China watchdog responds to heparin scare; AZ now affected

By Kirsty Barnes

- Last updated on GMT

Related tags: Heparin, Pharmacology

China's drug regulatory authority is finally responding to curb its
damaged reputation by urging its local authorities to take a more
proactive role in stemming what is fast becoming a global heparin
contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality. The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards. In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market. Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware". The agency said last month that while it does enforce its own strict controls on the chemicals used in pharmaceuticals, "safeguarding the legality, quality and safety of active pharmaceutical ingredients (APIs)" is ultimately the responsibility of the importing country. According to the SFDA, companies that manufacture APIs in China must be registered and certified as pharmaceutical companies by the watchdog after it carries out an inspection of the facility. It is this authority that importing firms and the regulatory agencies of importing countries should look for before accepting any product from a Chinese company. In addition, any importing country should also still conduct their own stringent quality control tests on APIs, excipients and finished drugs, the agency said at the time. While the watchdog's latest actions by no mean indicate it has changed its opinion on the matter of where the final responsibility for quality control lies, it does signal that it has recognised it still has a large role to play. The agency's proactivity is overdue, considering the fact that China's already somewhat dubious pharma manufacturing reputation has been taking a beating for the past two months, at a time when the country's pharmaceutical industry has been actively trying to increase its international dealings. What started as an isolated incident of contamination of certain lots of heparin sold by Baxter Healthcare in the US, of which the API was traced back to a supplier in China, has now spread to several countries across the globe, with multiple Chinese API suppliers also now implicated. Hundreds of patients have reported severe adverse events and there are 19 deaths linked to the health scare. It has since been revealed by a US Food and Drug Administration (FDA) investigation that the drug lots in question were contaminated with a substance called oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved for use in medicine. So far, the US, Germany, France, Italy, Denmark, Switzerland and Japan have all pulled heparin products from the market due to the presence of contamination or as a precautionary measure after API links to China were made. Australia and perhaps the UK are looking likely to be the next countries to follow suit. Australia's Therapeutic Goods Administration (TGA) recently issued a statement on its website claiming that it had discovered contamination in samples of heparin distributed by UK-based drug giant AstraZeneca. Although there have been no increase in the number of adverse events reported from use of the drug, the regulator said that "it is unclear whether the contamination is related to single batches or affects heparin products more generally,'' as testing is still underway. AstraZeneca has since confirmed that its heparin API was sourced form China and it is in discussions with the TGA to recall the affected product as soon as possible. The firm also indicated that it is now evaluating its China supply chain.

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