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Universidad de Antioquia fabricará 1,3 millones de dosis de Cloroquina para reforzar la lucha contra la malaria
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La Universidad de Antioquia obtuvo registro sanitario del Invima y lanzará la producción industrial de Cloroquina para abastecer 1,3 millones de dosis anuales contra la malaria en Colombia.
Registro sanitario y convenio estratégico
El Invima concedió el registro sanitario 2025M-0022020 a la Planta de Producción de Medicamentos Esenciales de la UdeA adscrita a la Facultad de Ciencias Farmacéuticas y Alimentarias (Cifal) , autorizando la fabricación industrial de Cloroquina, medicamento esencial en el manejo de la malaria . Este aval marca la primera vez en Colombia que una planta pública universitaria obtiene el permiso para producir un fármaco de interés prioritario en salud pública. La autorización se enmarca en un acuerdo suscrito entre la Universidad de Antioquia, el Ministerio de Ciencia, Tecnología e Innovación y el Ministerio de Salud, cuyo objetivo es desarrollar cuatro medicamentos estratégicos dirigidos a enfermedades desatendidas y favorecer la soberanía farmacéutica nacional.
Impacto en la lucha contra la malaria
La malaria afecta con especial gravedad a poblaciones dispersas de la Amazonía, la Orinoquía, la costa Pacífica y los valles de los ríos Cauca y Sinú, donde comunidades indígenas y afrodescendientes registran los picos más altos de incidencia . De acuerdo con el Ministerio de Salud, Colombia reporta entre 50.000 y 100.000 casos anuales de malaria, causada por parásitos del género Plasmodium transmitidos por el zancudo Anopheles.
Si bien los biológicos de primera línea como la quinina y la artemisinina cubren la mayor parte del tratamiento, la Cloroquina continúa siendo la opción de elección en regiones de baja resistencia, especialmente contra P. vivax. La disponibilidad local e industrial de 1,3 millones de tabletas al año busca garantizar continuidad en la cadena de suministro y reducir brechas de acceso en áreas remotas.
Tecnología, calidad y capacidad de producción
La Planta de Producción de Medicamentos Esenciales de la UdeA cuenta con más de 30 años de experiencia en formulación farmacéutica y opera bajo los lineamientos de Buenas Prácticas de Manufactura (GMP) de la OMS, que exigen procesos claramente definidos, validados y documentados para asegurar la calidad constante de los lotes producidos.
Sus instalaciones incluyen líneas de granulado húmedo, secado, compresión de tabletas y recubrimiento, complementadas con laboratorios de control de calidad equipados para ensayos de disolución, uniformidad de contenido y estabilidad acelerada. Tras la emisión de la orden de compra, se proyecta que en los próximos dos meses se entregue al Ministerio de Salud el primer lote de 240.000 tabletas de 150 mg, parte de las 1.300.000 unidades que cubrirán la demanda nacional durante el año.
Soberanía farmacéutica y modelo universitario
Según el decano Wber Ríos Ortiz, la alianza con el Gobierno Nacional promueve la reducción de la dependencia de importaciones y fortalece las capacidades nacionales en investigación y producción: “Confiar en los 220 años de trayectoria de la UdeA y en 11 grupos de investigación especializados en formulación farmacéutica ha sido clave para este logro”, afirmó Ríos Ortiz.
Así mismo, el modelo universitario facilita catalizar el conocimiento académico hacia la producción masiva, incorporando prácticas de transferencia tecnológica, formación de talento humano y articulación con redes regulatorias, lo cual contribuye a consolidar un ecosistema científico-industrial robusto en Colombia.
Perspectivas de ampliación de la cartera de medicamentos
Además de la Cloroquina, la UdeA avanza satisfactoriamente en los registros sanitarios de Niclosamida, Benznidazol y Praziquantel, dirigidos al tratamiento de enfermedades como esquistosomiasis y Chagas . Se espera que estos tres fármacos obtengan su aprobación antes de finalizar 2025, completando así cuatro medicamentos producidos en la planta este año. Esta diversificación estratégica no solo impacta en la salud pública, sino que sienta las bases para futuros desarrollos en terapias contra VIH y otras enfermedades huérfanas, ampliando el repertorio de insumos farmacéuticos de origen nacional.
Desafíos y recomendaciones para el abastecimiento nacional
Aunque la iniciativa representa un avance significativo, persisten retos logísticos y de gestión:
- Distribución en zonas rural-aisladas. Es imprescindible fortalecer rutas de frío y cadenas de suministro terciarias para asegurar la llegada oportuna de dosis en territorios selváticos y de difícil acceso.
- Monitoreo de resistencia. Se recomienda implementar un programa de vigilancia genotípica y fenotípica de Plasmodium para detectar posibles aumentos en la resistencia a la Cloroquina y ajustar protocolos terapéuticos.
- Sostenibilidad financiera. Garantizar la asignación presupuestal a largo plazo y estudiar esquemas de cofinanciación público-privados para mantener la operatividad de la planta ante fluctuaciones de demanda.
- Capacitación continua. Fortalecer la formación de recursos humanos en GMP, aseguramiento de calidad y regulación farmacéutica, para sostener y escalar la producción local.
Mirada al futuro: retos y oportunidades
La puesta en marcha de la producción industrial de Cloroquina en la Universidad de Antioquia representa un hito para la salud pública colombiana, al tiempo que fortalece la soberanía farmacéutica y democratiza el acceso a tratamientos esenciales. Con la expectativa de sumar tres nuevos registros en el corto plazo y consolidar mecanismos de seguimiento de resistencia, la UdeA se posiciona como un actor estratégico en el desarrollo farmacéutico nacional, marcando un precedente para futuras iniciativas de producción universitaria de medicamentos.
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