DEAR DR. GOTT:
Are generic prescription drugs from India safe to use? Thank you for your input.
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 now has more facilities making drugs and drug ingredients for the American consumer than any other foreign nation today.
The Food and Drug Administration (FDA) 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 US manufacturing plants in 2007. In the US, 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 also admits it would be impossible to determine if contamination or poor quality causes some patients to become 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 ten 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 US 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.
In my opinion, the FDA needs to increase its over-seas inspections (without notice to the plant). This is the only way to be sure that US importers and consumers are receiving high-quality products.
To the best of my knowledge, several organizations in the US 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 (and many are asking for more inspections). This will not only provide peace of mind to consumers, it will help weed out the so-called “bad guys”.
I recommend that anyone who wants the US FDA to take greater responsibility write or email the organization to express their opinions. Perhaps if enough Americans come forward, we can achieve change.
If you would like to read more about this topic, I direct you to an article (“FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.”) written June 17, 2007 by Marc Kauffman for www.WashingtonPost.com.
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, number 10 envelope and $2 to Newsletter, PO Box 167, Wickliffe, OH 44092. Be sure to mention the title.
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