Publication Details (including relevant citation information):
Contract Pharma May 2014.
Conventional economic wisdom holds that drugs, both branded and generic, can be made by low cost providers, assuming that products will be good enough quality to treat a patient. The reality is that it takes enormous and complex effort by a manufacturer to follow Good Manufacturing Practices (GMP) to achieve drug safety and effectiveness.
While some companies focus on quality, many drug companies and drug stores have switched to low cost manufacturers and have not monitored or supervised their performance properly, resulting in low quality, unsafe drugs and drug recalls. Many companies use English speaking auditors to audit suppliers who cannot thoroughly evaluate foreign facilities.
Companies that outsource should use the same standards auditing all their suppliers before selection. This means auditors must be very fluent in the supplier’s language, highly GMP trained and very thorough. Auditors not fluent in the language are inadequate, since reliance on translations prevents them from seeing what is really happening and the accuracy of translation is suspect. That is why the FDA and the European Medicines Agency, who use inspectors fluent in the relevant languages, often find fraudulent test and quality control data and so many quality problems at these drug facilities, especially in India and China.
U.S. consumers don’t know if the drugs and dietary supplements they buy are made properly, who made them and where or how they were made. People trust a brand name, when in fact the product is not made by that brand name owner, only distributed and marketed by them. The name on the package is seldom that of the actual manufacturer of the drug inside the package and the address is very seldom that of the actual manufacturer.
Consumers don't know that the manufacturer and marketer decide whether or not a drug batch is good and there is no routine independent testing. Consumers should know where their drugs are made so they can make an informed decision.