The GPHF-Minilab™ - Protection Against Counterfeit Medicines

1. The GPHF-Minilab™
Protection Against Counterfeit Medicines
Postgraduate Department of Pharmacology
Government Medical College, Srinagar

2. THE GLOBAL PHARMA HEALTH
FUND (GPHF)
 The Global Pharma Health Fund (GPHF) is a charitable organization
initiated and funded exclusively by donations from Merck Germany.
 Promoters and project partners are major NGOs from the US, for
example Management Sciences for Health (MSH) and the Promoting the
Quality of Medicines programme of the United States Pharmacopeia
(USP PQM).
 Support comes also from the German Agency for International
Cooperation (GIZ) and faith-based organisations (Medical Mission
Institute Würzburg, the medicines relief organisation action
medeor and the German Doctors for Developing Countries).
 The project is managed by Dr. Richard W. O. Jähnke, a qualified
manufacturing pharmacist with a master in business administration.
He coordinates GPHF-Minilab™ development and implementation, and
responses to information and training requests.

3. GPHF-Minilab™
 The GPHF-Minilab™ is a mobile mini-laboratory that allows quick, reliable testing
of 90 active ingredients.
 Showing whether or not the right drug in the right quantity is present in the
appropriate single and fixed-dose combination products.
 The toolbox has been specifically designed for use in developing countries that are
heavily affected by counterfeit medicines and are lacking the facilities for
effective medicine testing.
 More than 800 Minilabs have been supplied to health facilities across 97 countries
already (15 in India).
 According to the latest research from the WHO, 1 in 10 medical products circulating
in developing countries is either substandard or falsified.
 Pharmacopoeial analyses is very expensive and only a few centers of excellence in
some countries are currently available to perform them in the quantities required.
 in order to overcome limited access to regular drug quality testing. GPHF set out
to develop and supply inexpensive field test kits with simple test methods for
rapid drug quality verification and counterfeit medicines detection.
 The GPHF-Minilab takes the basic drug testing scheme published by WHO some thirty
years ago into the 21st century.
 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.
 http://www.who.int/medicines/regulation/ssffc/publications/GSMS_Report.pdf?ua=1. Accessed June 20, 2018.

4. Simple Drug Quality Verification in Three Steps
Verifying the quality of drugs using the GPHF-Minilab™ involves a three-stage
test plan that employs very simple physical and chemical testing:
1. A physical inspection scheme of 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. Easy-to-use thin layer chromatographic tests for a quick
check on drug content, thus verifying label claims on
potency
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.

5. A Complete Laboratory in One Suitcase
 A heavy-duty suitcase contains the essential components - a
full range of glassware for sample extraction, preparation,
pipetting and spotting, high performance chromatographic
plates, developing and detection chambers, electronic pocket
balance, UV lamps with different wavelengths, a hot plate and
calliper rules. Even pens and pencils are included.
 Of particular importance is a full collection of secondary
reference standards for currently 90 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.

6. Working Principle
 Physical Testing: Visual
Inspection Guide &
Disintegration Test.
 Chemical Testing: Thin Layer
Chromatography.
 Can be used outside a
laboratory environment by those
having some understanding of
analytical chemistry, for
example medical or
pharmaceutical technicians.
 90 compounds taking into
account medicines prevailing in
developing countries for
priority diseases and mother &
childcare.
 Total Weight: About 50 kg as
ready-packed palette for
worldwide delivery by air.
 Shelf Life: About 2 years for
authentic secondary reference
standards. May be shorter for
antiretrovirals.

7. Ref. Standards
23 antimicrobials
 amoxicillin, ampicillin, azithromycin,
benzylpenicillin potassium, cefalexin,
cefazolin, cefixime, ceftriaxone,
cefuroxime, cefpodoxime, ciprofloxacin,
clarithromycin, clavulanic acid,
doxycycline, erythromycin, gentamicin,
levofloxacin, metronidazole, ofloxacin,
phenoxymethylpenicillin,
sulfamethoxazole, trimethoprim and
tetracycline , chloramphenicol and
cloxacillin.
6 cardiovascular drugs:
 amlodipine, atenolol, bisoprolol,
captopril, furosemide and
hydrochl.orothiazide.
16 anti-TB drugs
 4-aminosalicylic acid (PAS),
ciprofloxacin, cycloserine, ethambutol,
ethionamide, isoniazid, kanamycin,
levofloxacin, moxifloxacin, ofloxacin,
prothionamide, pyrazinamide, rifampicin,
amikacin disulfate, capreomycin
disulfate and streptomycin
hemitrisulfate
9 antiasthmatics, antiallergics and
analgesics:
 acetylsalicylic acid, aminophylline,
cetirizine, chlorphenamine, diclofenac,
mefenamic acid, naproxen, paracetamol
and prednisolone.
3 other anti-infective and antiseptic
medicines:
 chlorhexidine, dapsone and griseofulvin
3 anthelminthics:
 albendazole, mebendazole and praziquantel
.
12 antimalarials:
3 other medicines:
 clomifene, glibenclamid and metformin
Optional items also:
 6 antiretrovirals: efavirenz,
indinavir, lamivudine, nevirapine,
stavudine and zidovudine

8. Active Pharmaceutical Ingredients, Co-Formulations,
Dosage Forms (Injectables)
 Amikacin single drug powders and solutions for injection.
 Artesunate single drug powders for injection.
 Benzylpenicillin benzathine single drug powders for injection.
 Benzylpenicillin procaine single drug powders for injection.
 Benzylpenicillin procaine and sodium co-formulated (fortified)
powders for injection
 Benzylpenicillin sodium/potassium single drug powders for
injection
 Benzylpenicillin sodium and procaine co-formulated (fortified)
powders for injection.
 Capreomycin single drug powders for injection.
 Cefazolin single drug powders for injection.
 Ceftriaxone single drug powders for injection.
 Diclofenac sodium single drug injections
 Diclofenac sodium in co-formulated lidocaine injections.
 Gentamicin sulphate single drug solutions for injection.
 Kanamycin monosulfate single drug in powder for injections.
 Streptomycin single drug powders for injection

9. Drugs covered in Hospital supply
 Albendazole single drug tablets and capsules.
 Amikacin single drug powders and solutions for injection.
 Amoxicillin trihydrate single drug tablets and capsules.
 Cefixime single drug tablets and capsules
 Ceftriaxone single drug powders for injection.
 Cefpodoxime proxetil single drug tablets and capsules.
 Ciprofloxacin hydrochloride single drug tablets and capsules.
 Diclofenac sodium single drug injection.
 Gentamicin sulphate single drug solutions for injection.
 Levofloxacin single drug tablets and caps.
 Ofloxacin single drug tablets and capsules
 Oseltamivir single drug tablets and capsules.
 Paracetamol single drug tablets and capsules.
 Prednisolone single drug tablets and capsuels.