Medicine in­ves­ti­ga­tion en­ters stage 2: Food and Drug Ad­min­is­tra­tion


The Food and Drug Ad­min­is­tra­tion (FDA, ) 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’ ( ) Taisho Gran­ule ( ), Grape King’s ( ) Hi­weikean Gran­ules Grape ( ) and Min Tong’s ( ) Couweiton Gran­ules (

) are among the fake medicine an­nounced by the FDA.

The FDA also re­ported that Yuncheng Chem­i­cal ( ) and I Hs­ing Trade Com­pany ( ) 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 ( ) Direc­tor Yen Tsung-hai ( ) 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. ( ) Sa­poro A Gran­ule ( ) and Jen Chang Sheng's Jian Stom­ach Pow­der ( ) 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.

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