Legislative Measures for Dealing with Counterfeit Drugs in Developing Countries *

Abstract

The ubiquitous presence of counterfeit drugs in several developing countries during the past few years is causing great concern. Counterfeit or substandard drugs have resulted in the deaths of hundreds in at least two developing countries, while the precise magnitude of the extent of the problem remains to be determined in many other countries. Several factors have facilitated the manufacture or distribution of counterfeit drugs in developing countries: existence of a weak or ineffective national drug regulatory authority; inadequate or unenforced laws; lax controls with regard to manufacture, importation, and distribution; weak intellectual property law systems; and lack of visibility for the problem and ineffective action. A number of measures have to be deployed to address the problem of counterfeit drugs, and among these are a sound regulatory framework and an effective enforcement machinery. In reviewing existing laws and regulations and in drafting new ones, attention must be accorded to the following matters: a comprehensive definition of “counterfeit drugs” as well as “counterfeit starting materials”; a system of licensing or registration of all products and their manufacturers, importers, and distributors; a clear demarcation of permissible activities; institutional arrangements to deal with counterfeit drugs; and measures to facilitate law enforcement and judicial proceedings. Inasmuch as the counterfeit drug industry operates as a criminal activity, it is important that the national drug regulatory authority mobilizes the resources available within other relevant agencies to develop an effective and coordinated response to this growing menace.