Minilab number 600 supplied
Minilab number 600 just supplied to the medicines inspectorate in Angola. Building medicines testing capacity around the world since fifteen years. A sincere vote of thanks to all our partners and supporters. A lab in a box. The step from bench to population to identify fake, unsafe medicines. Vital antimalarials are life-saving, their fake and zero-content counterparts life-taking. Minilabs save lives! For full dissemination pattern see map.
Minilab training in Kenya
On behalf of its partner, the Promoting the Quality of Medicines (PQM) programme of the U.S. Pharmacopeia (USP), the GPHF carried out another five-days training on the use of Minilabs in Nairobi (Kenya) end of April. Participants were ten pharmacists from the local Pharmacy and Poisons Board (PPB) and National Quality Control Laboratory (NQCL). Training on Minilab basic tests was given by Dr. Richard Jähnke from GPHF and sampling procedures for a medicines quality monitoring study by Dr. Latifa El Hadri from USP/PQM. The range of medicines tested included antimalarial, antituberculosis and antiretroviral medicines. Overall, 67 Minilabs have been supplied to Kenya and its neighbouring countries Tanzania, Uganda, South Sudan and Somalia throughout the years, a region where the proliferation of fake drugs is known to be prominent. The training supports drug quality monitoring studies in the field in Kenya and the identification of local talents from NQCL for future Minilab South-South cooperations.
GPHF at German parliament hearing
Invited by the German parliament, the GPHF obtained the opportunity to present his work on the detection of fake medicines to the members of the Committee on Healthcare in Developing Countries. In a meeting focused on the menace of counterfeit pharmaceuticals for global healthcare, the GPHF reported his experiences with the GPHF-Minilab® used in more than 80 countries worldwide. The members of the Committee were impressed by the way the Minilab employs reliable tests for non-sophisticated medicines quality monitoring to protect people from the deadly danger of counterfeit drugs. Other experts at the hearing were representatives of Medécins Sans Frontiers, the German Ministry for Economic Cooperation and Development and the German Ministry of Health.
Counterfeit drugs and organized crime
The United Nations Office on Drugs and Crime (UNDOC) has published a report on „Transnational Organized Crime in East Asia and the Pacific” where the issue of counterfeit medicines is described as a growing part of international organized crime. The report includes a chapter on fraudulent essential medicines travelling from East Asia to Southeast Asia and Africa containing lots of information especially on the falsification of anti-malaria drugs. The full report is accessible online at the UNODC website.
Petition against counterfeit drugs
The Dutch Malaria Foundation calls to sign a petition addressed to the Governments of India and China to stop the production of counterfeit malaria drugs in their countries promptly. According to the Dutch foundation hundreds of children die in Africa every day because of fake malaria drugs, mostly produced in India and China.
GPHF-Minilab® detects counterfeits in Cameroon
Today, a press release of the German Institute for Medical Mission (DIFAEM) tells that a batch of counterfeit antimalarial drugs was detected in Cameroon using the GPHF-Minilab®. Due to a vigilant pharmacist observing that some Coartem tablets apparently had no effect, the concerned batch of Coartem was subjected to Minilab testing showing that all actives were missing. A confirmatory analysis at a fully-fledged lab of the Mission of Essential Supplies (MEDS) in Nairobi (Kenya) came to the same conclusion. The batch under investigation neither contained artemether nor lumefantrine. In recent years, DIFAEM equipped a number of local mission pharmacies in Cameroon with Minilabs for monitoring the quality of their pharmaceutical supplies. For more information, consult DIFEAM's press release unfortunately issued in German only.
Eight new test protocols for the GPHF-Minilab®
Due to the recent extension of its method inventory, the GPHF-Minilab® holds now 72 test protocols ready for drug identity and drug content verification on 63 active pharmaceutical ingredients including their most common fixed-dose combinations. The new test protocols are focusing on antituberculosis and other antibacterial medicines. Demo versions of the latest extension with all details on the active ingredients involved can now be accessed in English, French and Spanish. The latest Minilab supplement is published jointly with the Promoting the Quality of Medicines programme maintained by the U. S. Pharmacopeia and the United States Agency for International Development. The number of Minilabs supplied approaches 600 units based in 80 countries. Here, they help developing nations in boosting their medicines testing capacity to protect people from the danger of counterfeit medicines.
