Medicine investigation enters stage 2: Food and Drug Administration


By Stephanie Chao ,The China Post

TAIPEI, Taiwan — The Food and Drug Administration (FDA, ���ĸp) announced yesterday that it will commence the second stage of investigations into 90 pharmaceutical firms, among which are 60 to 70 PIC/S GMP certified firms. Results are estimated to come out within a week.

Thirteen pharmaceutical firms were found using food-grade ingredients in 23 products, during the first stage of investigations. The firms were unable to prove the ingredients were pharmaceutical-grade magnesium carbonate and calcium carbonate.

Taiwan Veterans’ (�a���s��) Taisho Granule (�j���G�z��), Grape King’s (������) Hiweikean Granules Grape (�R�G�d����) and Min Tong’s (���q�s��) Couweiton Granules (�x�G������) are among the fake medicine announced by the FDA.

The FDA also reported that Yuncheng Chemical (�����Ƥu) and I Hsing Trade Company (�˿��T��) had been providing downstream companies with excipients made with more than the regulated level of chemicals, such as magnesium carbonate, arsenic, iron, calcium oxide and acid-insoluble residual.

FDA chief Chiang Yu-mei (������) responded saying that all illegal products using food-grade ingredients must cease to be manufactured until suitable changes are made, they are reported to the FDA and have obtained verification.

Chiang said the 23 products should be taken off shelves before April 15 at midnight.

Linkou Chang Gung Memorial Hospital Division of Clinical Toxicology (�L�f�������|�{�ɬr����) Director Yen Tsung-hai (�C�v��) pointed out that since excipients is a field that requires deep expertise and understanding, the FDA should enlist help from specialists to overlook drug management regarding food-grade and pharmaceutical-grade ingredients. Stomach Powders Found with No Medical Potency

The FDA found that New Taipei City’s Johnson Chemical Pharmaceutical Works Co. (�j�ͤƾǻs��) Saporo A Granule (�n�O�֦w�z�G��) and Jen Chang Sheng’s Jian Stomach Powder (�����Ͱ��G��) were using uncertified levels of chemicals and low levels of magnesium oxide, which is the deciding factor of the medicine’s potency, causing suspicion regarding its drug efficiency. Chen Hui-fang (���f��), from the Division of Research and Analysis at the FDA, stated both Johnson and Jen Chang Sheng’s products all use ingredients that exceed regulation levels, which makes the stomach medicine harmful to the body under long-term medication.