Heparin Sodium Price Hike

Of late we have seen prices of injection Heparin Sodium mainly used in dialysis treatment has shot through the roof. To help us understand some of the reasons for the increase we need to go back in history.

In 1986 “Bovine Spongiform Encephalopathy” or Mad Cow Disease was first realized in the UK and subsequently traced to cattle food imported from Europe. Cattle food was contaminated with infected cattle parts which were added as a source of protein for the cattle. Humans were infected with the human variant of the disease known as the Creutzfeldt-Jacob Disease when they consume the infected beef.

By 2004, a total of 157 patients in the UK were confirmed to have died from the disease which also affected UK and Europe’s cattle and its related industries. In 2005, 5 cases of the dreaded disease were discovered in the US which also saw the decline of the cattle and its related industries there. There were real concerns then that contaminated UK, European and US cattle by-products may be infected with the said disease.

A search for a new source for raw Heparin Sodium has lead European and US suppliers to China in the form of Porcine Heparin Sodium. But between November 2007 and February 2008, hundreds of patients in Europe and US experienced allergic reactions to the Heparin Sodium and in the US a total 81 suspected related deaths were reported. Many other countries were also affected when they imported the alleged Heparin Sodium from the US and European suppliers.

The Food and Drug Authority (FDA) of the US investigations recorded contamination of “over-sulphated chondroitin” to be the cause. This contamination is alleged to have occurred due to the drop in supply of raw Porcine Heparin Sodium due to the “blue ear” disease which affected the Chinese pigs then. It is alleged that due to either the urge to make a quick buck or make up for slack in supply, the supply were adulterated, intentionally or unintentionally.

This incidence resulted in FDA and Health Authorities worldwide to carryout additional tests in the manufacturing of Heparin Sodium.

After corrective measures in placed in 2009 and due to increase worldwide demand, China’s export of raw Heparin Sodium rose 155% year on year. This saw the increase of the average price to USD4,354/kg, an increase of 100% compared with 2008.

This sharp increased saw a tremendous pressure exerted on suppliers of Heparin Sodium from non “Bovine Spongiform Encephalopathy” infected areas to meet the sudden increased in demand, this resulted in an uncontrollable spiral skywards prices too.

Due to religious sensitivity, the Heparin Sodium available in Malaysia is mainly from the Bovine source. However contamination of “over-sulphated chondroitin” does not affect Bovine Heparin Sodium. But as a precaution and as a regulatory requirement, the Malaysian Health Authorities (KKM) has made it compulsory for testing of “over-sulphated chondritin sulphate” for the manufacturing of injection Bovine Heparin Sodium.

Due to the high demand and shortage of supply of raw Heparin Sodium, the incidences of contamination and caution of one source and increased demand on another, and regulatory requirement to add additional tests for manufacturing have all contributed to the spiral increase of manufacturing cost of injection Heparin Sodium.

Be forewarned that prices of injection Heparin Sodium will continue to rise with the demand outstretched supply, until and unless new and cheaper source is identified.