Several people have been arrested and 13 products recalled over high levels of chromium
It has been reported in the China Daily and on the The State Food and Drug Administration\'s (SFDA\'s) website that contaminated gelatin capsules containing excessive levels of a toxic material (chromium) have been used in branded pharmaceuticals made in China.
Local police will investigate 43 capsule manufacturing companies in Xinchang and suspend operations for those found to be operating outside the law, the spokesman said. Several individuals had been arrested for allegedly producing and selling pharmaceutical capsules containing excessive levels of chromium.
The SFDA says it has ordered a recall of 13 products produced at nine plants known to have used the contaminated gelatin-based capsules, including two antibiotics, according to the state-run Xinhua news agency.
The fake edible gelatin raw materials were made from waste leather leftovers supposed to be used in leather clothing. The leftovers were treated industrial chemicals that lead to the excessive levels of chromium. Once the gelatin is extracted from the leather it is then sold to capsule manufacturers that then sold the capsules to pharmaceutical companies to use to make medicines.
‘Gelatin used in pharmaceuticals should follow a strict production procedure, with tight controls on collection of material in slaughterhouses, treatment and processing steps, says Phil Taylor, a writer for the International Pharmaceutical Excipients Council.
Protracted exposure to excess chromium is linked to the development of cancer, and investigations by the Chinese authorities indicate that the recalled capsules contained up to 90 times the permissible levels of the contaminant (2mg/kg), said Taylor
This is a blow to the rest of pharma manufacturing sector in China. The country has been striving to boost quality levels in its huge and fragmented pharmaceutical sector, for example by drawing up new regulations on Good Manufacturing Practice (GMP) last year which will have to be followed by all companies serving the domestic market by 2015.
The SFDA issued an emergency notice, calling for suspended sales and consumption of a list of drugs that may have been packed into the contaminated capsules. It has instructed local bureaus to monitor the drugs specified in the notice.
The Chinese Pharmacopoeia sets clear standards for capsule manufacturers and requires drug makers to purchase capsules only from licensed manufacturers, the SFDA notice said.
The notice said drug manufacturers face legal consequences if inspection results indicate that they have failed to meet government standards.