Governments should establish a national DRA with the following responsibilities:

- Licensing/authorization of drugs that may legitimately be supplied through the national drug distribution channels. While drug licensing/authorization cannot totally prevent counterfeit drugs in national distribution channels, it can substantially reduce their presence. Imported drugs should be licensed only when there is satisfactory evidence that they are manufactured in establishments with proven records of good manufacturing practice (GMP) and drug manufacturers should be licensed/authorized only if they comply with GMP requirements.

- Establishment of a system of import licensing/authorization for imported drugs. This should ensure that imported drugs are accompanied by certificates complying with the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce.

- Inspection of drug manufacturers, importers, distributors and suppliers as well as producers of packaging materials. There should be sufficient and adequately trained DRA inspectors to control the authorized operations. The inspectors should have authorization: to enter premises and seize any drugs suspected of being counterfeit; and to seal and close premises and establishments suspected of manufacturing, importing, exporting, distributing or selling counterfeit drugs pending prosecution, provided these actions are not contrary to national laws.

- Provision of standard operating procedures (SOPs) and guidelines for the inspection of all licensed/authorized premises and the national drug distribution channels (21).

- Development of appropriate procedures for the rapid assessment of suspected counterfeits and the rapid identification and quantification of their active ingredients. Small DRAs should, at least, be able to carry out simple screening methods on drugs and so be able to quantify the active ingredient(s) present.

- Investigation of all reports of drug counterfeiting.

- Dissemination of information on the existence of counterfeit drugs in the national distribution channels, as quickly as possible, to health professionals. The "Drug alert notice" approach could be used when there is a significant hazard to public health.

- Informing the public as necessary, by warnings in the mass media, of the existence of counterfeit drugs in the national drug distribution channels. If possible this should be done without generating panic or causing people unnecessarily to stop taking their medication.

- Prosecution of persons and establishments suspected of manufacturing, importing, exporting, distributing, supplying and selling counterfeit drugs.

- Requiring drug importers to carry out analyses on imported drugs if necessary.

- Provision of adequate training for personnel involved in drug inspection and quality control services and of adequate resources for the optimal performance of their duties.

- Establishment of standard operating procedures for use by licenced/authorized drug distributors/manufacturers should they observe or suspect the presence of counterfeit drugs in the national distribution channels. Procedures for the recall and immediate removal of counterfeit drugs in the national distribution channels should also be established.

- Control of drug movements in free trade zones.