Thorough GMP Auditing And Toxic Active Pharmaceutical Ingredients
The part of a drug that makes us better is the Active Pharmaceutical Ingredients or API. The growth of off-patent medicines means that a patent does not always protect the integrity of the API. Some companies have turned to using falsifies substandard APIs in their drugs they manufacture so that they can lower production costs and maintain profits.
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. auditing every stage of production from these countries to the finished product is difficult with so many countries involved.
it has been estimated by The European Fine Chemical group that 80% of medicines on the British healthcare system have APIs which were manufactured in India or China, whilst the European Directorate for the Quality of Medicines and Healthcare (EDQM) estimates that 20-30% of off-patent medicines in the EU have falsified APIs in them.
This is a huge number of medicines and the consequences could be fatal. If the APIs which have not been audited do contain toxic materials, these could end up killing patients. There is a high risk of accidental overdose and serious reactions between two different APIs when toxic ingredients mix with safe prescription drugs.
GMP Auditing over the past 10 years has seen rising numbers of substandard Active Pharmaceutical Ingredients discovered in Indian and Chinese manufacture bases. 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.
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