DEAR DR. GOTT: Are generic prescription drugs from India safe to use?
DEAR READER: Outsourcing is all too common today, whether we are talking about a pair of rubber boots or something as critical as cardiac medication. India has more facilities making drugs and drug ingredients for the American consumer than any other foreign nation today.
The Food and Drug Administration is responsible for ensuring the safety of all drugs made for American use regardless of where they were manufactured. However, during the past seven years, the FDA has conducted just 200 inspections at plants in both India and China, and many of those inspections were done with prior notice. As a comparison, 1,222 quality-assurance inspections were made in U.S. manufacturing plants in 2007. In the United States, the FDA performs spot inspections without advance notice. This keeps pharmaceutical companies on their toes more than they would be with advance notice. The FDA claims they are unaware of any health issues caused by drugs imported from India, but it also acknowledges that it would be impossible to determine whether contamination or poor quality causes some patients to get sicker or remain ill.
India is currently producing both finished drugs and drug ingredients for more than 350 types and strengths of heart medicines, antibiotics and antidepressants. Just 10 years ago, they were responsible for only eight. This is largely because of cost. Americans want cheaper drugs, and these countries can make them for much less than U.S.-based companies. While most of these manufacturers provide high-quality products and ensure they meet FDA requirements, some companies are less than honest. No matter where production occurs, counterfeit drugs are a problem. However, in India and China, this risk is increased simply because someone is out to make a quick buck.
The FDA needs to increase its overseas inspections (without notice to the plant). This is the only way to be sure that U.S. importers and consumers are receiving high-quality products.
Several organizations in the United States and abroad are urging the FDA to increase foreign inspections. If a foreign manufacturer in on the up-and-up, he should have no concerns. This will not only provide peace of mind to consumers, but it will help weed out the "bad guys."
I recommend that anyone who wants the FDA to take greater responsibility write or e-mail the organization to express their opinions. Perhaps if enough Americans come forward, we can achieve change.
To give you related information, I am sending you a copy of my Health Report "Consumer Tips on Medicines." Other readers who would like a copy should send a self-addressed, stamped, No. 10 envelope and $2 to Newsletter, PO Box 167, Wickliffe, OH 44092. Be sure to mention the title.
DEAR READER: Outsourcing is all too common today, whether we are talking about a pair of rubber boots or something as critical as cardiac medication. India has more facilities making drugs and drug ingredients for the American consumer than any other foreign nation today.
The Food and Drug Administration is responsible for ensuring the safety of all drugs made for American use regardless of where they were manufactured. However, during the past seven years, the FDA has conducted just 200 inspections at plants in both India and China, and many of those inspections were done with prior notice. As a comparison, 1,222 quality-assurance inspections were made in U.S. manufacturing plants in 2007. In the United States, the FDA performs spot inspections without advance notice. This keeps pharmaceutical companies on their toes more than they would be with advance notice. The FDA claims they are unaware of any health issues caused by drugs imported from India, but it also acknowledges that it would be impossible to determine whether contamination or poor quality causes some patients to get sicker or remain ill.
India is currently producing both finished drugs and drug ingredients for more than 350 types and strengths of heart medicines, antibiotics and antidepressants. Just 10 years ago, they were responsible for only eight. This is largely because of cost. Americans want cheaper drugs, and these countries can make them for much less than U.S.-based companies. While most of these manufacturers provide high-quality products and ensure they meet FDA requirements, some companies are less than honest. No matter where production occurs, counterfeit drugs are a problem. However, in India and China, this risk is increased simply because someone is out to make a quick buck.
The FDA needs to increase its overseas inspections (without notice to the plant). This is the only way to be sure that U.S. importers and consumers are receiving high-quality products.
Several organizations in the United States and abroad are urging the FDA to increase foreign inspections. If a foreign manufacturer in on the up-and-up, he should have no concerns. This will not only provide peace of mind to consumers, but it will help weed out the "bad guys."
I recommend that anyone who wants the FDA to take greater responsibility write or e-mail the organization to express their opinions. Perhaps if enough Americans come forward, we can achieve change.
To give you related information, I am sending you a copy of my Health Report "Consumer Tips on Medicines." Other readers who would like a copy should send a self-addressed, stamped, No. 10 envelope and $2 to Newsletter, PO Box 167, Wickliffe, OH 44092. Be sure to mention the title.