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Thorough GMP Auditing And Harmful Active Pharmaceutical Ingredients

27th December, 2009 - Posted by health news - No Comments

We are affected by medicines because of the Active Pharmaceutical Ingredients or API which is in them. Some companies have a patent which means the quality of the API is maintained however off-patent drugs means that this is not always the case. 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 APIs come from a non-listed source and as such, they have not been through GMP auditing and could actually be toxic to humans. 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. With so many factors to the production of the drugs, it is hard to audit every step of the process.

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.

With so many drugs entering the EU market, there are unknown numbers of health problems that could occur. If the APIs which have not been audited do contain toxic materials, these could end up killing patients. Reactions with other medication or accidental overdose are just two of the scenarios that might occur.

Indian and Chinese manufacturers have been found to produce an increasing number of substandard Active Pharmaceutical ingredients over the past ten years as shown in the results of GMP Auditing. Whilst inspecting 160 manufacturers in these two countries the European Directorate for the Quality of Medicines and healthcare suspended or withdrew 50 GMP certificates. And the EDQM predicts that these figures will continue to grow over the next decade.

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. One thing is for sure though; no company should release potentially toxic medicines onto the general public just in the search to cut costs and make bigger profits.