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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. 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. 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. Outsourcing their work to India and China is another way that some companies have saved money due to cheaper labour. 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.

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. Patients could end up dead if they are given drugs containing toxic APIs. There is a high risk of accidental overdose and serious reactions between two different APIs when toxic ingredients mix with safe prescription drugs.

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. 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. 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. 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.