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That means the product is bioequivalent and, under normal circumstances, the regulatory authorities in each country routinely licence the import of the copied drugs which are sold at a big discount. This affects the profits of Big Pharma. So, equally routinely, the lobbyists employed by Big Pharma discuss generic imports with their regulatory authorities, and sometimes those discussions lead to action. First, a word of reassurance. The action I am about to discuss does not affect your ability to buy generic viagra online. Although some thirty drugs are affected, they are treatments for rather different conditions.

The FDA has issued two Warning Letters to Ranbaxy Laboratories Ltd, one of the world’s largest manufacturers of generic drugs based in India. These letters assert that Ranbaxy has not maintained proper manufacturing standards in two of its plants. Following the warnings, there is also an Import Alert that allows US customs officials to detain the finished drugs as they enter the US. These Warning Letters are somewhat controversial. There is no suggestion that the thirty drugs named on the list and manufactured in the identified plants are unsafe.

There is no product recall and no warning to patients not to continue taking the drugs they already hold. Further, there is no suggestion that the other plants where different drugs are produced are unsafe in any way. This is, at best, a technical violation by the manufacturer. But the effect on Ranbaxy’s reputation has been quite chilling and its share price has fallen. To repeat, this does not affect the generic viagra manufactured by Ranbaxy.

The politics of free trade are always complicated. When the interests of significant local industrial players are involved, there is always going to be a temptation to be protectionist. In this instance, the decision of the FDA looks suspect because it has not required a recall. By its own admission, there is nothing wrong with the generic drugs manufactured by Ranbaxy. TAs it is, there has been little comment outside the financial press discussing the effect on share price.

Having hit the jackpot with Ranbaxy, the lobbyists for Big Pharma have continued their pressure on the FDA to shut down more of the competition against their drugs. When the original manufacturers are not able to find a way to extend the patent protection, their only way of defending their profit margins is to undermine the credibility of the generic imports. The usual lines of attack always focus on patient safety. All action taken is to ensure that lives are not put at risk by imports from “foreign” countries. As with another article on this site, I emphasise this does not affect you when you buy generic viagra online. There is no action taken or threatened by the FDA to affect the import of this vital, safe and effective drug into the US. In this case, the FDA has picked on another Indian generic manufacturer, Sun Pharmaceutical Industries Ltd. However, this time the problem has been identified in quality checks at a manufacturing plant in Detroit owned and operated by Sun Pharma. To give you an idea of the scale of this company’s operations, it currently holds FDA licenses to import 96 drugs into the US. It is a major player and its activities significantly affect the profitability of the local companies. Politically, the local manufacturers benefit every time the FDA can be persuaded to take action against a generic manufacturer. It adds credibility to their general propaganda that generics are unsafe. But, as with Ranbaxy, the FDA cannot be persuaded to say that Sun Pharma’s drugs are in any way unsafe. There is no order that they be withdrawn from the market or stopped from entering the US (or, in the case of the Detroit factory, leaving that factory). Supplies are uninterrupted. But yet another seed of doubt has been planted in the public’s mind. At a time when the US has been building better ties with India, it is odd to see the FDA engaging in such obvious protectionism with two major manufacturers from a single country as its target. Nevertheless, the damage is done to the individual companies’ reputations and to their stock value. They are being punished for being too successful in competing with US business. Fortunately, none of this has affected the manufacture or supply of generic viagra which continues to be a cheap alternative to the branded equivalents. It will require a more brave head of the FDA to challenge the supply of viagra.