Active Pharmaceutical Ingredients or APIs are the chemicals in a pill or liquid medicine that works in our body to make us better. The growth of off-patent medicines means that a patent does not always protect the integrity of the API. With all of these drugs on the market many companies find themselves having to lower their prices to remain competitive, and using substandard ingredients is becoming an increasingly popular way to do 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 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.
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. 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. 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 one of the most important features in the pharmaceutical industry due to its inspection and findings of falsified APIs. 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.
