GMP Auditing And Falsified APIs

The part of a drug that makes us better is the Active Pharmaceutical Ingredients or API. 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. 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.

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. 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.

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. Toxic APIs could end up having deathly consequences in some 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.

GMP Auditing over the past 10 years has seen rising numbers of substandard Active Pharmaceutical Ingredients discovered in Indian and Chinese manufacture bases. 50 GMP certificates were suspended or withdrawn from 160 production bases by the European Directorate for the Quality of Medicines and Healthcare. And the EDQM predicts that these figures will continue to grow over the next decade.

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. However one thing is for sure, it is morally abhorrent to release deadly APIs onto the market all in the name of bigger profits.