Afghanistan's Pharmaceutical Situation Mohammad Bashaar Kabul, Afghanistan March, 2009
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Health and Pharmacy System in Afghanistan
Pharmaceuticals are an important part of health-care expenditure in Afghanistan, however during civil war and conflict the Afghanistan pharmaceutical system has partially collapsed. According to official statistics, Afghanistan has approximately 5,640 doctors servicing about 28 million people. Even though there is one doctor for every 4,964 persons, most of the population are based in the cities, and typically it is the untrained health workers who dispense medicines in the villages1. The Faculty of Pharmacy has been the only one in the country for 50 years2. The Faculty of Pharmacy has five departments including Pharmacognosy, Pharmacology, Pharmaceutical Chemistry, Pharmaceutics, Biochemistry and Food Analysis. It has seven functioning laboratories and recently a new curriculum has been approved. An estimated 400 students are enrolled with the Faculty of Pharmacy.
The Afghan Pharmaceutical System
Afghanistan imports all the medicines it needs. Most of the medicines originate from Pakistan, Iran, China and India. Since 2005 the government has had a list of 1,270 approved medicines, including essential drugs, dispensary items and dental preparations. It lists 27 over-the-counter medicines and 42 controlled drugs (narcotic and psychotropic substances). The Pharmaceutical department carries out unscheduled checks on drug stores but cannot control the spread of fake, expired or substandard medicines.
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There has been a dramatic increase in the amount of donated medicines reaching Afghanistan since 2002. It is estimated that medicines donated in kind or bought with donated money make up between 20 and 30 percent of pharmaceuticals used in Afghanistan. The remaining 70 to 80 percent of pharmaceuticals not supplied by donors are on account of the private sector. On the basis of a population of 25 million, the
private pharmaceuticals market in Afghanistan could be worth up to US$200m per year. The Afghanistan statistical yearbook from 1998–2003 shows the following imports of pharmaceuticals (figure 1). It is difficult to record the current size of the private sector pharmaceuticals market, as many importers and wholesalers are unregistered1. Smuggling is a significant concern in the pharmaceuticals sector. Both patent and generic medicines are sold on the Afghan market. There may be up to 5,000 different items in the private pharmaceuticals market in Afghanistan.
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Afghanistan is surrounded by countries that are established manufacturers of medicines, such as India, Iran and Pakistan, and it is unlikely that domestic production will ever eliminate a reliance on importation. Afghanistan also lacks its own chemical industry to produce active raw ingredients for medicines. Nonetheless, there is room in the Afghan market for the development of larger scale domestic production to partially substitute imports with affordable, good quality Afghan-made products and to benefit the Afghan economy by promoting Afghan manufacturing. Main Players in the Afghan Private Pharmaceuticals Market History of Pharmaceuticals Production
Before 1992, there was a developed production capacity in Afghanistan and those pharmaceuticals that were imported from abroad mostly came through the Ministry of Public Health (MoPH) and specifically through the state-owned enterprise Avicenna Pharmaceutical Institute, which kept pharmaceuticals in stock and distributed them to the provinces2. During
the eighties and early nineties there were few licensed private
importers, however in Mujaheddin controlled areas drugs were imported from Pakistan and Iran. When the government system began to collapse in the early nineties, private individuals came to dominate pharmaceuticals imports. Pharmaceuticals from Pakistan were particularly popular, and their import was aided by the large number of Afghan refugees in Pakistan. Medicines are now imported into Afghanistan via various routes, including; Europe, India, China, Southeast Asia, Iran, Pakistan and the Middle East.
From the 1970’s until the end of the Najibullah period in 1992, Afghanistan was a manufacturer of medicines. As one article has noted, “Only a decade ago, Afghanistan
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was producing the majority of its medicine inside the country and was even developing an export market.”
