to confirm that a drug is genuine. One challenge in both field and laboratory testing is determining how to combine tests for maximum efficiency. It is usually best to work through tests beginning with the easiest or least expensive ones. Only if samples pass these tests should the inspector move on to more difficult or expensive ones.

Making detection technology more accessible in low- and middle-income countries would be invaluable to controlling the trade in falsified and substandard drugs. Technologies can protect consumers and are useful to surveillance staff working to generate accurate estimates of the magnitude of the problem of poor-quality drugs. An understanding of the technological landscape, the range and gaps in available technologies, and the likely improvements in the near future is essential for using technologies in developing countries.

Recommendation 6-1: The National Institute of Standards and Technology should fund the development of a central repository for existing and newly innovative detection, sampling, and analytical technologies, ranging from field and rapid screening technology to sophisticated laboratory-based assessments, to identify substandard and falsified medicines.

CODE OF PRACTICE

Individual countries have the responsibility for protecting the national drug supply. This includes regulating good-quality manufacturers, preventing poor-quality drugs from entering the market, detecting them when they do, and punishing those who manufacture and trade them. Drug regulation, surveillance, and law enforcement are the necessary components of any national response to the problem.

A voluntary soft law such as an international code of practice could encourage international action against falsified and substandard drugs. The code of practice would contain guidelines on surveillance and international reporting of drug quality problems. The code would facilitate passage of national laws on how to punish and, when necessary, extradite those responsible for falsified drugs and criminally negligent manufacture. It would also promote harmonized regulatory standards for drug manufacture and licensing.

Recommendation 7-1: The World Health Assembly, in partnership with the United Nations Office on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsified and substandard medicines.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement