Executive Summary For decades the FDA has made false claims regarding its ability to inspect and provide quality assurance on Indian and Chinese drug manufacturing facilities. Introduction It has proven much easier to make the claim to inspect Indian and Chinese drug manufacturing facilities than to do it in reality effectively. Wait One Second… Why…
Executive Summary Africa receives inexpensive but also low-quality drugs from both India and China. Introduction The quality of drugs shipped to Africa by both China and India is, on average, very low. The following quote is from the book Bottle of Lies. Wait One Second… Why is The Article Not Viewable? You are seeing this…
Executive Summary Ranbaxy was an enormous Indian pharmaceutical company that was caught following manufacturing standards that are very common in India. Introduction It is difficult for western audiences to wrap their heads around the manufacturing quality oversights that are commonplace in India. Wait One Second… Why is The Article Not Viewable? You are seeing this…
Executive Summary The FDA claims high degrees of bioequivalence without having evidence that what they say is accurate. Introduction There is a common presentation that generics are identical to brand-name drugs. This is expressed in the following quotation from Medical News Today. Wait One Second… Why is The Article Not Viewable? You are seeing this…
Executive Summary Indian responses to Indian pharmaceutical companies falsifying bioequivalence is highly predictable. Introduction Indians and Indian regulatory bodies do not much care about drug safety. This is an observation from many sources on the topic. And this is also found in the reactions when Indian drug companies are caught engaging in bioequivalance and manufacturing…
Executive Summary The US pharmaceutical policies result in the highest drug prices in the world. Canada has much more reasonable drug prices. Introduction Canada’s drug regulation is far more effective in managing drug prices than the US. Wait One Second… Why is The Article Not Viewable? You are seeing this text instead of the article…
Executive Summary Generics were proposed to decrease the cost of drugs in the US greatly. Why did this outcome not occur as predicted? Introduction One of the most widely accepted assumptions is that generic drugs reduce the cost of drugs in the US. We cover in this article why this assumption, while perfectly rational, is…
Executive Summary Falsifying bioequivalence tests for approval is something that is done frequently — and the FDA does not do anything about false bioequivalence when pointed directly to it. Introduction Bioequivalence, which the FDA promotes as the case with all generics, even those made in India that fail their inspections, often have their bioequivalence trials…
Executive Summary Falsifying bioequivalence is commonly done by what is called clinical research organizations or CROs. Introduction A major issue with falsifying bioequivalence is the companies paid to prove rather than test bioequivalence. These are called Clinical Research Organizations or CROs. Wait One Second… Why is The Article Not Viewable? You are seeing this text…
Executive Summary Bioequivalence testing is much more complicated and fraught with limitations than generally understood. The World Health Organization and Generic Drug Production Introduction Patients are repeatedly told that there is absolutely no difference between generics and brand-name drugs. How this assertion is proven tends to be left out of the conversation, and that is…