Following is an outline of a few Afghan Companies Pharmaceutical manufacturers
Hochpharma The German Hoechst Corporation (now Sanofi-Aventis Corporation) opened a factory in Kabul in 1968, in which the government had a 51% stake. During its peak-day, the Hoechst plant produced some 130 types of medicine, covering a wide range of Afghan domestic needs. In 1991 the German partners withdrew all of their representatives and in 1997 stopped formal production, however, there has been some small-scale production on the site since then. In August 2005 the Hoechst Afghanistan AG finally became privatized and in October 2005, Hochpharma started production of generic drugs, including painkillers, anti-depressants, blood pressure medicines, gynecological medicines and antibiotics. The name was then changed to Hochpharma Corporation. The MoPH holds a 15% stake and foreign private investors hold an 85% stake in the Corporation. Hochpharma is receiving technical assistance in quality control and production procedures by Sanofi- Aventis Corporation2.
Avicenna Pharmaceutical Institute (API)
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Avicenna Pharmaceutical Institute (API) was established in the 1970’s. It is situated in Kabul and there has been some reconstruction of buildings and machinery after physical damage and looting during the conflict period. API is on the list of state-owned enterprises to be privatized in Afghanistan. Along with importing pharmaceuticals, licensing and monitoring private sector imports, API also previously produced around 120 different types of pharmaceuticals. This production capacity was severely hampered by the conflict and recently the institute is producing only iodine antiseptic and its future as a manufacturing centre is under review. It is a branch of the Department for Pharmaceuticals in the MoPH, but is self sufficient in financial terms. Avicenna is also responsible for granting licenses to importers throughout Afghanistan. American Afghan United Incorporated (AAUI)
American Afghan United Incorporated (AAUI) Pharmaceuticals is a new factory in Kabul with 100 percent private, foreign ownership. AAUI plans a total investment of US$2–5m in machinery, such as a tablet-making machine with a capacity of 100,000 tablets per day, which has already been installed at the site. The company plans to produce antibiotics, analgesics and other generic medicines, beginning with seven different products, designed entirely for sale on the local market as high-quality and affordable substitutes for imported products. Baz International Pharmaceutical Company Ltd
Another private–public pharmaceuticals venture in Afghanistan is the Baz International Pharmaceutical Company Lt. This Company is the result of a project launched in 2002 by the Swiss non-profit organization, Business Humanitarian Forum, the Brussels-based
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European Generic Medicines Association (EGA) and the United Nations Development Programme Country Office in Afghanistan. Other registered manufacturers
Other than the above mentioned companies, there are six registered 100% Afghan-owned pharmaceutical production sites in Kabul. Most pharmaceutical producers are Kabulbased, but there are some producers based in provincial cities some of whom may not be registered with the authorities. The producers who were interviewed had been in business for between 10 months and four years. Most were operating on a small scale, and manufactured a similar range of products, such as cough syrups, antacid syrups, multi vitamin syrups, antiseptic and anti-inflammatory ointments and powders such as talcum powder. One manufacturer had a contract with an international NGO operating in the health sector to produce chlorine, which was then distributed by the NGO across the country. These factories employed between 5 and 60 staff, of which between one and six were qualified pharmacists. In one case, some members of the staff had been sent to a neighboring country for training.
Most manufacturers said they planned to begin producing more products such as antibiotics, but factories have constraints such as electricity shortages and lack of access to land or secure accommodation. Manufacturers are also hampered by the fact that all machinery and raw materials must be imported into Afghanistan. Technology used to produce medicines must also be cleared by the MoPH and can therefore be retained by Customs for some time. Producers are unable to secure contracts with large European producers for raw ingredients as the size of their orders are too small. These raw
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materials, especially the active pharmaceutical ingredients for pharmaceuticals, are subject to testing by the MoPH after import. In these circumstances, Afghan manufacturers have to compete with imported medicines, especially smuggled and cheap, low quality imports. Foreign entrepreneurs who are already in Afghanistan attempting to set up businesses have difficulties such as security, lack of infrastructure and banking systems and cumbersome bureaucratic process. Importers and wholesalers
Importers of pharmaceuticals must register with the MoPH- some 200 importers of pharmaceuticals are currently registered. Importers provide the MoPH with a form listing the medicines they intend to import and this is compared to the list of permitted medicines before being approved. This list must show that the pharmaceuticals for import are manufactured by companies registered with the MoPH. Importers may sell to wholesalers, but the majority of importers also have their own wholesale operation. Wholesalers also require a license from the MoPH and must have a qualified pharmacist on their staff. Import enterprises are often often referred to as “private limited” limited” pharmaceutical companies. Importers of regular and larger scale consignments of medicines either have an agreement with a foreign manufacturer or make regular visits to wholesale markets abroad, particularly in Pakistan. Importers and wholesale operations tend to specialize in pharmaceuticals from one location, so one importer might bring Indian medicines and another might bring Korean, Iranian or Pakistani Pa kistani medicines.
