There was a time when most of the medicines we purchased in our neighborhood drug stores were made in America. These days, though, medicines come from all over the globe.
Despite the high cost of prescription drugs, generic manufacturers compete on the basis of price. Just like trousers or televisions, ingredients for many medications now come from India and China where they are made at lower cost.
Although it is impossible to get exact numbers, some experts estimate that one fifth of all generic drugs and over-the-counter medicines are now made in China and India. Approximately 40 percent of the raw ingredients in our pills come from those countries.
The FDA is supposed to inspect all American drug manufacturers every two years. That’s the law. But there are no specific regulations covering plants in foreign countries. Last year, the agency inspected 13 of the 700 known Chinese factories making medicines for export to the U.S.
Even when the FDA does inspect a plant, it might be the wrong one. That’s what happened last year when the FDA confused the names of two Chinese companies. The one that was actually making the raw ingredient for heparin did not get inspected.
The current scandal surrounding heparin, an injectable blood thinner used during surgery and dialysis, revealed weaknesses in the regulatory process.
The FDA has reported hundreds of allergic reactions and four deaths linked to multiple-dose vials of Baxter brand heparin. The raw ingredients for heparin come from pig intestines often processed in factories in China.
Investigations reveal that some plants processing heparin do so as a sideline to their sausage-casing business. As a result, these firms are not registered as pharmaceutical companies and are exempt from regulation by the Chinese equivalent of the FDA.
Pig intestines are purchased from slaughterhouses, often with no paperwork to enable anyone to track the source. If the animals were sick, there is no way to detect the disease.
Some factories are literally cottage industries with low standards of sanitation and quality control. Raw heparin may be spread out on a table in a courtyard to dry. This crude ingredient is sold to middlemen who then sell it to manufacturers around the world. Their records may also be deficient.
The problems with heparin may be especially dramatic but could represent the tip of the iceberg. Many firms in China making drug ingredients are registered as chemical companies rather than pharmaceutical manufacturers. As a result, they may escape scrutiny by the Chinese drug regulatory authorities and the U.S. FDA.
Raw ingredients for many medicines are traded around the globe and the original source may be obscured in the process.
With more big-box retailers selling low-cost generic drugs, consumers may want to know where these medicines were made. We have heard from hundreds of readers about problems with certain generic drugs. To read their stories, search this Website.
Until the FDA institutes better oversight of foreign drug makers, consumers in the U.S. have no way of knowing for sure whether their medications meet quality control standards.