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Quality pharmaceutical products are global issues
by Eui Kyoung Yoon (ekyeun@dreamdrug.com)
Published : Jul 14, 2012 11:54:03
DailyPharm met Johan Vandenbrouke, former president of International Society of Oncology Pharmacy Practitioners to discuss quality control of generic drugs as most of brand-name drugs are going off patent.

Q: What’s the purpose of your visit to South Korea?
A: Pfizer Vitals invited me for some lectures about quality control and drug shortage.

Q: Quality control (over generic drugs) is getting more and more important. Is it because it has been an issue for a while?
A: There have been several quality control issues as some drugs didn’t meet requirements for good manufacturing practice. 426 recalls were reported in the U.S. in 2008 and 1,724 recalls in 2009, one year later. Ranbaxy was warned by the U.S. Food and Drug Administration because it didn’t follow cGMP and Baxter had to recall its heparin after 19 deaths and 350 adverse reactions were reported due to contaminated raw materials.

Q: Why do global pharmaceutical companies focus more on quality control?
A: Because the pharmaceutical industry is going global. A drug can be manufactured in United Kingdom, packaged in China, repackaged in some other country and then marketed in Belgium. It is harder to guarantee the product quality due to globalization.

Q: Do you think developing countries has more issues about quality control?
A: Not necessarily. Although a drug is manufactured in a developing country without meeting the manufacturing requirements, the regulator may not catch it because the whole system is very loose.

Q: How can the developing countries handle the failure of quality control?
A: The internationally-unified manufacturing standards will help. If all the medications are manufactured under the same standards owing to pharmaceutical companies’ efforts, quality drugs can be distributed all over the world.

Q: Is it possible to set global manufacturing standards?
A: World Health Organization and United Nation are working on them. PIC/S(Pharmaceutical Inspection Co-operation Scheme) started sharing GMP information and approving quality control systems among its member countries, including the U.S., United Kingdom, France, Germany, Finland, Belgium, Austria, Canada, Netherlands, Norway, and so on.

Q: We have Korean Good Manufacturing Practice (KGMP), but all the pharmaceutical companies prefer manufacturing standards from the U.S. or Europe.
A: There should be only one kind of manufacturing standards. Although western countries specify the standards with more details, the definitions should be the same.

Q: Do you think that generic drug business by big pharmas like Pfizer will help improve the quality of generic drugs?
A: Pfizer has accumulated knowledge on quality control of medications. If it applies its high standards to generic drugs, it will be a big step. Multinational companies’ solid financial status also helps the long-term stability of generic drug business.

Q: What if big pharmas don’t invest in R&D because their generic drug business continue to bring huge profits?
A: If they make profits from generic drugs, they can use the money for new drug development. Recently it takes shorter to commercialize a new drug these days, but more money to complete the process.

Q: As big pharmas enter the generic drug business, local drugmakers may be affected.
A: It doesn’t matter much. The number of drugmakers is increasing. The most important thing is stable drug supply. How many companies manufacture the drug doesn’t matter.

Q: What can physicians and pharmacists do to improve the quality of drugs?
A: We should focus on patients. We should pursue the way that high quality drugs can be supplied with long-term stability. Low quality drugs don’t help patients much. At the same time, it would not help them if high quality drugs are too expensive to purchase. Both quality and price are important.

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