Eight years ago, I was emailed by a whistle-blower at the big Indian pharmaceutical company Ranbaxy who claimed that the company had falsified data on drugs destined to be purchased with U.S. tax dollars. Most of the problems were with HIV medication sold to Western donors for use in Africa. But the more I probed, the more problems I found.
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I was obviously not alone in my concerns. In 2010, after several years of investigations, the U.S. Food and Drug Administration (FDA) restricted the sale of some 30 Ranbaxy pharmaceuticals in U.S. markets. This was embarrassing for all concerned because Ranbaxy had been granted the exclusive six-month generic license to produce Lipitor, Pfizer's blockbusting anti-cholesterol drug, when it came off patent last November.
Ranbaxy says it has cleaned up its act, and perhaps it has. But the case raises a broader question -- one likely to become increasingly troubling as emerging-market pharmaceutical companies that manufacture generics expand their market shares in both developed and developing countries: How can we know for certain?
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The question is particularly apropos for India, which is becoming a global powerhouse in generic drugs and depends on their regulatory watchdog, the Indian Central Drugs Standard Control Organization (CDSCO), that has been labeled corrupt by India's own Parliament. So while India is home to a number of reliable pharmaceutical manufacturers, a regulator known for unsavory collusion with less reliable ones continues to cast doubts on the quality of Indian-made drugs.
Even in the United States, and despite FDA regulation, there is evidence that quality control in imported generics is a significant problem. Consider the experience of Dr. Harry Lever of the Cleveland Clinic, who (like all cardiologists) uses diuretics, including furosemide, to help prevent heart failure. Some of my patients, recalls Dr. Lever, "were taking the brand medication [Lasix], then under cost pressure from insurers; I switched them to a generic and they reacted very badly. Only when I switched them back did they recover."
Dr. Lever, and virtually every other practicing physician in America, used to assume that generic drugs were as reliable and effective as the brand-name versions. After all, before generics can be sold in the United States, manufacturers must prove to the FDA that their medication works the same as the original drug.
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