Drug Monitoring in Developing Countries: A Drug Regulator's Perspective

An effective system for drug monitoring is necessary in any developing country that assumes responsibility for the safety, quality, and efficacy of the medicines that are available to its people. This is achievable, given the following: 1. a national policy commitment to good standards of medicines, 2. a sound system of drug regulation that serves the principles of public integrity and accountability, and 3. government policy that respects intellectual property and the innovative nature of the pharmaceutical industry (including the generic industry).

A proposed national plan for the conduct of drug monitoring in a developing country that requires the cooperation of government, industry, academia, the national drug regulatory authority, the medical and pharmacy professions, international nongovernment donor agencies, and the public will be described. It can be supported by a small proportion of the drug vote. Veterinary, homeopathic, dental and traditional medicines, medical devices, and blood products are included. This proposal is aimed at promoting confidence in the medicines that are available and in the institutions that support them, and at encouraging autonomy and training. International sharing of data through the World Health Organization Collaborating Centre for International Drug Monitoring would be facilitated. The feasibility of the proposal can be tested theoretically and in the field.