We are affected by medicines because of the Active Pharmaceutical Ingredients or API which is in them. Patents are supposed to uphold the integrity of these APIs however a recent development in the pharmaceutical world means that there are thousands of off-patent drugs used in countries around the world. 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 APUIs could contain toxic chemicals because they have not been through GMP auditing. The length of the supply chain that these falsified APIs travel along makes it difficult to inspect whether they are toxic or not. Cheaper labour costs have led to many companies outsourcing the API production to India and China. However, this long supply chain makes it incredibly difficult to inspect every aspect of production.
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. 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.
GMP Auditing over the past 10 years has seen rising numbers of substandard Active Pharmaceutical Ingredients discovered in Indian and Chinese manufacture bases. 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. 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. However one thing is for sure, it is morally abhorrent to release deadly APIs onto the market all in the name of bigger profits.