The safety scare caused by Baxter's blood-thinning drug, heparin, in the US is fast spreading to Europe and Japan necessitating recall of the drug from these markets. Production of the drug in multi-dose vials was suspended in February last after heparin was found to have linked to four deaths and 350 reports of severe allergic reactions in the US. Initial investigations have found that some of the active pharmaceutical ingredients (APIs) for heparin were sourced from the Changzhou SPL plant in China, which the US FDA had never inspected. Baxter has already pulled back the product from the market. Later, German manufacturer Rotexmedica has withdrawn its heparin product from the market after 80 severe allergic reactions were reported by patients who were given the drug since 14 February. Although the product was being manufactured in Germany, the sourcing of the APIs for the drug has been associated with two Chinese suppliers. France, Italy and Denmark are other countries which have withdrawn heparin from their markets. Three pharmaceutical firms based in Japan have also recalled their heparin products from the market last month due to a possible association with Chinese made APIs.
The heparin controversy has raised two major issues the global pharmaceutical industry is facing today. First is the growing disregard of international pharmaceutical companies to check quality while using APIs and other ingredients sourced from overseas destinations. Secondly, serious lapses on the part of regulatory authorities of developed countries in inspecting overseas facilities supplying APIs. The US FDA and the European Agency for the Evaluation of Medicinal Products do not regularly inspect all foreign facilities manufacturing and supplying APIs. In fact, many of these facilities have never been inspected, although 75 per cent of all APIs used by EU and US drug manufacturers are imported, mainly from India and China. The findings in the report of the Government Accountability Office of the US last November have highlighted this serious deficiency of the US FDA. China's 714 drug producing establishments made up 22% of all foreign facilities eligible for FDA inspection during 2007. But the agency conducted only 13 inspections in China that year, representing just 4 per cent of all inspections outside the US. India had the second highest number of eligible establishments - 410 or 12.65 per cent of the total - and was subjected to 65 inspections in 2007, 22 per cent of that total.
Globalization of supply chain in pharmaceutical industry is going to be a tough challenge for ensuring quality of pharmaceuticals in the years to come. And Indian formulation producers also import a large number of APIs and other ingredients from China just because they are cheaper. It was to ensure the quality of imported drug materials, Indian government had made registration of all imports of drugs and pharmaceuticals into the country compulsory from April 1, 2003. Absence of a registration system has been resulting in import of large quantities of substandard drug materials into the country for some years. The registration system was expected to bring an end to the inflow of poor quality drug materials through a scrutiny of import applications and inspection of manufacturing sites of exporters. For one year since 2003, there has been a decline in the import of substandard drugs into the country but it is hardly working now. There is no quality assurance of APIs being imported into the country today. This is largely on account of the failure of the office of DCGI to carry out inspection of overseas manufacturing sites especially originating from China. The heparin controversy is a clear warning signal to Indian drug authorities. DCGI has to be serious in this matter and enforce import registration rules by commencing inspection of all manufacturing sites which supply APIs and other ingredients to Indian pharmaceutical industry without any further delay.