GMP Auditing And Dangerous APIs
The part of a drug that makes us better is the Active Pharmaceutical Ingredients or API. 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. One of the main problems with knowing whether the API in a drug is falsified or not is because of the long supply chain that many medicines go through before they reach their final market. Cheaper labour costs have led to many companies outsourcing the API production to India and China. 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.
With so many drugs entering the EU market, there are unknown numbers of health problems that could occur. Patients could end up dead if they are given drugs containing toxic APIs. This could be done through accidental overdose if the API is similar to any other medication that they are taking, or it might also occur in a case where two different APIs react fatally with each other.
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.