INTERPOL and pharmaceutical industry launch global initiative to combat fake medicines
Combating the global scourge of fake medicines which threatens the health of millions of people is the focus of a landmark agreement between INTERPOL and 29 of the world’s largest pharmaceutical companies. The three-year deal, worth EUR 4.5 million, will see the creation of INTERPOL’s Pharmaceutical Crime Programme to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit. This will enhance the law enforcement community’s response to pharmaceutical crime through stronger partnership development. The programme will focus on the prevention of all types of pharmaceutical crime including branded and generic drug counterfeiting as well as the identification and dismantling of organized crime networks linked to this illegal activity, which generates millions in illicit profits every year. For more information please go to www.interpol.int.
Most Successful year in the history of the GPHF
The Global Pharma Health Fund (GPHF), a Frankfurt based non-profit organization, is able to look back on one of his most successful years in project history. During the general meeting this year February, chairman Frank Gotthardt said that overall 100 GPHF-Minilabs were disseminated in 2012 to detect falsified medicines, for example, 40 of them went to Vietnam and 10 more to Angola. GPHF-Minilabs have been and are being used in 86 countries around the world today. Gotthardt announced that the GPHF will go on to extend the Minilab’s method inventory to increase its range of applications even further.
Myanmar: Donation of three GPHF-Minilabs
Dr. Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, now handed over three GPHF-Minilabs to the representatives of the Ministry of Health in Myanmar. Kley visited the country during a business trip to Southeast Asia. The three mobil units will be part of a local programme to promote the quality of the medicines in the country formally known as Birma. The program is run by the World Health Organization and the United States Pharmacopoeia in cooperation with the Myanmar ministry of health since 2012. The Minilabs (amounting to about 19.000 USD) are a charitable donation by Merck Singapore.
WHO: Roadmap To Fight Poor Quality Medicines
The first meeting of the World Health Organization (WHO) mechanism intended to promote the prevention and control of “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products, held in Buenos Aires (Argentina) last week, is being called a success. Member states agreed on a work plan that focuses on strengthening regulatory capacities and decided to form a steering committee to monitor country compliance to the plan.
Officials and experts from 76 countries launched a road map to combat the counterfeiting of medications, a global public health problem that demands a joint response. The mechanism will focus on strengthening regulatory capacities and increasing cooperation between drug authorities in order to prevent and control poor quality medicines. Additionally, the mechanism will seek to identify the activities and behaviours that drive the propagation of poor quality medicines across the globe.
“Drug counterfeiting causes death and disease, regardless of gender or age. It is an international public health problem,” said Argentina’s Minister of Health, Juan Manzur, during the opening of the meeting.
Africa: Millions of counterfeit drugs detected
The World Costums Organization (WCO) in Brussels has now announced that an operation spanning 16 African countries led to the seizure of more than 82 million doses of illicit medicines including antimalarial and antiparasitic drugs, antibiotics, cough syrups, and even contraceptive pills and infertility treatments, estimated to be worth over 40 million US dollars.
The operation was conducted simultaneously at 16 major seaports on the East and West coasts of Africa from 11 to 20 July 2012, leading to the seizure of more than 100 million counterfeit products of all categories. Of a total number of 110 sea containers inspected by teams of Customs officials, 84 were found to contain counterfeit or illicit products, with the biggest shipments being discovered in Angola, Togo, Cameroon and Ghana. The vast majority of shipments seized originated from South and East Asia and the Middle East
The operation was organized by the WCO in partnership with the Institute of Research against Counterfeit Medicines (IRACM). These results are alarming and serve as a reminder of the scale of the traffic in illicit medicines in Africa and the danger this illicit trade represents to consumer health and safety.
