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China enhances drug safety measures under worldís gaze

China continues to enhance its drug safety regulations in order to change its poor international reputation as a source of dangerous and counterfeit drugs

China continues to enhance its drug safety regulations in order to change its poor international reputation as a source of dangerous and counterfeit drugs.

The move follows the sentencing to death of the former director of the country's State Food and Drug Administration (SFDA), Zheng Xiaoyu, on charges of corruption.

China's State Council has instituted a number of regulatory reforms and has promised to enforce new controls on drug imports and exports by 2010, while subjecting the proportion of products inspected to 80 per cent from the present figure of 30 per cent.

The State Council has also revealed its intention to crack down on the production and sale of counterfeit drugs and medical devices. In May 2006, nine people died after being injected with a concoction of Armillarisni A, which contained a counterfeit and toxic ingredient.

The effects of Chinese counterfeiting have affected other countries. In 2006 in Panama, more than 40 people died after taking cough syrup, antihistamine tablets and calamine lotion which contained glycerine contaminated with diethylene glycol (DEG), a solvent. The glycerine came from China.

The news will no doubt offer the drug regulatory agencies of the West a glimmer of hope. Many have been deluged with increasing numbers of drug imports from developing nations such as India and China.

In 2006, the trade associations of the EU and the US pharmaceutical industries joined forces at the CPhI in Paris to condemn domestic regulatory authorities for poor regulation of foreign active pharmaceutical ingredient (API) manufacturers. The Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) are demanding that regulators increase their inspections of such foreign facilities. The FDA and the European Medicines Agency (EMEA) do not regularly inspect all foreign facilities manufacturing APIs serving them, claim EFCG and SOCMA.

Both groups say that around 80 per cent of the APIs used by US manufacturers to make prescription drugs are now made in foreign facilities. FDA-approved facilities in China and India are only being inspected at intervals of five years or more. Also, 90 per cent of FDA inspections are pre-approval in nature, while only 10 per cent are for cGMP (Good Manufacturing Practice) compliance purposes, according to SOCMA.

The EFCG's Pharmaceuticals Business Committee said that the EU was unable to account for the number of manufacturing facilities importing into the EU, without taking into account the number of inspections done.

14th June 2007

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