U.S. FDA Chief Visits India After Generic Drug Quality Dangers Arise

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--As quality concerns escalate regarding generics produced in India and sold in the U.S., the U.S. Food and Drug Administration (FDA) is taking a more proactive stance. The situation has become serious enough that FDA Commissioner Margaret Hamburg traveled to India earlier this month to meet with that country's regulators.

"Copy-cat" drugs are a big business, with IMS Health predicting that the global generic market will reach $169 billion in 2014, thanks to a growth rate of 12% to 16%. India's piece of that very lucrative pie is estimated at nearly $20 billion--although firm numbers are scarce, if available at all, as the Indian generic industry has managed to escape close scrutiny until recently.

With an increase in FDA "in-country" inspections of Indian generic manufacturing plants on the horizon, some parameters for these inspections were set during Hamburg's visit. The FDA will notify Indian drug regulators prior to the inspections, and local regulators will join the FDA teams that are making the facility assessments. While in India, Hamburg met privately with 16 drug company and industry officials.

The commissioner has announced the formation of the Office of Pharmaceutical Quality to improve the agency's scrutiny of drug production across the board. Rather than wait to uncover problems during inspections, the agency is working with the drug industry to develop methodology to help identify manufacturing plants that are straying from standards and need inspection.

In recent months, quality issues forced both India's Ranbaxy Laboratories Limited and Wockhardt Limited (Wrexham, England) to stop selling any generic drugs made in a number of their Indian plants to the U.S. and parts of Europe. In January 2014, a fourth Ranbaxy facility was banned from U.S. exports after FDA inspectors found that certain drugs were re-tested to gain favorable results after initially failing.

As the number of Indian generic drug exports to the U.S. and quality issues have intensified in recent years, these problems have caused serious concern among U.S. medical professionals, including physicians, researchers and patient advocates. The depth of those concerns spurred a hearing with U.S. lawmakers on February 26, 2014.

For related information see July 25, 2013, article - Bad Medicine: Global Concerns Rise Over India's Mounting Drug Quality Problems.

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Physicians, including Cleveland Clinic cardiologist Harry Lever, will testify at the Congressional hearing about their concerns and actions regarding the dangers of inferior drugs. Lever says that various generic drugs for heart failure made by India-based companies often do not work the way they should. He is currently awaiting results from drug samples he has sent to Dr. Preston Mason, a researcher at Brigham & Women's Hospital-Harvard Medical School in Boston.

In June 2013, Mason released a report on the test results of 36 different generic versions of the most widely prescribed statin, atorvastatin. The generics were procured from pharmacies in North America, Europe and Asia to "evaluate the chemical purity of generic atorvastatin." These generics were compared to the original atorvastatin, patented by Pfizer Incorporated (NYSE:PFE) (New York, New York) as Lipitor, and Mason claimed the results were "alarming."

The "widely available" generics were found to contain an impurity that "may compromise global efforts toward the effective management of hypercholesterolemia among patients with cardiovascular risk," according to Mason. Simply put, the drugs might not work.

The same report noted that no quality issues were found in the drug products tested that were manufactured by generic companies Mylan Incorporated (NASDAQ:MYL) (Cecil Township, Pennsylvania) and Actavis Plc (NYSE:ACT) (Dublin, Ireland).

Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, three offices in North America and nine international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle™, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities.