One of the main programs of the Ministry of Health in Health System Transformation is to increase the resilience of pharmaceuticals and medical devices. One of the agendas for increasing the resilience of the pharmaceutical sector is to increase the fulfillment of the need for chemical raw materials/Active Pharmaceutical Ingredients (API), biological products, vaccines, and natural (phytopharmaca) domestic production and increase their utilization in the country and exports.
To realize this, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Pharmaceutical and Medical Device Resilience held a meeting "Evaluation of Progress in the Development of the 10 Largest Chemical Drug Raw Materials By Value Developed and Produced Domestically in the Third Quarter of 2022". The event, which was held on September 6, 2022 in Jakarta, was attended by industry representatives who have and will develop domestic chemical raw materials, the Center for Health Security System Policy and Health Resources, and related work units within the Directorate General of Pharmaceuticals and Medical Devices.
In his report, Director of Pharmaceutical and Medical Device Resilience Roy Himawan said that the Directorate of Pharmaceutical and Medical Device Resilience has 9 KPIs, one of which is the largest number of chemical drug raw materials by value developed and produced domestically.
"Of the 10 largest consumer drug molecules, currently only 5 drug molecules whose raw materials have been produced domestically, namely Paracetamol, Clopidogrel, Amlodipine, Omeprazole, and Atorvastatin. Change source facilitation will be carried out for drug raw materials that can be produced domestically. In 2022 the main targets are Atorvastatin and Clopidogrel while for 2023 it is Candesartan and Bisoprolol," said Roy Himawan.
Meanwhile, Director General of Pharmaceuticals Rizka Andalucia in her remarks added that the Directorate General of Pharmaceuticals actively and consistently encourages, oversees, and evaluates the domestic BBO development process, from upstream to downstream. "Upstream, the Directorate General of Pharmaceuticals always coordinates with the BBO industry to assist the BBO development process until it obtains a GMP certificate and can be produced. The Directorate General of Pharmaceuticals also coordinates with academics and industry as well as related cross-sectors to develop domestic BBO so that it can be produced from its initial or intermediate sources," said the Director General of Pharmaceuticals.
Meanwhile, downstream, the Directorate General of Pharmaceuticals encourages the formulated pharmaceutical industry to change the source of imported raw materials with domestically produced raw materials through the Facilitation Program for Change Source of Domestic Production Drug Raw Materials. "This program is a form of the government's commitment to continue to prioritize the use of domestic products (PDN) and become a milestone in realizing the resilience of the pharmaceutical sector in the country, while still paying attention to the fulfillment of product requirements that are safe, quality, and efficacious," said the Director General of Pharmaceuticals.
The sectoral e-catalog is expected to support the improvement of pharmaceutical sector resilience. Domestic products that use domestically produced raw materials (products with a TKDN value of >50%) are prioritized to be selected by users, in this case health facilities.
With this market guarantee, especially in the procurement of government goods and services, it is expected to spur the economic growth of the domestic BBO industry as well as for the pharmaceutical industry to transform into a research-based pharmaceutical industry to support the transformation of the national health system.
In the future, if domestic raw materials can be produced and the capacity is sufficient to meet national needs, then the Minister of Health's direction is that BBO imports can be stopped to support the domestic BBO industry in total.