By Mark Wachtler
April 1, 2014. (ONN) Complaints of bad drugs coming from India are so widespread across America these days, the FDA has stepped up its bans on pharmaceutical manufacturers there. Doctors have responded by prescribing specific brands of drugs. And emergency rooms are learning to ask two questions - what medications did the patient take, and the new question, where was it manufactured?
Image courtesy of Business-Standard.com, data from FDA.
Statistics that sum up just how pervasive the problem with faulty and counterfeit drugs in America is include the fact that 85% of all pharmaceutical drugs taken in the US are generics. And 40% of all generic and over-the-counter drugs taken in the US are made in India. With widespread corruption and very little manufacturing oversight in that nation, millions of Americans are unsuspecting victims of bad drugs.
FDA bans on Indian pharmaceuticals
When the US Food and Drug Administration announced a ban on drugs manufactured at an Indian plant operated by Sun Pharmaceutical two weeks ago, it was just the latest in a string of horrifying discoveries regarding the quality, or lack thereof, of drugs currently manufactured in India and sold in the United States. Four months ago, the FDA banned drugs made by India’s Wockhardt. And in two separate actions just before and after that, the agency banned drugs made by India’s Ranbaxy Laboratories. Those are three of India’s largest drug makers.
Suggesting that the volume of tainted or fraudulently manufactured drugs in India isn’t getting any better, the FDA banned pharmaceutical drugs from the same Indian company this past January, exactly two years after the last time it banned drugs made by the same company in the same country - India.
“The US Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products,” said the FDA announced three months ago, “The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.”
Two weeks ago, the FDA added certain generic drugs made by the large Indian drug maker Sun Pharma to the list of banned pharmaceuticals from that country. As detailed by Chemical and Engineering News last week, ‘FDA hasn’t revealed what manufacturing deficiencies its inspectors found, but the problems were likely serious.’ The industry publication reached out to one of their regular experts, Peter Saxon, a manufacturing compliance specialist. Saxon told the news outlet, “An import alert is usually issued if the firm falsified documentation or when gross contamination is proved or observed.”
Doctors take matters into their own hands
News reports over the past two weeks, including Reuters and Yahoo News, are describing scenes across the country where American medical professionals have been left to fend for themselves and protect their patients from the adverse effects of tainted Indian drugs. The main reason is that the FDA takes years to address deadly problems in the industry and the US agency leaves the Indian manufacturers to inspect themselves instead of using FDA inspectors already stationed in the country.
"I'm just beginning to realize the gravity of the problem," Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, told Reuters, "It's terrible and it is starting to get a lot of traction among physicians." Cardiologist Harry Lever, another doctor at the same US facility added, “We are losing control over what people are swallowing.”
Dr. Lever is one of the growing army of doctors who is paying just as much attention to a drug’s manufacturer as they are to the dose and strength. “Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it,” he said, “I’m tending to stay away from India. There’s something wrong. Too many things are happening.”
Indian drug manufacturers respond
In 2012, the Indian government responded to widespread complaints regarding the corrupt and allegedly illegal tactics used by India’s pharmaceutical industry and the hundreds of manufacturing facilities responsible for over $14 billion in annual drug sales. The government investigation found almost the exact same bad practices in India that have existed in the US for decades.
Reuters described the investigation writing, ‘A 2012 report by India's parliament alleged collusion between pharmaceutical firms and officials at the Central Drugs Standard Control Organization (CDSCO), the country's drugs regulator, and described an agency that was both understaffed and under-qualified.’
The head of the Indian Medical Association defended his country’s drugs and turned the tables on US manufacturers. “Our drugs are being sold in many countries and being accepted. So we have no issues," the IMA’s Narendra Saini shot back, “How do I know that Western drugs are better than our drugs?"
Americans betrayed by Washington
Some US doctors aren’t waiting around for the FDA to watch as Indian drug manufacturers police and regulate themselves. As explained by Dr. Richard Kovacs from the American College of Cardiology, “The average US cardiologist has been able to assume that the drugs were safe and effective. It now appears we need to be more vigilant as a profession, and assist the FDA by reporting cases where we are concerned about irregularities in the drugs supplied to our patients."
What kind of irregularities? Dr. Joel Zonszein from Montefiore Medical Center in New York told of one recent experience his patients found themselves in, “When patients open the bottle of medication, it smells like dead fish.”
While name brand drugs aren’t immune from manufacturing problems, generic drugs are more likely to be improperly made. Patent-holding name brands are sold at much higher profit margins and can afford better quality control. Generics, which make up 85% of all pharmaceuticals consumed in the US, are sold cheap and made cheap. They’ve proven to be much more prone to dangerous substitute ingredients or tainted manufacturing conditions.
And for the millions of unsuspecting Americans who’ve taken the possibly tainted Indian generics, including people that have suffered from adverse reactions, there is little or no legal recourse available to them. In July 2013, the US Supreme Court quietly ruled that all generic drug manufacturers were exempt from customer lawsuits. That’s a shame, considering pharmaceutical drugs are the number one cause of accidental death in the US.
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