Pharmaceutical News
NHI Supervision Alliance suggests a thorough check on all instruction drugs

Reported by Liao Pei-Yu from Taipei

There are 72 drug companies in Taiwan producing products containing calcium carbonate or magnesium carbonate.  The TFDA revealed that 46 drug products from 32 of those drug companies are considered inferior.  The general public are no longer sure about which drug is safe.  Considering the fact that many of the drug companies involved in this scandal are well-known manufacturers or even listed companies, civil groups urged the TFDA to tighten up control and carry out a thorough check on all instruction drugs. 

Teng Xi-Hua, the Spokesperson of the NHI Supervision Alliance, expressed that using inadequate raw materials in drugs is obviously not an isolated case, because too many drug companies have been involved in it.  It shows that this malpractice is quite established.  Drug companies’ ability in performing self-management is now questionable.  The authority should not turn a blind eye to it. 

Lee Min-Chin, a section chief of the TFDA, said frankly that calcium carbonate and magnesium carbonate are comparatively safe materials; therefore, the TFDA had never carried out inspections on them.  In the future, the control will be tightened up, said Lee.  The TFDA is now trying to clarify what other materials can be used in both drugs and foods, and will subject them to inspection. 

However, Teng Xi-Hua said that the TFDA’s site inspection is notoriously slack.  The TFDA always tries to catch up with inspections under the pressure of public opinions after every food or drug safety scandal.  As so many drug companies are involved in this scandal of antacids, it makes people wonder about the safety of other drugs.  The TFDA should carry out a thorough check on all instruction drugs in order to safeguard the public’s health. 

Teng Xi-Hua expressed that two years ago, there was an incident concerning drug companies’ changes of excipients without notifying the authority.  Those drug companies got away with just a small fine. Though the PIC/S GMP system was introduced into Taiwan in 2012, there must be a loophole in the certification process to allow such a scandal to happen. 

Prof. Huang Wen-Foung of the Institute of Hospital and Health Care Administration of the NYMU expressed that there are certainly problems in the administrative procedures in those drug companies.  If they breach the GMP Guidelines from the beginning, the final products will of course be inferior.  

However, Prof. Huang said that the drug manufacturing and control process cannot be perfect from the start.  It will evolve into a stringent system.  The industry and the official authorities should learn from their mistakes; and the society should not totally negate the industry’s efforts for minor mistakes.  

【2015-04-19/ China Times】