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Wholesalers and importers have several years of experience in the pharmaceutical business, ranging from 5 to 26 years with various backgrounds. Some appeared to have started in this business after losing their jobs as government employees at the end of the Najibullah regime in 1992. Some were previously health care professionals who could not make a sufficient wage as doctors, and some previously owned pharmacies and extended into the import business. It is likely that a number of the larger scale importers are not registered with the authorities and do not bring their products through customs or MoPH procedures. Smugglers
Most of Afghanistan's 930-kilometre border with Iran and the 2,240-kilometre border with Pakistan are scantily patrolled and largely porous. This has allowed “practically anyone” to bring medicines into the country, especially before 2002. The smuggling is also decentralized in the sense that individuals going across the borders for different reasons are given lists of medicines to bring back by the pharmacies. Different medicines available on the market (as compared to what is being registered with the MOPH) in Afghanistan testifies the scale of smuggling occurring in this sector. The number of brands and types on the market far exceeds the number of registered medicines and thought to be between 1,100 and 1,200 in total. There are donated medicines to be found on sale by private pharmaceutical retailers, indicating that there is some degree of “leakage” of donated medicines onto the private market. In addition, there are anecdotal reports that medicines donated for Afghanistan are exported for sale in the neighboring countries.
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Pharmacies
Afghanistan has both private and government owned pharmacies. Government pharmacies are sometimes known as API pharmacies. These were previously supplied by API until the latter lost much of its production and importing capacity during the conflict period. Hospitals and clinics in Afghanistan have pharmacies that are supplied by donors, the MoPH or Non-Government Organisations (NGOs) operating in the health sector. Government pharmacies are now only partly supplied by the MoPH. All government pharmacies buy medicines from importers and wholesalers on the local market. Some were supplied 70 percent by the MoPH and 30 percent from importers and wholesalers on the local market; others said they received only 30 percent from the MoPH. Staff at these pharmacies is technically MoPH employees but they receive no salary, and make an income from the business of the pharmacy. Some staff reported that they took a 50 percent share of the profits made by the government pharmacy. There are around 13,000 licensed private pharmacies in Afghanistan, and it appears that these proliferated during the Taliban period, during which licenses were handed out liberally. Pharmacies should technically be a certain distance apart from each other, but a drive around any Afghan city shows that this rule is not in practice.
Pharmacy owners do not need to be qualified pharmacists, but a pharmacist should be in attendance at all times during opening hours. However this is not always followed. Several pharmacies displayed MoPH lists of regulations for pharmacies but many of them not have a pharmacist on duty. Researchers were told by a qualified pharmacist and
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pharmacy owner in Herat that he knew of no other pharmacy in the area that had a trained pharmacist on duty. It was also found that in Mazar-e-Sharif there is a recent initiative to train nurses to work in pharmacies.
Pharmacies buy medicines from wholesalers, directly from importers, or through “agents”. For example, one pharmacy owner said he employed agents to travel to Kandahar and Herat to buy pharmaceuticals from wholesalers. Most pharmacies reported good profits, but high rents and an insecurity of tenure was a common problem. Pharmacies are often concentrated in areas near hospitals or clinics, both public and private. Many doctors in private clinics are thought to own pharmacies or patronize a particular pharmacy owned by a business contact with which they have a mutually beneficial agreement. Doctors can either direct their patients to a particular pharmacy or can write prescriptions in such a way as to be comprehensible only to the pharmacy with which they had a business arrangement. It is thought that doctors sometimes import medicines themselves for sale in their own pharmacies.
Access to pharmaceuticals in the districts comes from public sector health care centers, private clinics and pharmacies and general grocery stores that also sell medicines. The link between private doctors and clinics and private pharmacies was even more evident in the districts than in urban areas. In the districts pharmacies were sometimes clearly owned and co-located with private clinics. The prices of pharmaceuticals available at the district pharmacies were similar to the ones available in the provincial capital, and pharmacy owners reported that they bought the products from wholesalers in Kabul.
