Table 2.

Pattern of themes.

Codes	Sub-Theme	Theme
I do not know Never heard Do not affect people at the top Orphan diseases lack attention from government and policymakers There is no orphan disease Do not remember criteria for orphan disease A drug with high demand but not available Criteria involves population and availability of alternative medicines	Inadequate knowledge on orphan diseases, medicines, and Tanzania Orphan Drug Regulation of 2018	Barriers to production and importation of HU
Lack of facilities Need for specialized equipment and expertise Poor supporting infrastructures Manufacturer’s batch size requirement No ongoing importation No plan for importation	Lack of infrastructure and resources to import or manufacture hydroxyurea
I do not have exact statistics on number of SCD patients Where to obtain data? They lack data I do not know Stakeholders lack knowledge on hydroxyurea (HU) Not aware of HU effect and side effect I do not know much about HU Never dispensed HU I do not know how HU is used in SCD	Inadequate awareness of sickle cell disease and hydroxyurea
Market is not guaranteed Limited market No demand of HU Fear of getting loss High costs of importation	Limited market and investment viability
Sickle-shaped cells Production of abnormal red blood cells Is a genetic abnormality Symptoms include severe pain SCD is a rare disease Hydroxychloroquine is used to treat SCD Pen V used in management in management of SCD HU available in solid dosage form HU is hygroscopic HU is not available	Basic knowledge of sickle cell disease and hydroxyurea	Opportunities for importation and manufacturing of hydroxyurea
Ready to serve the public need Ready to import HU when demand is available Focus on public interests Readiness for contract manufacturing	Sense of corporate social responsibility and readiness to import or manufacture hydroxyurea
Regulatory authority provides training Regulatory authority conducts scheduled inspection or when needed Conduct annually inspection Expedited review for application of orphan medicines Exemption for orphan drug registration/retention Regulatory authority conducts scheduled inspection or when needed	Awareness of activities performed by the medicines regulatory authority
Exemption on importation duty of raw materials Existence of special market for HU Existence of chances to order drug under special permit	Favorable government policy