We are affected by medicines because of the Active Pharmaceutical Ingredients or API which is in them. 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 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. China and India have become the two biggest countries for APIs to be outsourced to because of cheaper labour costs. auditing every stage of production from these countries to the finished product is difficult with so many countries involved.

The European Fine Chemical group has estimated that 80% of medicines which are used in Britain contain APIs from India and China and the European Directorate for the Quality of Medicines and Healthcare (EDQM) has stated that through the results of its audits, ads much as 20-30% of all off-patent medicines in the EU could contain falsified APIs.

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.

Indian and Chinese manufacturers have been found to produce an increasing number of substandard Active Pharmaceutical ingredients over the past ten years as shown in the results of GMP Auditing. 50 GMP certificates were suspended or withdrawn from 160 production bases by the European Directorate for the Quality of Medicines and Healthcare.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 the only way to catch the producers of falsified APIs and it is one of the most important aspects of the pharmaceutical industry. But it is a moral issue that companies are prepared to release substandard and potentially fatal drugs onto the market all in the name of bigger profit margins.