India’s pharmaceutical industry is in trouble — safety concerns, falsified drug test results and selling fake medicines, are just some of the “issues” facing drug makers there.
Why should you care? Because 40 percent of the generics and over-the-counter prescription drugs consumed in this country come from India.
Still not overly concerned?
The FDA recently banned India-made generic versions of Accutane (for acne), the pain drug Neurontin and the antibiotic Cipro, “that the FDA determined were adulterated.” (See “Medicines made in India set off safety worries,” by Gardiner Harris, New York Times, Feb. 14)
Don’t take anything stronger than aspirin?
Mostly made in Thailand and China.
Don’t take anything stronger than vitamin C?
Most of it comes from China, according to Harris, who also spoke on the Diane Rehm Show, produced by WAMU radio in Washington, D.C., and aired on Public Radio stations.
According to Harris’ report in the New York Times, the FDA has ramped up its inspection of overseas drug makers, in India and elsewhere, after reports of safety concerns surfaced. And what they are finding should be of grave concern to all of us.
Or in the case of China, what they aren’t finding. There are FDA offices and inspectors in several Chinese cities, but, FDA Commissioner Dr. Margaret Hamburg acknowledged, the inspectors aren’t always allowed in plants. And according to Harris, the FDA is having trouble getting China to approve the additional visas the FDA has sought for two years to improve operations in China.
So now you may be wondering where your drugs come from? Good luck finding that out. Unlike shirts, shoes and scrub brushes that carry “Product of” or “Made in” declarations on the labels, drug labels frequently don’t list the country of origin.
And if a drug is manufactured in this country, it is, highly likely the actual drug ingredient comes from a foreign country,according to Harris.
Gradually, bit by bit, over the past 20 or 30 years, the manufacturing of the drugs in this country has drifted across the ocean to countries where drugs, like many other goods, can be produced more cheaply — something Americans like. But at what cost?
It’s a high-stakes bet on our own government’s ability to get control of a situation involving private manufacturers on foreign soil where our “power” is largely tied to our diplomacy and where we must convince these companies selling in the U.S. is worth what it will cost them to bring their practices up to U.S. standards.
And it’s going to cost them plenty. According to Harris’ NYT story, Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to “felony charges” and paid a $500 million fine last year, in a case brought about by the FDA’s increased enforcement.
How well will this work?
It’s hard to tell, but if the following reported reactions from Indian officials are any indication, it’s going to be a tough battle.
“There are people here who have a very sinister view of the FDA inspections,” said Kesahv Desiraju, India’s health minister.
“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those,” said G.N. Singh, India’s top drug regulator.
Still think the U.S. is too eager to regulate and too quick to get involved in the business of other countries?
Are you willing to bet your health on that?
We hope not.