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Pharmaceuticals may be scarce and possibly more expensive in the remote areas. In small communities, it appeared that the sale of pharmaceuticals on credit was common. In one district in Herat Province, a pharmacist and private doctor showed a log book with long lists of unpaid debts of community members who had not been able to pay for their purchases. Based on an estimation of Afghan Ministry of Public Health (MoPH) below are the numbers of pharmacies in various provinces. Province
No. of Pharmacy Outlets
Kabul
2387
Herat
729
Nangarhar
741
Kandahar
356
Balkh
571
Bamyan
28
Takhar
199
Kapisa
187
Baghlan
287
Jawzjan
180
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Street vendors, grocery stores
Pharmacies are not the only retail outlets selling pharmaceuticals in Afghanistan. Grocery stores selling basic foodstuffs also often sell medicines. Medicines are also commonly available on the street, sold by street vendors who congregate in busy street markets and sell a variety of medicines by blister strip. The medicines are often bought from pharmacies or wholesalers. Street vendors in Kabul, who typically congregate in one area of town, told researchers that they could advise the appropriate medicine for headache or other pain, diarrhea and respiratory illnesses. However, none of the street vendors had any formal pharmaceutical training and two were children aged 12 and 14. Many of the medicines being sold by street vendors appeared very old and may have been expired. The vendors reported that they could make up to 300 Afghanis (US$6) per day by selling medicines on the street. These grocery stores and young vendors ve ndors are a major threat to public health hea lth efforts in Afghan.
Prices and Import Routes of Pharmaceuticals
Prices of pharmaceuticals in Afghanistan are checked by the MoPH with importers and retailers allowed to make between 10 and 15 percent margin on the sale of medicines, and wholesalers allowed to make an 8–10 percent margin, but many importers and pharmacies stated outright that they did not follow the official pricing guidelines. Most of these traders argued that prices should be unregulated and market-driven, as Afghanistan had a “free market”. There is a serious lack of capacity on the part of MoPH for enforcing regulations on pricing, especially outside Kabul. There is a confusing array of
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pharmaceuticals from different countries, at different prices, of varying strengths and qualities, available on the Afghan market.
Government Regulation and Customs procedures
When medicines arrive at the border entry ports, they are checked by customs staff along with their documentation and then are referred to the main customs offices in provincial capitals. Imports of medicines into Afghanistan are taxed at a rate of four percent and this tax is charged at the main customs offices. Chemical and pharmaceutical raw materials imports are taxed at 2.5 to 5 percent. Value added tax is also charged on pharmaceuticals at two percent.
As there are no laboratories for testing medicines or raw materials for pharmaceutical production at border ports or in provincial customs offices, medicines and raw materials are held in these offices while samples are sent to the MoPH laboratories in Kabul to be tested. This process can be very lengthy, as the laboratory in Kabul itself lacks the staff and equipment to cope with this. As a result pharmaceuticals can be held for up to three months, before being released from Customs. As many medicines require refrigeration, much stock is damaged or destroyed while being held by Customs. Enforcement of proper Customs procedures is generally problematic and the lack of enforcement capacity means that local Customs officials may be granting unfair tax concessions to favored traders. However, those wanting to circumnavigate customs procedures in the pharmaceutical market are probably more likely to avoid declaring their imports at all.
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Problems with the pharmaceutical system
Unfortunately due to war and conflicts a number of quality control labs have been destroyed. Only one quality control lab is working with two machines, which is not enough for the whole country. The government's drug-testing laboratory at Ibn-i-Sina Hospital is another laboratory however much of the equipment there - including microscopes - was acquired during the former Soviet rule and many machines were damaged during the 1999 - 2000 war.
The five-room lab employs 15 pharmacists. The employees report obtaining far less chemicals and other supplies than that needed for proper testing. The government of Finland and the World Health Organization has been assisting the work of the department, which is frequently disrupted by power failures. Currently, all drugs are tested for quality control and assurance by the newly established Afghanistan Independent Standard Organization, located on Jalalabad Road, Kabul.
