Health Industry in Disarray Over Carcinogen in Generic Drugs

      July 11, 2018 12:43

      The health industry is in disarray over the import and sale of Chinese-made valsartan, which has been found to cause cancer. The Ministry of Food and Drug Safety on Monday banned the sale of 115 hypertension drugs containing valsartan from Zhejiang Huahai of China.

      Valsartan lowers blood pressure by suppressing the secretion of hormones that constrict blood vessels. The discovery of the carcinogen NDMA in Chinese-made valsartan seriously hurts the credibility and sales of Korean pharmaceutical companies that make their hypertension drugs with imported valsartan.

      According to the Ministry of Health and Welfare, 178,536 diabetes patients in Korea were prescribed the banned drugs. Other drugs containing valsartan are still being sold, raising fears that even more people may have been exposed to the carcinogen.

      The scandal erupted when the European Medicines Agency announced it found carcinogenic compounds in Chinese valsartan. The Ministry of Food and Drug Safety here swiftly followed suit by banning the production and sale of 219 pharmaceutical products that may contain valsartan. Health officials conducted on-site inspections and gave the green light to 104 products that did not contain valsartan.

      Patients wait to buy medicines in a drug store in Seoul on Tuesday. /Newsis

      Most of the banned products were generic versions of the hypertension drug Diovan manufactured by Novartis. Diovan does not contain Chinese-made valsartan and has not been banned.

      But many smaller Korean pharma companies that made generic Diovan are facing an emergency. According to market researcher Ubist, sales of the 115 types of banned hypertension drugs amounted to W39 billion based on prescriptions (US$1=W1,117).

      Most of them are small and mid-sized companies generating less than W100 billion in sales a year, and many are frantically contacting foreign drug makers hoping to boost their range of products, but the prospects are anything but rosy.

      Meanwhile patients who have taken the drugs are up in arms as they are now unable to get their prescriptions filled. Some pharma companies have recalled their products and discussing with hospitals how to supply replacements. But most of the drug makers simply have to wait for further instructions from the ministry.

      One staffer at a small pharma company said, "The cost of retrieving all of our products is overwhelming, so we're just standing by awaiting the final results of the ministry investigation."

      Fears may spread to other drugs since Korea has become extremely dependent on China for raw pharmaceuticals. According to the Korea Pharmaceutical Traders Association, Korea imported W2.06 trillion worth of raw materials for drugs last year, including W615.4 billion worth from China.

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