The GPHF-Minilab® - Protection Against Counterfeit Medicines

Due to increasing counterfeit medicines proliferation and its associated health risks, drug quality control in the distribution systems of developing countries has become more and more important for consumer protection today. Africa, parts of Asia, and parts of Latin America have areas where more than 30% of the medicines on sale can be counterfeit. Other developing markets, however, have less than 10%; overall, according to the World Health Organization (WHO/IMPACT), the reasonable estimate is between 10% and 30%.

Under these circumstances, a greater number of samples have to be tested in order to maintain an appropriate assurance of drug quality and a high level of patient protection. Yet at the same time, pharmacopoeial analyses have become more and more expensive and only a few centers of excellence in some countries are currently available to perform them in the quantities required.

In order to bridge the capacity gap in regular drug quality monitoring on national level in low-income countries and in order to overcome limited access to regular drug quality testing of public, private and faith-based drug supplies, the Global Pharma Health Fund (GPHF) set out to develop and supply inexpensive field test kits with simple test methods for rapid drug quality verification and counterfeit medicines detection.

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Rapid Counterfeit Medicines Detection anywhere in the World

mlab_ziels.jpg (8337 bytes) The GPHF-Minilab takes the basic drug testing scheme published by the World Health Organization (WHO) some thirty years ago into the 21st century. New test methods have been introduced, and supplied are not only operation manuals printed in different languages, but also a complete range of lab ware, starter kit chemicals and reference standards is included - all suitably packed for global shipment by air. Now, identification of counterfeit medicines containing wrong, too little, or no ingredients at all can be performed instantly anywhere in the world. Results obtained by a set of physical and chemical screening tests must match the product label claims for, at least, drug identity and content. If they do not match or results are inconclusive, then the appropriate batches can be frozen for further investigation in a fully-fledged lab.

 

Simple Drug Quality Verification in Four Steps

mlab_qual.jpg (8165 bytes) Verifying the quality of drugs using the GPHF-Minilab® involves a four-stage test plan that employs very simple physical and chemical testing:

  1. A visual inspection scheme of solid dosage forms and associated packaging material for an early rejection of the more crudely presented counterfeits
  2. A simple tablet and capsule disintegration test in order to verify label claims on enteric-coating and other modified-release systems
  3. Simplified colour reaction tests for a quick check of any drug present, thus verifying label claims on identity
  4. Easy-to-use thin layer chromatographic tests for a quick check on drug content, thus verifying label claims on potency

 


Drug Quality Verification at Low Costs

 GPHF-Minilabs contain the essential lab ware and chemicals, as well as secondary standards for reference purposes. Supplies include sufficient quantities in order to perform about 1000 assays while ensuring that the total material costs for one test run do not exceed two Euros.

 

A Complete Laboratory in Two Suitcases

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Two heavy-duty suitcases contain the essential components - a full range of glassware for sample extraction, preparation, pipetting and spotting, high performance chromatographic plates, developing and detection chambers, UV lamps with different wavelengths, a hot plate, a spirit lamp, test tubes and calliper rules. Even pens and pencils are included.

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If needed, a digital pocket balance can easily be added. Of particular importance is a full collection of secondary reference standards for more than forty active ingredients and a set of manuals providing simple operation procedures. Written in a non-scientific format and rich in illustrations, the manuals read more like a cooking recipe than an instruction booklet. They are also available in French and Spanish.

 

Successful Operation of Minilabs

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. General support comes from the World Health Organization (WHO/IMPACT) in Geneva and two major NGOs from the USA, Management Sciences for Health (MSH RPM and SCMS Projects) and the International Technical Alliance of the United States Pharmacopeia Drug Quality and Information program (USP DQI), all being based in Washington DC.

Additional support comes 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.

Other Minilab users are, for example, British Petroleum and Rotary primary health care facilities in Papua New Guinea, public drug procurement agencies and faith-based drug supply organisations in Nicaragua and Bolivia, medicines regulation authorities in Madagascar and Zambia, consumer protection organisations in India and Pakistan, Catholic hospitals in Ghana, Cameroon and Nigeria, scientific societies and business institutions in Laos and Thailand as well as the Bill and Melinda Gates Foundation in cooperation with the London School of Hygiene and Tropical Medicine for rolling back malaria projects in Tanzania. In fact, here in Tanzania, 25 GPHF-Minilabs are already used as a first-line defence to protect the country’s communities against the infiltration of substandard quality and counterfeit medicines. Overall, more than 350 Minilabs have been supplied across 70 countries already.