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Autor: tkwriter
~ 18/02/10
Active Pharmaceutical Ingredients or APIs are the chemicals in a pill or liquid medicine that works in our body to make us better. Patents are supposed to uphold the integrity of these APIs however a recent development in the pharmaceutical world means that there are thousands of off-patent drugs used in countries around the world. The thousands of drugs which are off-patent means that drug manufacturers have to find ways to lower their costs in order to stay profitable, and using falsified APIs is one way that companies are doing this.
These falsified APUIs could contain toxic chemicals because they have not been through GMP auditing. The supply chain which brings APIs into the EU is so long that it is hard to inspect whether the API is falsified or not. Outsourcing their work to India and China is another way that some companies have saved money due to cheaper labour. However, this long supply chain makes it incredibly difficult to inspect every aspect of production.
The European Fine Chemical group has estimated that 80% of medicines which are used in Britain contain APIs from India and China and the European Directorate for the Quality of Medicines and Healthcare (EDQM) has stated that through the results of its audits, ads much as 20-30% of all off-patent medicines in the EU could contain falsified APIs.
These percentages add up to a huge number of drugs entering the EU market and the results could be hundreds or thousands of health issues. Patients could end up dead if they are given drugs containing toxic APIs. There is a high risk of accidental overdose and serious reactions between two different APIs when toxic ingredients mix with safe prescription drugs.
Over the past 10 years the results of GMP Auditing has uncovered a rise in the number of substandard APIs coming from Indian and Chinese manufacturers. The European Directorate for the Quality of Medicines and Healthcare suspended or withdrew 50 GMP certificates for these API manufacturers during the inspection of 160 plants. These figures have been estimated to grow even further over the next few years.
GMP auditing is the only way to catch the producers of falsified APIs and it is one of the most important aspects of the pharmaceutical industry. However one thing is for sure, it is morally abhorrent to release deadly APIs onto the market all in the name of bigger profits.