Minilab now capable of testing all antimalarial co-formulations based on artesunate
Spurious, counterfeit and substandard quality medicines are a global problem which have a highly negative impact on public health and patient safety. In developing countries, subpotent falsified antimalarials even foster the development of drug resistant parasites. Seen as a new way forward to treat Malaria, it now appeared necessary to add artesunate-based co-formulations to the list of antimalarials already existing in the Minilab’s method inventory for the detection of unsafe counterfeit anti-infective medicines. This will allow to include artesunate for testing in due diligence stock control and post-marketing surveillance studies even when combined with amodiaquine, mefloquine, pyronaridine, sulfadoxine and sulfamethoxypyrazine. Adding these new co-formulations has been made possible without changing the Minilab’s technical platform. With the new extension in hand, the current Minilab method inventory covers 58 active pharmaceutical ingredients allowing to verify the quality on an amplitude of finished drug products. Virtually all major antimalarials are now included. The new Minilab supplement is published jointly with the Promoting the Quality of Medicines (PQM) programme maintained by the US Pharmacopeia (USP) and US Agency for International Development (USAID). GPHF-Minilabs have been supplied over 500 times to more than 80 countries across Africa, Asia and Latin America already. Malaria affects 106 countries, half of the world population are at risk
Counterfeit antimalarial tablets detected in Congo
Recently, the German Institute of Medical Mission (DIFÄM) informed its partner organisations about the existence of counterfeit quinine tablets detected in the Democratic Republic of Congo. All declarations on the label had been forged, for example, source, content and batch number. The label pretends that the tablets were manufactured by Shelys in Dar es Salaam (Tanzania) but the batch number 880 is not on their records. Minilab assays proved the almost complete absence of quinine and the existence of an unknown compound. As the counterfeit tablets are associated with failed malaria treatments including death of patients, it is also assumed that the tablets did not contain any antimalarial drug. In the meantime, the fake products have been taken from the shelves and all stakeholders, for example, local drug authorities, the World Health Organization and members of the Ecumenical Pharmaceutical Network have been informed about the fatal product. A second case of counterfeit antimalarial tablets, again with zero quinine content, has been detected by some other Minilab users in Africa throughout the summer. Investigations are pending, one person has been jailed already. Both cases prove the importance of regular post-marketing drug quality testing and the use of simple and affordable thin layer chromatography for the detection of unsafe bogus medicines in particular in places and countries where strong drug regulatory authorities and fully-fledged drug testing labs are missing.
GPHF trains experts from Indonesia at Merck Darmstadt to recognize fake medicines
To complete existing efforts in post-marketing drug quality monitoring including risk assessment of counterfeit and substandard medicines in Indonesia, three governmental pharmacists from Jakarta arrived for a five-days Minilab workshop at Merck Darmstadt Monday last week. The workshop included also a trip to the pharmaceutical crime unit of Germany’s Federal Criminal Police Office in Wiesbaden. The training focused on the detection of falsified anti-infective medicines for high priority disease programmes, for example Malaria, TB and HIV/AIDS. Frequently coming in sub-therapeutic doses, fake anti-infectives are not curing diseases and are promoting the formation of drug-resistant strains. The production and dissemination of them being outright criminal practice. Over the recent years, the Minilab of the Global Pharma Health Fund (GPHF), a charity maintained by Merck Darmstadt, gradually became an important element in post-marketing surveillance studies helping in analysing the status quo of drug quality for a range of anti-infective medicines and ensuring that patients and the general public are not exposed to non-effective counterfeit medicines.
Indonesia: TB medicines quality study using Minilab and compendial tests
With support from the Indonesia Mission of the United States Agency for International Development (USAID), two training workshops on the ‘Quality Analysis of Anti-Tuberculosis Medicines’ were performed by the Promoting the Quality of Medicines (PQM) programme from the United States Pharmacopeia (USP) and the Global Pharma Health Fund (GPHF) at the National Quality Control Laboratory for Drug and Food in Jakarta in the second week of June. One workshop was focussing on sophisticated compendial drug analysis, for example liquid chromatography and dissolution testing, where as the other was more concerned about basic medicines testing using GPHF’s Minilab. Both organisations, USP and GPHF, brought in their experts to train thirty three member of staff recruited from governmental labs from East and West Java, South Sulawesi, North Sumatra, West Nusa Tenggara next to Bali and the national drug quality control lab itself. Indonesia rates as high burden tuberculosis country and in face of multi-drug resistance that challenges the Indonesian Government as a whole and the National Agency of Drug and Food Control in particular to do more to support and improve the good manufacturing practices compliance and monitor the quality and access to anti-tuberculosis medicines to support the National TB Control programme efforts in fighting the disease.
Myanmar: After long years of waiting, now green light for Minilabs
Isolated for decades by sanctions imposed over human rights concerns, Myanmar has become one of the poorest countries in Southeast Asia today. Since last year, the military junta gently opened the way for political and economic reforms and started an unprecedented engagement with the West. US, EU and Asian statesmen are queuing now to shake hands as firms are seeking a share of Myanmar’s vast untapped natural resources. Much further down this path green light has been given also for the use of Minilabs in order to support the ongoing collaboration of the World Health Organization (WHO) with national health departments in rolling out the Myanmar Artemisinin Resistance Containment project. As an emergency response project to the rapid spreading of artemisinin drug resistant Malaria alongside the Thai-Burmese border, one of the key intervention is boosting the national capacity in monitoring the quality of antimalarial drugs and the detection of pseudo-resistance based on substandard and counterfeit products circulating in the market. For this, the Ministry of Health agreed on a range of training workshops for well over thirty member of staff at Myanmar’s new capital Nay Pyi Taw onset May. For the establishment of a medicines quality monitoring system including sampling, testing and reporting procedures, the WHO country office in Myanmar asked the Promoting the Quality of Medicines programme (PQM) for assistance. For the part of basic testing, PQM sought the expertise of the Global Pharma Health Fund and its Minilab, a self-contained mini-laboratory designed for the detection of harmful counterfeit medicines with a high sample throughput at low cost. Five of these Minilabs will support the forthcoming base-line survey on the quality of priority antimalarial medicines in those five states of Myanmar bordering Thailand. They include the former rebel ridden states of the Mons and Kachins. All the work is funded by the U.S. Agency for International Development (USAID).
