Such campaigns have been run before, and face stiff opposition from firms that employ millions of people; the culture of a cheap copy runs deep. However a recent scandal has been widely publicised. Almost 1,000 people were given counterfeit Avastin and Shanghai Number One People’s Hospital was forced to compensate 61 people for adverse reactions. The hospitals were not only using false Avastin – only just officially launched by Shanghai Roche Pharma – but were also using it for an indication not yet approved in China, treatment of macular degeneration.

New standards for manufacturing

The Chinese FDA is circulating a draft regulation that would improve traceability and expand supply chain auditing for active pharmaceutical ingredients (APIs), excipients and packaging, reports International Pharmaceutical Quality. The draft shows intent to align with the drug master file system in Europe and the US.

The regulation, if implemented, will apply to marketed drug products registered in China; so far it does not address exported APIs or excipients manufactured in China. However it does require manufacturers to have written agreements with suppliers and provides for drug manufacturer audits of the makers of API intermediates and starting materials.

1 October 2010 saw the publication of China’s latest Pharmacopeia. The updated edition introduces improvements on around 70% of existing formulations. “That means new drugs will face stricter standards to enter the market... and low-quality products will be washed out”, said a spokesman.

It remains to be seen how well the Chinese authorities enforce the new rules and standards.

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