Executive Summary Indian pharmaceutical plants face no regulation from Indian authorities and are constantly caught lying to the FDA and EMA. Introduction It is amazing to read articles that touch on how the FDA works or what it produces at a high level and then find out how it functions. It is as if rather…
Executive Summary The FDA allows the import of generics and the domestic manufacturer and sale of generics that it knows are not bioequivalent to the original drug. Introduction It is amazing to read articles that touch on how the FDA works or what it produces at a high level and then find out how it…
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 claim to inspect Indian and Chinese drug manufacturing facilities than to do it in reality effectively. Wait One Second… Why is The…
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. Wait One Second… Why is The Article Not Viewable? You are seeing this text instead of the article because of two potential reasons….
Executive Summary Ranbaxy was an enormous Indian pharmaceutical company 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 commonplace in India. Wait One Second… Why is The Article Not Viewable? You are seeing this text instead of the…
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. Wait One Second… Why is The Article Not Viewable? You are seeing this text instead of the article because of two potential reasons. Reason…
Executive Summary Indian responses to Indian pharmaceutical companies falsifying bioequivalence are highly predictable. Introduction Indians and Indian regulatory bodies do not care much about drug safety, which is an observation from many sources. And this is also found in the reactions when Indian drug companies are caught engaging in bioequivalence and manufacturing fraud. Wait One…
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 are done frequently — and the FDA does not do anything about false bioequivalence when pointed directly to it. Introduction The FDA promotes bioequivalence as the case with all generics, even those made in India that fail their inspections, often have their bioequivalence trials falsified. Wait One Second……