Countering the Problem of Falsified and Substandard Drugs

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The adulteration and careless manufacture of medicines is an old problem, vastly aggravated by globalization. The US Food and Drug Administration commissioned the Institute of Medicine to investigate the global problem of falsified and substandard drugs, considering the causes and possible solutions to this international public health crisis. In its consensus report, the committee identified two main categories of drug quality failures of public health concern. Falsified drugs carry a false representation of identity or source; substandard drugs fail to meet the specifications set in the national pharmacopeia or the manufacturer’s dossier. In practice, these categories overlap, but they are sufficiently precise for public discourse.

It is difficult to measure the global market for falsified and substandard drugs, but there is good evidence that they are a problem in poor countries with weak drug regulatory systems. All classes of drugs are compromised, especially inexpensive antibacterial and antimalarial treatments. When fake antimicrobials contain sub-therapeutic doses of active ingredients, they encourage drug resistance, shortening the effective life of a drug and hastening the expense of new drug development. The trade in fake medicines erodes patient confidence in allopathic medicine and the public health system. The organized fraud that allows the drugs to circulate undermines all public institutions and conveys money and power to criminals.

Investment in drug manufacturing could improve drug quality in low- and middle-income countries, and development finance organizations are well positioned to make these investments. Changes to procurement practices could also help guarantee that honest manufacturers get the largest market share. Most of all, low- and middle-income countries need better regulatory systems. The first step to building these systems is developing a strategic plan for the agency improvement. Changes to the drug distribution system could protect the drugs supply. In the United States, licensing only wholesalers that meet National Association of Boards of Pharmacy accreditation standards would reduce the hazards of secondary wholesale, as would a congressionally mandated track-and-trace system. In developing countries, governments should use franchising, accreditation, low-interest loans, and task shifting to create an environment conducive to quality drug retail. There is also a need for sturdy and inexpensive detection technologies that can be used to detect fake medicines in the field. A WHO International Code of Practice on falsified and substandard drugs would facilitate international cooperation against falsified and substandard drugs.