Thorough GMP Auditing And Dangerous APIs
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. 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. With so many factors to the production of the drugs, it is hard to audit every step of the process.
It has been estimated that 20-30% of all off-patent drugs in Europe contain falsified APIs and in Britain, 80% of our medicines contain APIs which were produced in India or China.
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. Toxic APIs could end up having deathly consequences in some patients. Reactions with other medication or accidental overdose are just two of the scenarios that might occur.
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. This is a huge percentage and the EDQM predicts that these figures will continue to grow.
The only way that the manufacturers of falsified APIs can be found is through GMP Auditing, which is extremely important in 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.