In 2008, use of contaminated Heparin led to the deaths of over 80 patients and several cases of adverse reactions in the US. As a result, the US Food and Drug Administration (FDA) and companies supplying heparin announced a major recall of the anticoagulant, which is used by approximately 12 million Americans each year. The source of the contamination was found to be the use of over-sulfated chondroitin sulfate (OSCS) in the active ingredient, made in China. OSCS was introduced during the early points in the product’s supply chain as it is chemically similar to the active ingredient in heparin.

This heparin contamination issue is not a one-off case. There were many such cases reported in the past, with regulatory agencies issuing frequent safety alerts or product recalls.

Such incidents have forced regulatory agencies and pharmaceutical manufacturers to look into the safety of the medical supply chain and take steps to prevent such contaminated substances from entering the market. It is in this regard that the European Union (EU) has called for Marketing Authorization Holders (MAH) to have a mandatory Qualified Person (QP) declaration for the release of all medicinal products in the EU/ European Economic Area (EEA), which is expected to be compulsory by July, 2013. This declaration will imply that the product has been sourced, produced and controlled in accordance with the requirements of marketing authorization or other relevant regulatory standards.