Cambodia: Minilabs great scout in the identification of counterfeit medicines
Detecting counterfeit antimalarial and other antiinfective medicines, 19 Minilabs are serving their important duty in Cambodia since many years already. In recognition of their vital role, their capacity in combating harmful counterfeit medicines has again been demonstrated by the Mekong project of the Priority Solidarity Fund in Pailin city in Cambodia next to the Thai border last month. The Minilab demonstration is part of a continuing education on product piracy performed by Cambodia’s ministry of internal affairs for police and customs forces, health authorities and other governmental departments.
Africa: Ecumenical unity to combat counterfeit medicines using Minilabs
The German Institute for Medical Mission in Tübingen (DIFÄM) drives the establishment of Minilabs to avoid using fake or substandard quality medicines at faith-based drug supply organisations in Cameroon, Ghana and Malawi. The first Minilab arrived at the health facilities of the Baptist Convention in Cameroon already last year and now a second Minilab arrived in Cameroon for use at the health service centre of the Presbyterian Church in Limbe. Trainings will be held at each Minilab site, the one in Limbe just finished. Appropriate pictures are shown here. All Minilab users are members of the Ecumenical Pharmaceutical Network (EPN) which will facilitate the exchange of information on drug quality data generated with the Minilabs.
Russia: TB medicines quality monitoring using Minilabs
Following the three TB clinics identified as Minilab sites in 2009, six more sites have joined the TB medicine quality monitoring programme till now. Based on TB prevalence data and the availability of qualified staff, the sites for rapid TB drug quality testing have been identified by Russia’s Federal Service on Surveillance in Healthcare and Social Development (Roszdravnador) together with the local offices of the US Agency for International Development, the World Health Organisation’s TB Control programme, the International Federation of Red Cross and Red Crescent Societies and Partners in Health. The sites are based in the cities of Moscow, St. Petersburg, Oryol, Vladimir, Belgorod, Rostov, Novosibirsk and Tomsk of West and Central Russia. The management of drug sampling, Minilab handling, testing and reporting is the responsibility of the TB institutes and dispensaries in these cities for which a central Minilab training has been conducted jointly by the US Pharmacopeia’s Promoting the Quality of Medicines programme and the Global Pharma Health Fund in Moscow last week. Russia is one of 22 countries with a high burden of tuberculosis and eleventh on the WHO list of TB endemic countries. Tuberculosis effects more than 120,000 Russians each year, and the impact is now compounded by an increased concern about multi drug-resistant tuberculosis, gradually turning into extreme drug-resistant TB if not treated properly with appropriate medicines of high quality.
Fake miltefosine in Bangladesh: researchers stress the need for simple assays
Falsified versions of generic miltefosine capsules for the treatment of visceral leishmaniasis (black fever), a fatal parasitic disease, were administered to hundreds of patients in Bangladesh in 2008. After Dutch doctors uncovered the case, samples were sent to the University of Amsterdam where the complete absence of miltefosine was finally confirmed using complex fully-fledged spectrometric analytical techniques. The results of the lengthy lab work have now been published in the “Analyst”, a journal from the Royal Society of Chemistry. The authors conclude that the “finding of a suspected counterfeit drug intended to treat a neglected disease in a resource-poor country emphasizes the urgent need to develop more simple inexpensive assays to evaluate drug quality for use in the field.” This is exactly the reason the Minilab of the Global Pharma Health Fund (GPHF) has been invented for and the experience made by the researchers in Amsterdam will be shared with GPHF for future method developments. Leishmaniasis is spread by the sand fly and is the world's second worst parasitic killer after malaria. It affects 500,000 people, killing about 50-60,000 patients per year.
