Pharmabiz
 

China launches drug safety technology campaign

Our Bureau, MumbaiThursday, November 9, 2006, 08:00 Hrs  [IST]

China has launched a campaign to promote the use of technology to guarantee the safety of pharmaceuticals and patients. The campaign, launched by the Ministry of Science and Technology (MOST), the State Administration of Traditional Chinese Medicine (SATCM) and the SFDA, is aimed to provide full technological support for every step of a drug's journey from laboratory to patient. The campaign is aimed to solve ten major technological problems concerning drug safety over the next five to ten years. Further, China will set up three to five authorized and standard drug safety research and review centers to monitor and regulate safety of drugs. Further, the campaign also hopes to improve innovation in drugs manufacturing and raise the competitiveness of Chinese medicine in the mainstream international market. "The number of drug-related accidents has risen in recent years and the cases involving the Qiqihar No. 2 Pharmaceutical and the Xinfu drugs has attracted the attention and concern of the central government," said Shao Mingli, head of the State Food and Drug Administration (SFDA). It may be noted China is in the process of framing legislations to ensure safety of prescription of medicines. The regulations for the Classification Management of Prescription and Non-prescription Drugs has been included in 2006 legislation plan by the State Council. After serious study and several amendments, the drafting of the Regulation has been basically achieved and the regulations for the Classification Management of Prescription and Non-prescription Drugs (draft for comments) are now soliciting public opinions. Advices or opinions from the industry and public were to be submitted to the Division of Regulations of the Department of Policy & Regulations of the State Food and Drug Administration before November 5, 2006. Further, to crack down on making and selling counterfeit or substandard drugs, guarantee drug safety for the public, the SFDA issued Work Scheme for Rectifying and Standardizing Drug Research, Production and Circulation Order on September 8, 2006 according to the requirements of Scheme for the Campaign of Rectifying and Standardizing Drug Market Order issued by the General Office of the State Council. The Work Scheme specified the working emphases, working measures, implementation and working requirements of the initiative. Due to repeated incidences of sub-standard drugs causing killing of many people, China is in the process of ensuring legislations to protect the safety of drugs. SFDA, China's national drug regulator, has revoked the license of the maker of the Xinfu drug, an antibiotic blamed for at least six deaths and dozens of illnesses. Patients who took the antibiotic developed severe adverse reactions, such as chest, kidney or stomach pains, vomiting and anaphylactic shock. Earlier this year, 11 people were killed after injecting a drugmade by the Qiqihar No. 2 Pharmaceutical Co. Ltd. in the northeastern province of Heilongjiang.

 
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