Strengths and Weaknesses of TB Drug Management Bangladesh, India, Kenya, The Philippines, and Uzbekistan

Key Weaknesses of TB Drug Management in:  Bangladesh  India  Kenya  Philippines  Uzbekistan

Registration Policy Issues  Registration of donated products could be a problem, and reregistration may be needed.  Standard registration can take a long time (6–12 months), and fast-track registration may not be possible.

Procurement Policy Issues  Prequalification is not in place in the existing procurement system—ICB can lead to delays  Exemptions to policy are difficult to secure  GDF support may not conform to national procurement procedures  Guidelines for drug procurement may exist, but policies and enforcement may be lacking  Lack of dialogue between government, funding, and supply agencies

Quality Policy Issues  Quality procedures exist in all countries but enforcement is weak  Quality control exists but quality assurance does not  No systematic quality assurance procedures for pre- and postregistration of drugs

 Need for standardization in treatment regimens to impact all aspects of drug policy and management support  Issues related to TB are very different from other infectious diseases and require a national policy to address their unique aspects (resistance, long-term therapy, FDCs) Other Policy Issues

Management Support  Any change in the system will require HR investment (training, etc.)  Capturing key information (needs assessments, resource allocation, etc.) related to all TB operations is necessary to make decisions  Methodology for gathering information exists, though implementation is weak