Fake medicines: any time, any place, any product
The proliferation of false medications continues. The findings from 2011 show again that the falsification of medicines affects all types of products, be they generic or innovator, occurs across the globe and threatens the health of patients. Case reports include the counterfeiting of antimalarials and the commercialisation of poor and extreme poor quality medicines. Combating the harmful trade is ongoing. For example, Operation Cobra in the West African region and Operation Pangea searching the Internet. Both operations masterminded by Interpol. As counterfeit medicines may not contain any active ingredient or are subpotent, the need for more Minilabs remained high in 2011, too. On average, six to seven Minilabs were sent into overseas projects each month, for example Liberia, Cameroon and Papua New Guinea. Overall, 474 Minlabs have now been delivered to over 80 countries. Supported by the Promoting the Quality of Medicines (USP/PQM) programme, the Minilab’s method inventory has been extended again, now covering 57 active pharmaceutical ingredients, the bulk of them being used as priority essential medicines to treat Malaria and Tuberculosis. For 2012, another supplement is scheduled. It will cover more vital anti-infective drugs.
250th Minilab delivered to Africa
From 470 Minilabs delivered globally, 250 went to Africa and the jubilee Minilab was received by the health department of the Presbyterian Church in Cameroon (PCC) today. Consisting of overall 54 nations, health facilities from 35 African countries adopted the Minilab so far; a field test kit developed for a rapid, non-sophisticated physical and chemical screening on harmful counterfeit medicines containing to much, to little or no drug at all. All 35 countries are from the Sub-Saharan region and a group of five countries obtained 50% of all labs. These countries are Nigeria, Ghana, Tanzania, Madagascar and the Democratic Republic of Congo, all with a high burden but also high awareness of false medications floating the markets in Africa and elsewhere. Projects for the North African region need still to be identified. Next to national health authorities, private corporations and the Global Pharma Health Fund (GPHF), past and current sponsors are international health assistance facilities, for example, from the United Nations family (UNICEF, UNODC, WHO, RBM), the Global Fund (AMFm), the United States (USP, MSH), Great Britain (MeTA, PATHS2), Switzerland (SCIH, INESS), Belgium (BTC) and Germany (GIZ). Faith-based organisations from the Netherlands (CordAid) and Germany (DIFÄM, MMI , Medeor) are procuring GPHF-Minilabs frequently on behalf of the Ecumenical Pharmaceutical Network (EPN) for own health services and partner hospitals as beneficiaries in Africa. The one for Cameroon came actually from them.
Without Scruples: thriller on the fatal trade in counterfeit medicines
Most of us may be unaware that people are dying due to some unscrupulous human beings faking anti-infective medicines. But if you go to villages in Ghana, Kenya or Cambodia you will learn about the constant worries of the parents that their child might be next. Build on this background, Ingrid Glomp’s thriller “Without Scruple” is a fascinating insight story of a journalist in the search for answers on where counterfeit medicines are produced, how they are traded and who is taking the profits. The story starts in Frankfurt when a banker is dropping from a tower block. Journalist Cori Stein is the direct witness and by chance obtains a little piece of evidence. Dreaming of a cover story, followed by a killer, protected by a friend, she now starts to travel almost all continents. For example, on a stop in Nigeria, she meets the Minister of Health having once survived an assassination attempt after raiding the markets and seizing counterfeit medicines. Later, upcountry, Cori enjoys seeing one of the many undercover Minilabs used by local health authorities for the detection of spurious antibiotics. A quick test will actually help in saving little Joe’s life. But to meet the guys behind the crime, she has to move on to China and Russia. Fit for a new James Bond film and coming with a happy end, the book will surely make a nice reading during the forthcoming Christmas break. Available in German only. Translation pending.
Ghana: Securing medicines quality through routine use of Minilabs
Counterfeit and substandard quality drugs are a serious problem across the globe and capacities to deal with them are limited in particular in developing countries. In Ghana, for example, several cases of falsified antimalarial medicines with zero drug content have been reported in the recent years. Consequently, its medicine regulatory mechanisms incorporate quality assurance during registration and post market surveillance but counterfeiters and grey importers of substandard medicines use unofficial channels to outwit the existing system. In this context, Ghana’s Food and Drugs Board (FDB) uses GPHF-Minilabs for routine drug quality testing with fully-fledged confirmation analysis to improve post marketing monitoring. Market monitoring is funded by the Medicines Transparency Alliance (MeTA) and till to date, two rounds of antibacterial, anthelminthic and antidiabetic drug testing have been conducted, the results of them being shown here.