FDA site inspections : Another "overhaul"

We read often that economies are in crisis, and the system needs an overhaul. One organization that constantly seeks to overhaul is FDA.

Some of you might have heard about lead contamination (and toy recall) connected to Chinese manufacturers, this time it is for drug contamination. Heparin, a popular blood thinner was associated with 81 deaths and source of contamination was traced to a Chinese manufacturing facility. Now FDA needs 70 million USD per year to carry out inspections 2-3 years once of the 700 plus manufacturing units in China alone - which is expected to cover only "partially".

The point is not about Chinese manufacturing, but it is about increasing pressure to balance economics, globalisation and regulations. Currently FDA only inspects foreign facilities only during approval of the new drug, that leaves out another 20-30 years before the next inspection !!! The pressure on federal organizations multiplies with lax local regulations, I am sure the situation with Chinese manufacturing will not be different from other developing nations - it is only a matter of time before the whole cascade starts to unravel.

Bottom line : If developing nations have to even start to imagine about becoming clinical research hubs, the primary requirement is regulatory framework. It is NOT investment and definitely not availability of skilled and economical manpower.

FDA will have a permanent office in China from October 2008 and the Drug Information Agency (DIA) has announced the recent opening of its first office in India, in Mumbai, along with the creation of a Provisional Advisory Council of India (ACI).