Bangladesh pharmaceutical profile 2017

OVERALL SPENDING ON HEALTH Total per capita spending on health care (current US$) 4 Total per capita spending medicines (current US$) 5 Share of government vs. out-of-pocket spending on health 4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost 5 Share of public and out-of-pocket spending on medicines Pe rc en ta ge ( % ) 44.6% 0 20 40 60 80 100 2005 2008 2011 2014 COUNTRY AT A GLANCE 160996 Population (in 000s)1 71.8 Life expectancy at birth (in years)2 1212 GDP (per capita in current US$)3 Bangladesh pharmaceutical profile 2017 MEDICAL AND PHARMACY WORKFORCE 47.2 Medical practitioners/10 000 population6 48.1 Pharmacists & pharmacy technicians/10 000 population6 7.6 Registered pharmacists/10 000 population6 $13 $31 0 5 10 15 20 25 30 35 2005 2008 2011 2014 C ur re nt U S $ 67% 33% 0 20 40 60 80 100 2005 2008 2011 2014 Pe rc en ta ge ( % ) No data available Bangladesh pharmaceutical profile 2017 KEY MEDICINES POLICIES AND GUIDANCE Key Pharmaceutical Legislation13 National Medicine Policy14 National Essential Medicines List14 National Standard Treatment Guidelines15 Drug Control Ordinance Amendment Act 2006 National Drug Policy 2016 Essential Drug List - 2016 Individual guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of Local pharmaceutical manufacturers 16 Least Developed country status since17 Member of World Trade Organization since18 TRIPS flexibilities used19 814 pharmaceutical manufacturers including 266 allopathic, 202 ayurvedic, 272 unani, 32 herbal & 42 homeopathic manufacturers 1975 1995 Not applicable until graduation from least developed country status ACCESS TO MEDICINES HIV/AIDS, Malaria and Tuberculosis treatment coverage 7,8,9 Diphtheria-tetanus-pertussis (DTP3) and Hepatitis B3 immunization coverage 10 Hypertension treatment coverage11 Access to palliative care: Opioid consumption in Morphine Equivalence (ME) minus Methadone12 Pe rc en ta ge ( % ) 15% 100% 57% 0 20 40 60 80 100 120 140 2005 2008 2011 2014 Pe rc en ta ge ( % ) 0 20 40 60 80 100 94% 94% 2005 2010 2015 Data for age group 18-69 years Data on Diabetes Mellitus treatment coverage not available Morphine Equivalence minus methadone represents country capacity to deliver palliative care, because it excludes treatment for drug dependency 0 20 17.9% 40 60 80 100 People with raised Blood Pressure (SBP ≥140 and/or DBP ≥90 mmHg and/or taking medication Data for > 25 Pe rc en ta g e (% ) 0.1966 0 0.05 0.1 0.15 0.2 0.25 1999 2004 2009 m ili g ra m p er p er so n Bangladesh pharmaceutical profile 2017 Pharmaceutical system flowchart Market Authorization/ Licensing/Quality Assurance Medicine Patient Medicine Selection Medicine Procurement Pricing and Reimbursement Distribution National Regulatory Authority14: Directorate General of Drug Administration (DGDA) www.dgda.gov.bd Regulated products: Medicines: YES Vaccines YES Medical devices: YES Traditional medicines16: YES Medicine Quality Control Laboratory20: National Control Laboratory, Dhaka and Central Drug Testing Laboratory, Chittagong ISO 17025 certified15,A: NO WHO prequalified15,B: NO Number of registered medicines16: Total 39844: allopathic 27624, ayurvedic 3877, unani 5624, herbal 406, homeopathic & biochemical 2313 Agency responsible for selection14: Directorate General of Drug Administration Number of products on essential medicines list: By active ingredient14: 285 allopathic drugs By dosage form16: Not available Traditional medicines products included in essential medicines list: YES Medicines availability is indicated by health facility levelC: NO National formulary: Bangladesh National Formulary (BDNF) 2015 Public sector Agency responsible for public procurement21: Central Medical Stores Depot (CMSD) Procurement done at Central: State: Facility22: (local procurement for district facilities and hospitals) Commonly used procurement methods23: National/ International bidding Public sector Agency responsible for distribution22: Essential Drug Company Limited and CMSD Public sector facilities27: Referral hospitals: 46 District level hospitals: 64 Specialized hospitals: 124 Public sector Price control13,24,D: YES Agency responsible for price control15: DGDA Patient prices for essential medicines in public sector:25 Free medicines: YES Private sector Number of wholesalers23: 1005 Private sector Number of retail outlets28: 123800 Licensed retail pharmacies per 10 000 population29: 7.7 Number of traditional medicines outlets30: 353 Ayurvedic retail outlets, 616 unani outlets, 10 herbal outlets & 2056 homeopathic outlets Private sector Agency responsible for price control25: Price Fixation Committee for 117 primary health care medicines. Pricing mechanism26: Manufacturer: (Maximum Retail Price is based upon cost of raw material and packaging plus a mark up) Wholesale: Retailer: DGDA controls retail margin (partially) Mark-ups regulated: YES Fixed or regressive: Fixed Bangladesh pharmaceutical profile 2017 References 1. United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects, the 2015 revision. New York, 2015. https://esa.un.org/ unpd/wpp/ -accessed 12 May 2017. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. http://www.who.int/gho/mortality_burden_disease/life_tables/en/ - accessed 12 May 2017. 3. The World Bank. World development indicators 2016. Washington DC. http://databank.worldbank.org/data/reports.aspx?source=world-development-indicators - accessed 12 May 2017. 4. World Health Organization. Global Health Expenditure Database (GHED): total health expenditure. Geneva. http://apps.who.int/nha/database/Select/Indicators/ en - accessed 12 May 2017. 