China bans medicines formulated in toxic capsules
pharmafile | April 17, 2012 | News story | Manufacturing and Production |Â Â China, SFDA, impurities, manufacturingÂ
China’s State Food and Drug Administration (SFDA) has banned the sale of 13 medicines thought to be manufactured using contaminated gelatine capsules which could put patients’ health at risk.
The capsules used in the products are said to have been made using industrial rather than pharmaceutical-grade gelatin and as a result contain excessive levels of chromium, according to a report from the state-run Xinhua news agency. The products include 11 traditional Chinese medicines and two antibiotics.
A total of 22 people are reported to have been detained for questioning by police in connection with the incident.
China is in the midst of a major clampdown on medicine quality in the wake of the introduction of new rules on Good Manufacturing Practice (GMP), which were introduced last year and are expected to be fully implemented for all companies serving the Chinese medicines market by the end of 2015.
The new GMP rules place the onus on pharma manufacturers to ensure that they purchase raw materials from reliable suppliers with current manufacturing licenses.
The capsules are reported to have been made at four factories in the Zhejiang region of China from gelatin derived from scrap leather. Chromium is used in the tanning process for leather, and repeated exposure to excess levels is linked to the development of cancer.
Xinhua notes that 11 of the detained suspects work for capsule manufacturers based in Xinchang, a pharmaceutical hub within Zhejiang province, and that 43 other companies are being investigated. The gelatin used in the capsules is thought to have been supplied by companies in Hebei and Jiangxi provinces.
Metal impurities are a hot topic for the pharmaceutical industry at present, in the wake of the publication of a draft International Conference on Harmonisation guideline (ICH Q3D) on the topic, as well as on proposed revisions to the US Pharmacopeial Convention (USP) general chapters on elemental impurity limits and procedures.
Phil Taylor
Related Content
CARBOGEN AMCIS manufacturing license advances services in China
Swiss pharma manufacturing company, CARBOGEN AMCIS, has announced that its facility in Shanghai, China, has …
Meribel Pharma Solutions launches to take pharma services to new heights
Meribel Pharma Solutions, a new mid-sized contract development and manufacturing organisation (CDMO), has officially launched …
Bend Bioscience adds commercial spray drying facility to Georgia site
Bend Bioscience has announced the addition of a commercial-scale spray dryer and a Gerteis dry …
