Pharmaceutical News
Inferior drugs damage the credibility of GMP certification

Reported by Chen Yu-Hsin from Taipei

The TFDA found that 23 drugs manufactured by 13 drug companies in Taiwan contain active ingredients not up to the standard for drugs.  Those 23 stomachics were found containing magnesium carbonate or calcium carbonate graded for foods rather than for drugs.  It is particularly ironic that the TFDA discovered this malpractice 5 years after its promotion of the PIC/S GMP certification. 

On the 8th, the TFDA started an inspection of all stomachics manufactured in Taiwan, and found that 13 out of the total 27 drug companies under inspection failed to comply with the PIC/S GMP regulations.  23 products are actually inferior drugs.  The TFDA said that the drug companies are to be blamed.  However, the NHI Supervision Alliance criticized the TFDA for negligence. 

Lee Min-Chin, a section chief of the TFDA, expressed that the drug companies’ management is too slack.  He also pointed out that there is misunderstanding of the quality of raw materials for the manufacturing of drugs.  Some drug companies wrongly believe that materials graded for foods can be used for stomachics.  In fact, the Pharmaceutical Affairs Law states clearly that all raw materials of drugs must be certificated.   The drug companies involved clearly breach Article 21 of the Pharmaceutical Affairs Law and GMP regulations. 

Lee Min-Chin pointed out that the TFDA will not revoke the GMP certificate simply for the mishap of using raw materials graded for foods.  Lien Hung-Rong, a TFDA official, pointed out that the raw materials graded for foods will not do human body any harm.  The TFDA said that those 13 drug companies will be subject to a fine of up to NT$300,000.  The TFDA has requested all 23 drug products to be removed from shelves before 12:00 a.m. of the 16th, and all products to be withdrawn by the manufacturers before the 14th of May.

【2015-04-12 / United Daily News】