5. World Health Organization. National Health Accounts, Bangladesh. World Health Organization, Geneva. Internal communication, April 2017. 6. Data taken from South East Asia Region health workforce survey April 2016. 7. United Nations Programme on HIV/AIDS. Estimates of coverage of people receiving ART. Bangladesh. http://aidsinfo.unaids.org- accessed 19 May 2017. 8. World Health Organization. World malaria reports. Geneva. http://www.who.int/malaria/publications/world_malaria_report/en/ - accessed on 19 May 2017. 9. World Health Organization. Global Health Observatory (GHO) data. Geneva. http://apps.who.int/gho/data/view.main.57060ALL?lang=en -accessed 19 May 2017. 10. World Health Organization. WHO/UNICEF estimates of national immunization coverage. Geneva. http://apps.who.int/immunization_monitoring/globalsummary -accessed 19 May 2017. 11. World Health Organization. Non-Communicable Diseases Risk Factors survey Bangladesh 2010. New Delhi, 2011. http://www.who.int/chp/steps/2010_STEPS_ Report_Bangladesh.pdf?ua=1 -accessed 11 June 2017. 12. Pain & Policy Studies Group. Country Profiles: Opioid consumption in Morphine Equivalence (ME) minus Methadone. University of Wisconsin, USA. 2015. http:// www.painpolicy.wisc.edu/countryprofiles -accessed 19 May 2017. 13. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Drug Control Ordinance Amendment Act 2006. DGDA, Ministry of Health & Family Welfare, Bangladesh. http://www.dgda.gov.bd/index.php/laws-and-policies/88-drug-control-ordinance-2006 accessed June 2017. 14. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. National Drug Policy 2016. DGDA. Ministry of Health & Family Welfare, Bangladesh. http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/guidance-documents/205-national-drug-policy-2017-with-essential-drug-list-and-otc-list/ file accessed June 2017. 15. As reported by Ministry of Health & Family Welfare, Bangladesh, May 2017. 16. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/2013-03-31-05-16- 29/drug-manufacturers/allopathic, http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/drug-manufacturers/ayurvedic, http://www.dgda.gov.bd/index. php/2013-03-31-05-16-29/drug-manufacturers/unani, http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/drug-manufacturers/herbal,http://www.dgda. gov.bd/index.php/2013-03-31-05-16-29/drug-manufacturers/homeopathic-and-biochemic-accessed 25 July 2017. 17. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2016. http://www.un.org/en/development/desa/ policy/cdp/ldc/ldc_list.pdf - accessed 12 May 2017. 18. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva, 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e. htm -accessed 21 June 2017. 19. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/ country_profile/ –accessed 21 June 2017. 20. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/2013-11-17-09-29-57/ quality-manual/40-quality-manual-1 - accessed 25 July 2017. 21. Central Medical Stores Depot, Ministry of Health & Family Welfare. Bangladesh. http://www.hsmdghs-bd.org/CMSD%20Procurement.htm - accessed 12 June 2017. 22. Ministry of Health & Family Welfare, Bangladesh. http://www.mohfw.gov.bd/ -accessed 12 June 2017. 23. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/pharmacies/whole-sale- pharmacy-view - accessed 23 June 2017. 24. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. Guidance document. DGDA, Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/guidance-documents/11-price-fixation-procedure - accessed 25 July 2017. 25. World Health Organization, Regional Office for South East Asia. Medicines in health care delivery- Bangladesh 2014. New Delhi, 2015. http://www.searo.who.int/ entity/medicines/bangladesh_situational_analysis_2015.pdf?ua=1 – accessed 12 June 2017. 26. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. Drug Pricing Committee. DGDA. Bangladesh. http://www.dgda. gov.bd/index.php/downloads/committees/drug-pricing-committee/48-drug-pricing-committee - Accessed 25 July 2017. 27. Directorate General of Health Services. Secondary and Tertiary Hospitals. Directorate General of Health Services, Bangladesh. http://www.hsmdghs-bd.org/Govt_ Hospital.htm– accessed 12 June 2017. 28. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/pharmacies/allopathic- retail-pharmacy-view - accessed June 2017. 29. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Monthly work update of DGDA. Ministry of Health & Family Welfare, Bangladesh. April 2017. http://www.dgda.gov.bd/index.php/registration-dashboard - accessed June 2017. 30. Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare. Bangladesh. http://www.dgda.gov.bd/index.php/pharmacies/ayurvedic- retail-pharmacy-view, http://www.dgda.gov.bd/index.php/pharmacies/unani-retail-pharmacy-view, http://www.dgda.gov.bd/index.php/pharmacies/herbal-retail- pharmacy-view, http://www.dgda.gov.bd/index.php/pharmacies/homeopathic-and-biochemic-retail-pharmacy-view - accessed June 2017. Notes: A As per action plan National Control Laboratory is optimistic to get ISO 17025 certificate within 2018. B. As per action plan National Control Laboratory is optimistic to get WHO Prequalification within 2019. C. Health facility level & drug availability level indicated in Essential health Service Package (ESP) of Ministry of Health & Family Welfare. D. In the Section 11 Fixation of price of drugs in the Drug (Control) ordinance - 1982 it is noted that “The Government may, by notification in the official Gazette, fix the maximum price at which any medicine may be sold.”