Pharmaceutical System Strengthening : Bangladesh Perspective

1. Pharmaceutical System Strengthening : Bangladesh Perspective Aktari Mamtaz Joint Secretary Ministry of Health and Family welfare (MOHFW), Bangladesh

2. Bangladesh: Country Profile • Country Area : 1.47.570 sq. km. • Total Population : 151.41 Million (BBS 2010) • Population Density (per sq. km.) : 993 persons (BBS 2009) • Life Expectancy at Birth- Male : 65.7 years (BBS 2009) Female : 68.3 years (BBS 2009) • Maternal Mortality Rate (MMR) ( per 1000 live births ) : 1.94 (BMMS 2010) • Infant Mortality Rate( per 1000 live births): 52 (BDHS 2007) (<1 Yr) • Neonatal Mortality Rate (<1 Month) : 37 percent (BDHS 2007) • Child Mortality Rate (<5 ) : 65 per 1000 live births • (BDHS 2007) • Per Capita Income :US$ 818 2

3. Achievements made so far • Bangladesh has made considerable progress in high rates of economic growth and reducing poverty rates by 8 per cent between 2005 and 2010. • In 2010, Bangladesh received the Millennium Development Goal (MDG) award for remarkable achievement in reducing child mortality (MDG 4). • Bangladesh is also currently on track to meet MDG 5 (Maternal Health) • Bangladesh received Digital Health for Digital Development award in 66th UN General Assembly for contributing Maternal and Children Health through ICT.

4. Achievements made so far(cont.) • Local pharmaceuticals contribute 90% of medicine production in Bangladesh. • Leading 20 local companies have achieved recognition from International top regulatory authorities like,- UK, EU Australia, GCC(Gulf Cooperation Council), and many other regulatory authorities. • Bangladesh pharmaceutical companies are now exporting medicines in 84 countries, among them UK, USA, Turkey, Thailand, Singapore etc. • DGFP Supply Chain Information Portal (SCIP) has received two awards in e-Health and e-Governance category in the National Digital Innovation Award- 2011

5. Types of Pharmaceuticals in Bangladesh

6. Government’s Tools for Managing Pharmaceutical Sector & Improve Use of Medicines • A dedicated department- Directorate Generals of Drug Administration • National Drug Policy Since 1982 , and updated in 2005 • Drugs (Control) Ordinance,1982, reviewed in 2005 • Drug rules and regulation, 1945 and 1946 • Drug Testing Laboratory at Dhaka and at Chittagong

7. Government’s Tools for Managing Pharmaceutical Sector & Improve Use of Medicines(cont.) • Essential drug lists for health professional (updated in 2008) to ensure rational use of medicines. • Bangladesh National Formulary (last updated in 2006) for appropriate use of medicines. • STGs (Standard Treatment Guidelines) for certain diseases – TB, leprosy, Malaria etc.

8. Management steps of pharmaceutical products in Bangladesh • Registration: Any medicine either manufactured or imported should be registered to Directorate General of Drug Administration (DGDA) • Selection: The Drug Control Committee of DGDA will select a medicine either for manufacture or import. Quality , safety, effficacy and usefulness is the criteria of selection. • Production: After registration and Selection a manufacturer could go for production. An importer could import.

9. Management steps of pharmaceutical products in Bangladesh(cont.) • Quality Assurance: According to NDP DGDA will ensure good quality medicines available at affordable price and WHO Good Manufacturing Practice (GMP) guidelines should followed by manufacturer’s. • Procurement: According to requirement CMSD,DGHS and LMU ,DGFP procure medicines and contraceptives for GOB service delivery centre's. • Distribution: Govt. Chanel and Private Chanel. Web-based Logistics Management Information System (LMIS); Inventory Management Software for DGFP at Sub district and Warehouse level ensures good management of contraceptives distribution.

11. Stakeholders in Pharmaceutical Management in Bangladesh • Pharmaceutical companies, Public / Private • Health Service delivery facilities, Public/Private/ NGO • Health Service Providers, Public/Private/NGO • Importers • Manufacturers • Distributors • Medicine Sellers • Users/ patients

12. Medicine Supply Chain (Private): Importers Manufacturers • local production of drug: 83,850 million in 2010 • Imported drug :10,710 million in 2010 Pharmacies (Retail drug shop) Others

13. Source of medicines for patients seeking care *92% of patients get their medicines from pharmacies or retail outlets. *Source: HIES 2005

14. Challenges/problems • Lack of effective monitoring system • Inadequate management capacity for effective implementation of existing legislation and policies and guidelines • Quality assurance of the pharmaceuticals coupled due to lack of independent lab for testing products.

15. Challenges/problems • Human Resources – inadequate trained staff. • Lack of affordability – GOB’s resource constraint to pay for medicine procurement and also for Individuals to pay for medicines. • Shortage of manpower in National Regulatory Authority.

16. Challenges/problems(cont.) • Gaps and weaknesses in existing rules and regulations • Inappropriate use of medicines – anybody can buy any medicine from medicine shops without prescription • Lack of awareness & knowledge amongst users and availability of information

17. Way Forward… Strengthen norms, standards and policy options; promote quality of medical products, vaccines and technologies. Efficient procurement systems to combat counterfeit and sub- standard medical products, vaccines and technologies. Promote good governance and transparency in procurement and medicines pricing.

18. Way Forward…(cont.) • Strengthening capacity of drug administration authority. • Ensure equitable access, rational use and adherence to quality medicine • Monitor quality and safety of products/vaccines/technologies. • Establish Active pharmaceutical Ingredients (API) park, which could enable local pharmaceutical companies to produce raw materials. • .

19. Way Forward…(cont.) • Comprehensive capacity building plan for all relevant personnel involve in – supply chain management • Effective expansion of Introduced telemedicine and e-health services • Automated patient registration and medicines management system. • Establish Procurement web portal under the Procurement and Logistics Management Cell (PLMC) of Ministry of Health and Family Welfare (MOHFW), which could help to track on line medicine procurement and supply.

20. Thank you