Two China
GMP Auditing And Finding The Manufacturers Of Falsified APIs
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.
many of these falsified APIs do not go through GMP auditing and so it is unknown of they contain toxic chemicals. The length of the supply chain that these falsified APIs travel along makes it difficult to inspect whether they are toxic or not. China and India have become the two biggest countries for APIs to be outsourced to because of cheaper labour costs. 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.
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. 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in the number of substandard APIs coming from Indian and Chinese manufacturers. 50 GMP certificates were suspended or withdrawn from 160 production bases by the European Directorate for the Quality of Medicines and Healthcare. These figures have been estimated to grow even further over the next few years.
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.
Two – China Girl.mp4