Table 4. Key Observations About the Regulation of Quality and Availability of TB Medicines^a .

India	Tanzania	Zambia
Regulatory framework
• No comprehensive policy framework for regulation of TB medicines (-) • Manufacture and import of TB medicines not specifically restricted • Drugs and Cosmetics Act and MoHFW guidelines outlined measures to assure quality of procured medicines (+)	• Policy of MoHSW restricted imports to government operators only (++)b	• Import of TB medicines not specifically restricted • PRA and MoH guidelines outlined measures to assure quality of procured medicines (+)	• Production + procurement
• Drugs and Cosmetics Act (universal) and MoHFW guidelines (government sector only) outlined measures to assure norms and standards during stocking and distribution (+)	• MSD and MoHFW guidelines outlined measures to assure norms and standards during stocking and distribution (+)	• PRA and MoH guidelines outlined measures to assure norms and standards during stocking and distribution (+)	• Stocking + distribution
• MoHFW mandated DOTS regimens in all government facilities and in government-affiliated private facilities (+) • National drug schedules required that TB medicines be dispensed only on prescription (+)	• Policy of MoHSW stated that only facilities affiliated to the NTLP were allowed to prescribe and dispense TB medicines, in accordance with DOTS (++)b	• MoH mandated DOTS regimens in all government facilities and in government-affiliated private facilities (+) • PRA norms required that TB medicines be dispensed only on prescription by qualified medical practitioners (+)	• Prescribing + dispensing
Authority and capacity
• Drug controllers faced severe human resource constraints (--)b • Concerns over technical capacity of central and state regulatory authorities (-) • Amendments in laws were in process to increase criminal penalties for defaulters (+) • PQ requirement not universal (at time of study) (-)	• Policy widely supported across constituencies (++)b • Political support for regulatory body (++)b	• Drug controllers faced financial and human resource constraints (-)	• Production + procurement
• Drug controllers faced severe human resource constraints (--)b • Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+)	• Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+)	• Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+)	• Stocking + distribution
• Drug controllers faced severe human resource constraints to controlling dispensing practices, had no authority over prescribing practices (-) • Government recommendations for drug regimens not applicable in private sector (--)b • Professional councils were uninvolved in matters of regulating practices (-)	• Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+) • Professional councils were uninvolved in matters of regulating practices (-)	• Drug controllers faced financial and human resource constraints (-) • Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+) • Professional councils were uninvolved in matters of regulating practices (-)	• Prescribing + dispensing
Implementation
• Some concerns over implementation of quality control. Few instances of penal action (-)	• Faithful implementation of import restrictions (++)b	• No specific observations of barriers or enablers	• Production + procurement
• Drug controllers unable to monitor private distribution (--)b • Inspections and prosecutions infrequent, in private sector (-) • Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+)	• Clear lines of authority and perception of fair monitoring capacity in the government TB programme (+)	• Clear lines of authority and perception of fair monitoring capacity in the government TB programme • Drug controllers ability to monitor private distribution questionable (-)	• Stocking + distribution
• Fair adherence to dispensing, prescribing norms in government facilities (+) • Reports of widespread violation of dispensing, prescribing norms in private facilities (-)b • Inspections and prosecutions of private sector defaulters infrequent (-)	• Fair adherence to dispensing, prescribing norms in government and affiliated facilities (+) • Some reports of abuse of prescription-drug norm in private facilities (-) • Inspections and prosecutions of private sector defaulters infrequent (-)	• Fair adherence to dispensing, prescribing norms in government and affiliated facilities (+) • Several reports of abuse of prescription-drug norm in private facilities (--)b • Inspections and prosecutions of private sector defaulters infrequent (-)	• Prescribing + dispensing
Efficiency, transparency, and accountability
• Perceived inefficiencies in coordinating state and central authorities’ roles (-) • Private representation and political involvement in regulatory affairs widely recognized (--)b	• Perceived improved efficiency resulting from hierarchical control of TB programme, and exclusion of private actors • Perception that efficiency resulting from hierarchical control of TB programme, likely to be attenuated by moves to integrate disease programmes (-)	• Perceived improved efficiency resulting from hierarchical control of TB programme • Risk of donor dependence in drug procurement (-)	• Production + procurement
• Drug controllers prioritized drug quality management over regulating distributors and practitioners (-) • Limited information about distribution networks among informal/small private sector catering to poor (-)	• Perception that efficiency resulting from hierarchical control of TB programme, likely to be attenuated by moves to integrate disease programmes (-)	• Perceived improved efficiency resulting from hierarchical control of TB programme	• Stocking + distribution
• Professional councils rejected role in regulating dispensing and prescribing practices (-) • Drug controllers prioritized drug quality management over regulating distributors and practitioners (-) • Some professional associations opposed government regimens (--)b	• Perceived improved efficiency resulting from hierarchical control of TB programme • Private actors perceived lack of inclusiveness of policy-making by TB programme (-) • Little information about practices of informal/small private healthcare providers (--)b	• Perceived improved efficiency resulting from hierarchical control of TB programme • Little information about practices of informal/small private healthcare providers (--)b	• Prescribing + dispensing

Abbreviations: MoHFW, Ministry of Health and Family Welfare; TB, tuberculosis; NTLP, National Tuberculosis and Leprosy Programme; PQ, Prequalification; PRA, Pharmaceutical Regulatory Agency; MoH, Ministry of Health; DOTS, directly observed therapy short-course; MSD, Medical Stores Department.

^a Constraining and enabling factors are tagged with (-) and (+) signs, respectively.

^b Most frequent and salient observation.