China drug safety crackdown continues

By Kirsty Barnes

- Last updated on GMT

Related tags: Drug safety, Pharmacology, European union, Food and drug administration, China

China has announced a crackdown on its drug safety regulations in
an attempt to remedy its international reputation as a producer of
unsafe and counterfeit drugs.

The move comes only a week after the former director of the country's State Food and Drug Administration (SFDA) was sentenced to death on charges of corruption. As part of an apparent new hard line approach, China's top administrative body, the State Council has announced a series of regulatory reforms, vowing to place new controls on drug (and food) imports and exports by 2010 and to increase the proportion of such products that are subject to random inspections to 80 per cent, up from the current figure of 30 per cent. As well as keeping a closer eye on the manufacturing facilities where legitimate drugs are manufactured, the government body has also indicated its intention to crack down on the production and sale of counterfeit drugs and medical devices. For years China has been suffering from a dubious reputation in the pharmaceutical industry. In one high profile case in May 2006, nine people died in China after being injected with a concoction of Armillarisni A that contained a fake and toxic ingredient. In Panama last year, more than 40 people died after taking cough syrup, antihistamine tablets, and calamine lotion which contained glycerine that was contaminated with diethylene glycol (DEG), a poison used in antifreeze and as a solvent. The glycerin was originally sourced from China. Meanwhile, China is also a source of much of the world's counterfeit​ drugs - another acute danger to public safety, not to mention the impact on pharma industry revenues. In addition to the death sentence dished out last week and a simultaneous pledge by the SFDA​ that it will send 90 officials to carry out drug safety inspections in 15 provinces across the country over the next two weeks, this latest regulatory announcement provides further indication that China is now serious about reform and is at least attempting to reverse its damaged reputation. The news may also signal a light at the end of the tunnel for the beleaguered drug regulatory agencies of the West, who are now swamped by an ever-increasing number of drug imports from developing nations such as India and China. Last year, two trade associations of the world's two largest pharma economies - Europe and the US - took the unusual step of banding together at the CPhI in Paris to condemn their 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. Despite having strict rules in place to ensure that drug APIs meet current good manufacturing practices (cGMP), the US Food & Drug Administration (FDA) and the European Medicines Agency (EMEA) do not regularly inspect all foreign facilities manufacturing APIs serving them, claim EFCG and SOCMA​. This is worrying, considering that around 80 per cent of the APIs used by US manufacturers to make prescription drugs are now made in foreign facilities. Also of concern is the fact that even though 40 per cent of all prescription drugs sold in the US are now also manufactured abroad, a citizen's petition filed with the FDA by SOCMA last year indicated that while drug manufacturing plants in the US are supposed to be inspected regularly (every two years), FDA-approved facilities in China and India are generally only being inspected at intervals of five years or longer. Furthermore, 90 per cent of the inspections carried out by the FDA are pre-approval inspections, while only 10 per cent are for cGMP compliance purposes, according to Joe Acker, President of SOCMA. He also expressed major concern over the fact that the FDA does nothing to inspect the API manufacturers for over the counter (OTC) medicines such as paracetamol. "This is alarming when you consider the fact that over 50 per cent of the API for OTC medicines in the US comes from India and China,"​ Acker said. Meanwhile, Guy Villax, chairman of EFCG's Pharmaceuticals Business Committee, said that in the European Union the situation is even more alarming. There, the EU is unable to account for the number of manufacturing facilities importing into the EU, without consideration to the number of inspections performed. "The EU has no foreign inspection service or budget and don't even know who is making the APIs that are coming into Europe,"​ said Villax. "In the instances where a non-compliant producer is identified importing into a European particular country, there is no common EU procedure for dealing with these offenders and no uniform customs control throughout the Union so they are generally left free to slip through the net and continue operating in other parts of Europe."

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