Counterfeit-fighters face "defining" moment

In India, the government finds that 0.04 percent of drugs on pharmacy shelves are counterfeit. But the country's drug industry says the figure is 30 to 40 percent. The disparity stems from differing definitions of the word "counterfeit," a topic that continues to confound customs and law-enforcement officials, regulators, patent lawyers and even the World Trade Organization. An Indian court settled the matter in-country: "Anything that is not genuine is counterfeit. Spurious, adulterated and misbranded drugs are counterfeits," reports Moneylife. So a generic drug is not a counterfeit. But a look-alike, sound-alike product is a case of misbranding, which makes the drug a counterfeit. When third-party manufacturers in India divert surplus production to market sans brand-holder name, and undersell the brand-holder, that's a "legal counterfeit." The WHO definition includes unauthorized copies of patented molecules. "Fake," however, means the product does not have the labeled active ingredient. Got it? Article

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