Can there be more than one level of drug quality?

  • by: |
  • 05/29/2014

From the pages of the Orange County Register:

Foreign meds, quality control

In the past year, several major foreign pharmaceutical companies have been forced to recall thousands of medications sold in the United States. The problems with their products were myriad, including packaging defects, dosage errors, and bacterial contamination. In one especially egregious instance, epilepsy medications were found in a bottle of diabetes drugs, resulting in the recall of more than 2,000 bottles produced by a company based in India.

Given these dangerous errors, it's little wonder that American physicians are growing increasingly worried about the safety of prescription medications imported from foreign pharmaceutical companies. Compromised medications jeopardize the health of their patients.

We must strengthen America's "pharmacovigilance." The federal government should bulk up its drug import oversight apparatus and implement a tracking system that monitors the entire life cycle of medications.

Right now, 40 percent of America's over-the-counter and generic drugs come from Indian suppliers. The World Health Organization has estimated that around 20 percent of the drugs manufactured in that country are counterfeit.

As the New York Times recently noted, at one hospital in Kashmir, fake drugs likely lead to the deaths of hundreds of infants. In January, the Indian health ministry identified at least 32 medicines being sold in Indian stores that didn't meet basic safety and quality standards. Earlier this year, the FDA's commissioner, Margaret Hamburg, expressed her dismay about "recent lapses in quality at a handful of [Indian] pharmaceutical firms.

To protect against dangerous drug imports, the FDA has established the Office of Pharmaceutical Quality, which will more meticulously monitor the quality of brand-name, generic, and over-the-counter drugs.

Congress also enacted legislation in 2012 mandating that foreign pharmaceutical manufacturers be subjected to more intense scrutiny. This bill lead to 160 FDA-conducted inspections at Indian drug manufacturers in 2013, an enormous increase over the number of site visits in previous years.

What American inspectors discovered was often profoundly disturbing.

For example, at one plant owned by the Indian pharmaceutical manufacturer Ranbaxy, the FDA found flies "too numerous to count." Ranbaxy has since been hit with half a billion dollars in fines and has plead guilty to felony charges.

These developments are all the more discouraging once situated within the broader context of the global economy. Pharmaceutical manufacturing is a $14 billion industry in India. When its firms are permitted to push sub-par medications into the U.S. health care market, they often end up displacing American companies.

Such displacement can hurt our economy. Drug firms currently support 810,000 jobs throughout the United States. More than 20 percent of the sector's domestic sales are directed back into local research and development projects.

The American pharmaceutical industry has already proven its commitment to ensuring the quality and safety of the medicines it produces. It has vigorously pushed for the federal adoption of a track-and-trace system, which would monitor a drug's journey from manufacturer to packager to distributer to pharmacy and, ultimately, to patients.

Such a system would significantly strengthen the security of America's drug supply chain.

In contrast, India is simply shrugging off its gross failures in drug production. The Indian Medical Association's secretary-general recently said: "Our drugs are being sold in many countries and being accepted, so we have no issues. How do I know that Western drugs are better than our drugs?"

That casual attitude is unacceptable. American consumers are being put at direct risk by India's malfeasance. If Indian authorities won't take responsibility, the United States must step in and ensure that proper vigilance is in place throughout the entire life cycle of a drug.

A global pharmaceutical market benefits consumers only when the appropriate safeguards are in place. The recent spate of recalls should prompt renewed dedication to pharmacovigilence.

For the sake of both American drug companies and American patients, federal regulators must work harder to ensure that all drug imports meet basic standards for quality and safety.

Peter Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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