10.1 General remarks

Introduction

The detection and prosecution of criminals who market counterfeit pharmaceuticals have several stages. First of all, suspect products have to be traced. The drug, sampled according to an established procedure, should undergo defined physical or organoleptic examination by the drug inspector. If the results indicate that the drug formulation may be a counterfeit product, then at least some chemical tests must be repeated to confirm the necessity for further analysis. Drugs are then analysed by simple tests, including TLC. If these tests do not provide conclusive evidence and the drug is still considered to be a possible counterfeit, then a compendial procedure is required.

Throughout the investigation, it is assumed that a chain of custody has been established, i.e. the correct procedures were followed before the drug was received for analysis by the laboratory. This ensures that the results of these examinations are reliable and will be accepted as valid in future steps, e.g. prosecution of the supplier of the counterfeit pharmaceuticals. The final results shall be submitted to the appropriate official in the drug regulatory authority.

Section 10.2 describes the training necessary for inspectors. Section 10.3 describes training in the design and implementation of a specific programme for the screening of counterfeit pharmaceuticals. There are several common requirements for both inspection and chemical testing, and these are included as items in the training programmes for inspection and examination of counterfeit pharmaceuticals. It is assumed that the trainers are already suitably experienced to perform the required inspection, examination and training. The two-tiered approach of the training programme should include training of trainers, who in turn educate those who need to be trained in drug inspection and examination. The main focus of these guidelines, however, is the training of the trainees.

The practical issues to be considered in the organization and implementation of the programme are described in section 10.4.

Each country must develop its own strategy, appropriate for its situation, the availability of an institutional framework, and its professional and economic resources. Ideally it should be prepared by the country's drug regulatory authority, in consultation with all major parties involved in the manufacturing, importation, distribution, sale, prescribing and use of legitimate drugs.

Requirements and goals of the training programmes for inspection and examination

An effective approach to the detection and prevention of counterfeit pharmaceuticals requires professional competence of the personnel, motivation, and awareness of the problems.

The ultimate goals of the programme should be:

- to raise the morale of professionals involved in drug inspection and examination

- to establish a control system to prevent the flow of counterfeit pharmaceuticals into the legitimate distribution channel.

These goals cannot be achieved without the concerted effort of other programmes concerned with improvement of the pharmaceutical infrastructure. In order to ensure the quality, safety and efficacy of drug products accessible to the target population, a secured and satisfactory drug distribution system is required.

Prerequisites

The primary prerequisite for any programme combating pharmaceutical counterfeiting is the existence of an established drug regulatory authority in the country (31). That implies the existence of at least the following:

· A legal framework. The legislation is expected to cover criminal activity in relation to the manufacture, import, distribution, sale and dispensing of counterfeit pharmaceuticals. The act of counterfeiting should be an offence such that the inspector of drugs, the police and other investigating agencies are all able to take action. The law should also provide for deterrent punishments.

· A system requiring:

- licensing/authorization of manufacturers, importers, distributors, retailers and pharmacies

- licensing/authorization for marketing of drugs

- proper labelling.

· Adequate professional staff and resources within the DRA.