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The Food and Drug Administration recently seized substantial numbers of generic drugs that did not live up to good manufacturing practices. This is not the first time the feds have taken action on generic products that did not meet quality standards. Last fall, the FDA halted imports from India's largest generic drug maker, Ranbaxy, after finding evidence of fraudulent behavior and violations of manufacturing practices. More recently, a large number of generic drugs made by the Ethex Corporation were recalled for manufacturing problems. Oversized tablets may have delivered too much medication. Shortages of certain crucial drugs occurred as a consequence. Now, the FDA has gone after another generic drug company called Caraco. The agency seized 33 different medications including popular beta blockers like atenolol and metoprolol as well as the heart drug digoxin and the sleeping pill zolpidem. Caraco had been warned last fall that it was not in compliance, but had not made adequate progress in addressing the violations. This led to the recent seizures. Although FDA has confiscated the medications the agency advises patients to keep taking any Caraco products already in their medicine chests. With FDA stepping up its enforcement of manufacturing plants, consumers may have more confidence that the agency is cracking down on substandard generic products.
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This doesn't surprise me at all! I recently was diagnosed with hyperthyroidism.... Grave's Disease to be exact. After irradiation, my endocrinologist prescribed synthetic thyroid hormone replacement. But something wasn't working exactly right. She kept testing me every couple of weeks and finally admitted that "at first" I needed to take the "name brand" medication.
Maybe later I could buy the generic product, after my dosage could be established. This was kind of expensive, so I talked to the Pharmacist, and he spilled the beans. He told me that there were two types of meds you do NOT want to take the generic form. One was heart medication, the other was thyroid medication! The simple explanation was that the quality of those generics was not consistent or reliable!! So I pay a little more for peace of mind! But it is scary, since I may have to take other generics!
Its wrong IMO to generalize generic medicines as substandard ones. In India the majority of medicines are generics. Even the ones under patent protection in US like Viagra are manufactured as generics by the top pharmaceutical manufacturers like CIPA and Ranbaxy who are worth billions of dollars and its done with Govt approval ofcourse. I mean middle class Indian earns 20,000 RS, you cant expect him to spend 10,000 in medicines. This is the reason why the Indian Govt has allowed this by not recognizing product patents (it mainly recognizes process patents)
Healthcare in the private hospitals in India is world renowned with scores of American and European availing its lesser health costs by adopting medical tourism. So, I dont understand the fuss.
PEOPLE'S PHARMACY RESPONSE:
We have no doubt that there are excellent pharmaceutical manufacturers in India. The trouble is that some have gotten into quite a lot of trouble with U.S. authorities for bad behavior.
Ranbaxy, for example, had serious problems with the U.S. FDA and the U.S. justice system for violating rules and standards. In addition, the U.S. FDA does not have the resources to visit and monitor every manufacturing plant in India and China as called for by U.S. law.
Can you absolutely guarantee that every manufacturer of generic drugs in China and India that is exporting raw ingredients or finished pills to the U.S. is perfect? Would you be wiling to bet a year's salary that there are absolutely no problems with any generic drugs? We certainly wouldn't make that bet.