Reported by Chen Yu-Chin from Taipei
Inferior drugs are sold in the market, threatening the public’s health. According to the TFDA, excipients used in drugs only need to comply with the regulations in the Chinese Pharmacopoeia. Prof. Huang Weng-Foung of the Institute of Health and Welfare Policy of NYMU pointed out that the Chinese Pharmacopoeia is not able to regulate every excipient. He suggested that the government should request all excipients to meet the standard for food materials.
The US National Formulary defines excipients as any ingredients purposefully added to a drug in addition to its active ingredients. Therefore, excipients account for higher contents in a drug than the active ingredients. There have been mortality cases which are associated with contaminated excipients. In most countries, excipients, by law, must be produced by GMP manufacturers.
The TFDA stressed that for the raw materials of drugs, there are no such things as “industrial grade” or “food grade”. Drugs are chemicals. The regulations in the Chinese Pharmacopoeia are stricter than the standards applied to foods. However, Prof. Huang expressed that the TFDA ignores the fact that the properties of a chemical could change just by modifying one of the chemical’s sequences. Therefore, there are numerous excipients outside the scope of the Chinese Pharmacopoeia.
Prof. Huang pointed out that the authorities in the US, Japan and the Europe are very concerned about the management of excipients. So far, it may be not possible to control and manage every excipient. What the government can do is to request manufacturers to use excipients of “Food Grade”.
The TFDA made an announcement on May 27, 2014, requesting that all new drugs should label their excipients in the package inserts. This requirement will extend to all drugs by the end of this year. Teng Xi-Hua, the spokesperson of the NHI Supervision Alliance, accused the TFDA for its slackness as it takes 6 years to bring the requirement of labelling excipients to full implementation.
Chi Ro-Fong of the TFDA pointed out that the TFDA will consider revising the Guidelines on Drug Review and Approval and request manufacturers to submit excipients for review.
Chiang Yu-Mei, Director of the TFDA, expressed that the TFDA has requested the five manufacturers involved in inferior quality of excipients to temporarily remove their products from shelves as a preventive measure. The TFDA will make the final decision when the assessment report is ready. In situations where inferior products are still circulating despite the TFDA’s decision of product withdrawal, a fine of NTD200K - 5 million will be imposed on the drug company.
【2015-04-04/ United Daily】