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Star Health Report
Recently China has identified a contaminant in batches of blood-thinner heparin supplied by a U.S.-owned plant in China for export to the United States that has been linked to serious reactions and deaths.
China's State Food and Drug Administration (SFDA) said that the contaminant was "basically the same" as that found by U.S. health regulators in batches of Baxter International Inc's blood-thinner heparin.
The contaminant is the cause of up to 19 deaths and hundreds of serious breathing problems and other reactions reported in the United States.
China's drug watchdog confirmed the contaminant had been found in batches of heparin supplied by a China-U.S. joint venture plant in Changzhou to Baxter.
The plant was "one link in a long production chain of heparin", Xinhua news agency quoted the SDFA as saying in a report.
The FDA has received 785 reports of heparin infections, including 19 deaths in patients treated with some brand of heparin — news agency Reuters reported. Baxter has said only four deaths may be related to its heparin and there is not enough information to say the drug was the cause.
Following the incidence, supplies of the bloodthinning drug heparin are being recalled in France, Italy and Denmark because they are contaminated or suspected of being contaminated, although there have been no reports of patients being harmed by the medicine in those countries, the Wall Street Journal said.
The European Medicines Agency presumes the contaminant in all three countries is the same as the one identified in recalled U.S. batches of the drug, a chemical called over-sulfated chondroitin sulfate, the article on the Journal's Web
site said.
Moreover, the active ingredient used to make heparin is being recalled in Italy and Denmark because it is contaminated, the agency spokesman said. The chemical was made by an Italian company, Opocrin SpA, which used raw ingredients sourced in China, the agency spokesman said.
Batches of the drug have recently been recalled in Germany and the United States, where some patients taking the drug suffered allergic reactions. In both the United States and Germany, the contamination surfaced in supplies made from ingredients bought in China, the article said.
The U.S. FDA spokesperson Karen Riley said that the agency's inspection team has completed their inspection of the China facility and a number of potentially objectionable conditions were identified relating to the firm’s manufacturing process.
China's State Food and Drug Administration (SFDA) said that while it does enforce its own strict controls on the chemicals used in pharmaceuticals, safeguarding the legality, quality and safety of active pharmaceutical ingredient (API) is ultimately the responsibility of the importing country.
There is huge demand of the Chinese APIs in the global pharmaceutical market including Asia, Europe and America due to their competitive low cost. But countries like ours, patients are paying the toll of these poor quality raw materials, where there is lack of high performance laboratory to evaluate the quality of the raw materials.
The concern has raised safety scare among the conscious people including healthcare professionals. They urged the concerned authority to increase their scrutiny about the total manufacturing process producing life-saving drugs.