Widespread manufacturing irregularities at drug factories in India are putting Americans’ health at grave risk, according to a top doctor.
The vast majority of prescription drugs sold in the U.S. – 85 percent – are generic. And many of these medications are made in India where a string of recalls has been issued because of manufacturing errors.
Even worse, there is no way for patients to know where a generic drug is produced, says renowned cardiologist Chauncey Crandall, M.D.
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“Chain drug stores order their generic medications in bulk. They put out bids and the winning bid could come from India, Pakistan, China, or even Iran,” says Dr. Crandall, author of the No. 1 Amazon best-selling book The Simple Heart Cure
“Patients have no way of knowing where generics are coming from, and this is a dangerous situation because these drugs can kill,” he adds.
Dr. Crandall’s comments come in the wake of a string of drug recalls of products made by Indian pharmaceutical companies. Some 100,000 bottles of the heart drug Toprol XL were recalled because they didn’t dissolve properly. The medication is a beta blocker taken by millions of Americans to prevent strokes, heart attacks, and sudden cardiac death.
Dr. Crandall, author of the Heart Health Report
, says he has seen firsthand among his patients the dangers posed by inferior generic medications.
“I had patients who were taking a generic version of the cardiac drug Coreg. The drug didn’t seem to be working properly and my patients were actually going into heart failure,” he says. “In my practice, I provide my patients with prescriptions for brand name drugs, but insurance companies often refuse to fill them with anything but generics.
“This is a deplorable situation throughout the U.S., but it is also especially acute in our military hospitals, where patients often get only generic drugs,” adds Dr. Crandall, director of preventative medicine at the Palm Beach Cardiovascular Clinic.
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Dr. Crandall advises taking the brand-name version of medications, not generics, whenever possible.
India provides about 40 percent of the generic drugs sold in the U.S. But in recent months the Food and Drug Administration has banned the import of medications made at facilities owned by three of India’s largest drug manufacturers, Wockhardt, Ranbaxy Laboratories Limited, and Sun Pharmaceuticals Ltd. In addition, the World Health Organization has warned that Indian drugs account for one-fifth of the fake drugs sold worldwide.
Here are some of the drug recalls resulting from manufacturing problems at major Indian pharmaceutical firms:
- Sun Pharmaceuticals recalled nearly 400,000 bottles of the decongestant cetirizine (Zyrtec) and 251,882 of the antidepressant venlafaxine (Effexor) this past May because the pills failed to dissolve properly. The drugs were distributed by the drug maker’s U.S. subsidiary Caraco Pharmaceutical Laboratories, but were manufactured in India.
- Also in May, Ranbaxy recalled 30,000 packs of the allergy drugs loratadine and pseudoephedrine sulphate extended release tablets because of manufacturing defects in packaging.
- In March, Sun recalled a batch of a generic diabetes drug bound for the U.S. after an epilepsy drug was found in it. A patient discovered the error after noticing the wrong medication in the drug bottle.
- Also in March, Ranbaxy recalled nearly 65,000 bottles of the statin drug atorvastatin calcium (Lipitor) after 20-milligram tablets were found in sealed bottles marked 10-milligrams. A pharmacist in the U.S. discovered the mix up.
- The FDA issued an alert in 2013 over manufacturing problems occurring in one of Ranbaxy’s Indian facilities and advised U.S. custom officials to hold up importation of the medications until the company complied with regulatory standards.
- In 2012, Ranbaxy recalled millions of Lipitor pills after glass particles were found in some of them.
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