There are many medicines of very poor quality on the Afghan market. Products of concern that are believed to be present on the market include: counterfeit medicines, expired medicines and medicines that have been banned because of their adverse side effects in the developed world. Medicines banned in Afghanistan such as the analgesic and anti-inflammatory drug, Metamizole, and combinations of Metamizole such as Novalgin and Analgin, are still being imported into Afghanistan and sold by retailers. Expired medicines are available on the private market in Afghanistan. Expiry dates have also sometimes been a problem with donated medicines. The MoPH has publicly burned some stockpiles of expired drugs found on the market on more than one occasion over the
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past year to illustrate its activities in eliminating expired drugs from the market. There is anecdotal evidence that outdated medicines are re packaged as veterinary medicines or for other uses.
Appropriate storage of medicines is also an important issue. Many wholesalers and retailers do not store medicines in suitable conditions, and certain drugs can be damaged by extremes of temperature. Capsules, for example, are damaged by excess heat.
Role of the Ministry of Public Health and improvements in the Pharmaceutical System
The MoPH has an important role in regulating the pharmaceutical market as well as testing of manufactured products, and inspecting manufacturing facilities. However, currently the MoPH faces considerable challenges with the supply and delivery of quality assured drugs. The quality assurance (QA) of drugs imported and sold is not ensured, resulting in a lack of confidence by the population. Moreover, the country cannot rely on solely and external supply; the reinvestigation of some national production by foreign direct investment should be considered.
The Ministry is currently undergoing a restructure. There are many addendums to existing medicine laws currently in the pipeline, similarly aimed at tightening regulation of the pharmaceuticals market. In practice, the MoPH lacks the capability to regulate the wholesale, retail and particularly the import of medicines effectively. The sheer number of imports brought unofficially into the country greatly outweighs the capacity of
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customs and border guards to control them and so does not come to the attention of the MoPH until the smuggled products reach the shelves of wholesale and retail outlets. In the last few years with the continuous struggles of the MoPH drug laws and relevant regulations were drafted and pharmacy directorate was expanded. Based on the new law, national board of drugs was established within the MoPH. An updated essential medicines list4, based on a World Health Organization model, was produced in August 2005 and the national drug donation guidelines were published in April 2003. Afghanistan has a National Medicine Policy, published in January 2004. The Department for Pharmaceuticals has 66 inspectors, including 32 pharmacists, responsible for conducting visits to check the type, quality, date and price of medicines. If these inspectors find substandard or expired medicines on sale, they confiscate and destroy them. Inspectors are active in Kabul every day, and inspections are technically also stationed in the provinces, but it is unclear how effective such inspections are outside Kabul.
In order to further strengthen the pharmaceutical system, the international community is committed to Afghan Health Authorities. The best example is, the recent Programme which is working for the Strengthening of Pharmaceutical Systems (SPS)5 which will run from 2007 to 2012, this five-year Programme will cost $147.5 million, funded by USAID. Strengthening Pharmaceutical Systems is follow-on from the Rational Pharmaceutical Management (RPM) Plus Program. SPS is currently focusing on four key results
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Improved governance in the pharmaceutical sector
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Strengthening of pharmaceutical management systems to support public health services
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Contain the emergence and spread of antimicrobial resistance
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Expand access to and improved use of essential medicines
References
1. Sale of expired, spurious drugs on rise in Afghanista.pak tribune.com Jan 15, 2007http://www.rawa.org/temp/runews/2007/01/15/sale-of-expired-spurious2007http://www.rawa.org/temp/runews/2007/01/15/sale-of-expired-spuriousdrugs-on-rise-in-afghanistan.phtml 2. Meeting with Aisah Noorzai and Zakia Adil in MoPH at 04 Jan 2009 3. Paterson A. Going to Market:Trade and Traders in Six Afghan Sectors. Afghanistan Research and Evaluation UnitSynthesis Paper Series, June 2006 Available at: www.areu.org.af/index.php?option=com_docman&task=doc_view&gid=366 4. National Essential Drug List, Ministry of Public Health, Islamic Republic of Afghanistan Dec 2007. http://www.moph.gov.af/general-directoratepharmaceutical-affairs/medicine-inform-and-developdirectorate/Afghanistan_National_Essential_Drug_List_December_2007.pdf
5.
Afghanistan- Country Report. Strengthening Pharmaceutical System Programme
http://www.msh.org/global-presence/asia/afghanistan.cfm
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