The Ministry of Health and Welfare needs to take effective measures to ensure drug safety in Taiwan, in the wake of fake vaccine scandals and imports of Chinese medications containing problematic substances, Democratic Progressive Party (DPP) legislators and the Taiwan Medical Association said yesterday.
A series of fake vaccine scandals were reported in China last month, including an investigation that showed substandard diphtheria, pertussis, and tetanus (DPT) vaccines had been given to 215,184 children; a company found to have fabricated production and inspection records for about 113,000 doses of human rabies vaccines; and a vaccine maker that sold 400,520 inferior DPT vaccines in November last year.
A worldwide recall was also announced last month of a generic medication called valsartan — widely used to treat high blood pressure and heart conditions — after a Chinese-made ingredient was found to have likely been contaminated by a probable human carcinogen N-nitrosodimethylamine (NDMA).
Photo: Wang Yi-sung, Taipei Times
Two more Chinese drugmakers have said that a blood-pressure medication they exported to Taiwan contained NDMA, adding to the list of tablets being recalled.
The scandals have shaken public trust in the Chinese government, and Chinese social media posts expressed anger over the issue, while India has banned import of rabies vaccine from the problematic Chinese manufacturer.
DPP legislators Chiu Tai-yuan (邱泰源), Wu Kuen-yu (吳焜裕) and Chen Man-li (陳曼麗), along with association officials, said the ministry must establish effective mechanisms to ensure public drug and vaccine safety.
Association deputy secretary-general Chao Chien (趙堅) said Chinese medications containing NDMA had first been detected by health authorities in the EU and the US, so they hoped the Food and Drug Administration (FDA) would make more of an effort to examine drugs and safeguard the public from harmful substances.
The FDA should conduct a drug-injury survey to determine the status of patients who might have used the drugs that have been recalled, Wu said.
The lawmaker proposed amending the Pharmaceutical Affairs Act (藥事法) to increase the penalties for pharmaceutical companies that fail to adequately monitor the quality of ingredients used in their drugs.
FDA Medicinal Products Division Deputy Chief Chi Jo-feng (祁若鳳) said the problematic drugs were voluntarily recalled as soon as the agency received the information last month, and that the import permit of the ingredient has been banned.
Centers for Disease Control Deputy Director-General Philip Lo (羅一鈞) said most of the vaccines used in Taiwan are purchased from European nations and Japan.
None have come from China, he said, adding that all imported vaccines undergo thorough lot-by-lot inspection, so the public does not have to be worried about their quality.
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