BOX 6-4
The Global Pharma Health Fund Minilab

The Global Pharma Health Fund Minilab is a portable drug quality analysis toolkit (Kaale et al., 2011). The Minilab was designed to help control the proliferation of substandard and falsified drugs in countries with weak or absent regulatory systems (Jähnke et al., 2001).

The Minilab relies on a combination of accessible techniques for simple, fast, and reliable detection of falsified and substandard drugs. With the exception of running water and a flat surface on which to work, the kit contains all the labware, reagents, standards for comparison, and instructions necessary to run quality tests on many common medicines. Each Minilab fits into two suitcases for durable portability. Price and simplicity guided the kit’s design; the solvents and reagents used in the assessments are safe for use with very little training and are widely available and inexpensive. Each Minilab quality test costs no more than $3 to run (GPHF, 2012c; Kaale et al., 2011).

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SOURCE: GPHF, 2012d.

The kit includes equipment and instructions for thin layer chromatography (TLC), chemical colorimetry, and disintegration tests, as well as a visual inspection protocol. Testing and inspection protocols and materials are included for more than 50 World Health Organization essential medicines, including reference standards for 63 drug compounds (GPHF, 2012a; Kaale et al., 2011). By using colorimetry, which tests for the identity of active ingredients, and TLC, which provides information about potency, the kit is capable of testing for the top three kinds of substandard and falsified drugs: those that contain no active ingredient, those that contain too little active ingredient, and those that contain the wrong active ingredient (GPHF, 2012c; Jähnke et al., 2001). Since the reliability of TLC is based in large part on the tester’s level of training, the Minilab attempts to simplify the analysis by providing reference tablets that can be used to prepare 100 percent and 80 percent dosage strengths for comparison (Kaale et al., 2011).

Currently, there are more than 500 Minilabs in 80 countries, and many prominent national and international organizations recommend the kits for field testing (GPHF, 2012c). The U.S. Pharmacopeial Convention distributes and administers trainings for Minilabs in developing countries through its Drug Quality and Information program, in collaboration with USAID (Smine and Hajjou, 2009). The lab has also been used by the WHO’s Roll Back Malaria program and by several local nongovernmental organizations in countries such as Tanzania and Ghana (Jähnke et al., 2001).

Field inspectors feed useful information about drug quality into the regulatory system. Regulators have higher-level controls to detect poor manufacturing and product quality in the market. Ultimately, no detection



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