported where identifying and tracking is even more challenging.

Earlier this year, the US FDA’s acting principal deputy commissioner, John Taylor, stated “the safety of America’s food and medical products is under serious challenge,” and that “another public health crisis like Heparin seems inevitable.” To refresh your memory, contaminants in Heparin led to over 140 deaths in 2008. Click here for more details.

We all have to face the reality that globalization has advantages as well as disadvantages, and the risk to the drug supply chain affects everyone. I, for one, am encouraged by the public comments that raise the awareness of this threat while also recognizing that it is a global problem. The threat to the drug supply chain is a problem that is bigger than any one person, supplier, agency or nation can handle. It is a global problem that must be tackled with a global solution.

Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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