The GPHF-Minilab^® -
Protection Against Counterfeited and Substandard Pharmaceuticals

Counterfeit medicines are a serious and increasing threat to health care. The World Health Organisation (WHO) assumes that up to ten percent of medicines available worldwide are counterfeit or of poor quality. Affected above all are developing countries where the conditions for effective control of drugs are still often lacking.

With the GPHF-Minilab® the Global Pharma Health Fund e.V. (GPHF) offers a unique mobile mini laboratory that can test the quality of medicines in the shortest time and thus close the gaps in the supervision of medicines. 

Over 300 GPHF-Minilabs® have been supplied to more than 70 countries already. They protect people from the often deadly dangers of counterfeit medicines.

Simple Test Methods for the Quality Assurance of Pharmaceuticals

Counterfeit and "Substandard" Pharmaceuticals
Counterfeiting of pharmaceuticals and the proliferation of substandard drugs constitute a serious health risk for the world population. Experts assume that currently as much as seven percent of the world’s total pharmaceutical sales is counterfeited or of dubious quality. Worst hit are the populations of developing countries for whom high-quality and inexpensive basic drugs are not readily available in sufficient quantities. In addition, the resources for implementing effective drug quality control systems are not yet readily available in these countries.

In the face of this situation, the Global Pharma Health Fund e.V. (GPHF) has developed some simple and tropics-compatible test methods designed to protect people in developing countries against the - frequently fatal - consequences of taking counterfeited or substandard pharmaceutical drug products. These methods were developed in cooperation with the School of Pharmacy at the University of Bonn and the Department of Tropical Medicine at the Medical Mission Institute in Wuerzburg, Germany.

The objective of this project is the provision of simple test methods which enable identification of substandard or counterfeited pharmaceuticals under the specific conditions encountered in developing countries. The respective methods and equipment should be inexpensive, mobile and versatile. Another important feature is their usability by less intensively trained staff in developing countries.

After several years of development, the GPHF-Minilab® was subjected to lengthy field testing in the Philippines, Kenya, Ghana and Tanzania in 1997 and 1998. These tests confirmed the Minilab as a practical and effective tool for the identification and quality assurance of pharmaceutical drug products.

The trials have also confirmed that the Minilab tests can be easily performed in hospitals, rural health care clinics and pharmacies. Furthermore, all methods are also suited for use at airports, harbours or customs offices. Thus, for professional bodies and organizations working in public health care in developing countries, the GPHF-Minilab® is a highly valuable tool for improving the quality of drug supply.

Testing the quality of drugs using the GPHF-Minilab® involves a four-stage test plan that employs very simple physical and chemical-analysis techniques:

1. A visual inspection scheme of solid dosage forms including associated packaging material for a rapid rejection of crudely presented counterfeits.
2. A simple tablet and capsule-disintegration test for a preliminary assessment of deficiencies related to drug solubility and availability.
3. Simplified colour reactions for a quick check of any drug present, thus ensuring the drug’s identity.
4. Semi-quantitative thin-layer chromatography tests for a check of any quantities of drug present, thus ensuring the drug’s identity.

The GPHF-Minilab® has been designed such that all the devices and resources required for drug testing fit into two transportable units each the size of a standard suitcase and with a total weight of about 40 kg. Thanks to its low weight and independence from external power supply the GPHF-Minilab® is a truly mobile system ideally suited for use in the field.

The GPHF-Minilab® is equipped with a full set of reference substances for the 40 active substances selected and contains all necessary laboratory equipment such as test tubes, mixing beakers, pipettes, DC plates and chambers and battery-powered UV lamps of various preset wavelengths.

The GPHF-Minilab® is supplied complete with several manuals containing complete instructions for performing the tests. They include many descriptive pictures and illustrations and are available in English, French and Spanish versions. The instructions contain detailed step-by-step descriptions of all analytical methods and operation procedures required for the tests. The manuals are complemented by a summarized version on plastic-coated sheets resistant to spillage for routine bench work.

In addition, the start-up package of the GPHF-Minilab® contains all reagents and solvents required which are also supplied separately. Finally, reliable laboratory management is facilitated using the reporting, stock-record and order forms supplied.

In addition to reliability and versatility in use, a low initial-purchase price was one of the top priorities in the development of the GPHF-Minilab®.

The overall priority for the GPHF-Minilab® development was to present reliable test methods and a simple and versatile technology. In addition, the GPHF-Minilab® should be affordable to all target groups. After intensive development work and product sourcing the entire test system of the GPHF-Minilab® can now be offered at a very favourable rate reflecting cost price only plus the cost of shipment, customs duties and taxes.

The quantities of reagents and solvents supplied in the start-up package are sufficient to perform at least 3,000 colour-reaction identity tests and 1,000 TLC (thin-layer chromatography) runs to verify drug potency, thus ensuring that the material costs for one quality check total no more than two US$.

The GPHF-Minilab® is supplied to all interested parties willing to undertake regular efforts to monitor their drug inventories and supplies, and who are able to ensure the correct use of the laboratory.

Delivery priority is given to organizations and bodies actively involved in the public health care system of developing countries that are directly responsible for a constant supply of high-quality drugs.

Priority disease programmes from institutional development assistance are frequently using Minilabs in order to monitor the quality of medicines in malaria-, TB- and AIDS-endemic countries. Promoters and project partners are the World Health Organization (WHO) in Geneva and three major NGOs from the USA, Management Sciences for Health (MSH), the Partnership for Supply Chain Management (PFSCM) and the Drug Quality and Information programme of the United States Pharmacopeia (USP DQI), all being based in Washington DC. Support comes also from the German Technical Cooperation (GTZ) and faith-based organisations, for example, from the Medical Mission Institute Würzburg, the medicines relief organisation action medeor and the German Doctors for Developing Countries. In Tanzania, 25 Minilabs are already used as a first-line defence to protect the country's communities against the infiltration of counterfeit medicines. 

Since ten years, GPHF-Minilabs are physically and financially accessible on a global scale and are protecting health facilities around the world against the infiltration of counterfeit medicines dangerous to health and life. Over 270 units are now in place in 65 countries. Within the International Medical Product AntiCounterfeiting Taskforce (IMPACT) steered by WHO, GPHF-Minilab test methods are an accepted technology for counterfeit medicines detection and patient protection in developing countries. With this backing and a proven record in global and timely Minilab delivery to almost any destination in the world, governmental and non-governmental advisory and financing bodies, for example The World Bank, The Global Fund, UNDP etc. are able to issue grants and other support to drug quality monitoring projects using Minilabs. 

The imagination of the major funding agencies, the enthusiasm of local people, the established logistics and the commitment of the Global Pharma Health Fund will clearly take the Minilab initiative forward over the next ten years. In this scenario, training and teaching at schools of pharmacy, chemistry and medicine can be an additional option.