Warning issued to 15 companies in India.
By Deepak Chitnis
WASHINGTON, DC: The United States’ Food and Drug Administration (FDA) has initiated a crackdown on so-called “natural” diabetes medications that originate in India but are sold in the US. The FDA has issued “warning letters” to 15 different drug companies based in India, in which the FDA warns that “Failure to promptly correct the violations may result in legal action, including product seizure, injunction, and/or criminal prosecution.”
The sale of these drugs in the US is illegal but has been going on for many years, and the FDA has been aware of it. They have advised consumers in the past not to purchase and use these products because “they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they should be marketed as prescription products”. But sales have continued and the FDA has finally decided to put a definitive end to them.
Companies that received an FDA warning letter include Amrutam Life Care, seller of products such as Arexi, Diexi, and Obexi. Many of their drugs were found to have undeclared ingredients and were therefore deemed unfit for sale, yet they were sold anyway.
Since India is the second-highest exporter of pharmaceuticals to the US, the FDA and Indian companies have tangled quite a bit, especially in recent years – companies like Sun Pharma, RPG Life Science, Wockhardy, and Fresenius, among others.
Because diabetes is such a serious problem in the US – roughly 26 million citizens suffer from it – the FDA finally decided that enough is enough. It remains to be seen whether its warning letters, which also advise companies to revise their social media websites to make sure there are no fraudulent claims about their products on them, will have any effect.
To contact the author, email to deepakchitnis@americanbazaaronline.com