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Coordination Meeting for Production Permits and Transfer of Radioisotopes and Radiopharmaceuticals in Hospitals
Kembali 13 Maret 2024 | Berita BAPETEN

BAPETEN's Directorate of Licensing for Radiation Facilities and Radioactive Substances (DPFRZR) held a hybrid coordination meeting on March 13, 2024, to discuss several matters related to business permits that must be carried out by hospitals that have cyclotrons and can transfer radioisotopes and radiopharmaceuticals to several hospitals that have diagnostic medicine services in vivo using Positron Emission Tomography-Computed Tomography (PET-CT).

The coordination meeting was attended by the Director of Pharmaceutical Resilience and Medical Devices at the Ministry of Health, Roy Himawan; Head of the DKI Jakarta Provincial Land and Spatial Planning Department, Heru Hermawanto; Director of Investment Deregulation at the Ministry of Investment/BKPM, Dendy Apriandi; and representatives from Dharmais Cancer Hospital. Meanwhile, from BAPETEN, the Deputy for Licensing and Inspection, the Director of Supervision of Radiation Facilities and Radioactive Substances (DP2FRZR) and staff, the Director of DPFRZR and staff, as well as the Coordinator of the BPIK Data and Information Function Group and staff, were present.

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The event was opened by the Director of DPFRZR, Ishak, who said that the background to the meeting was that there is a hospital that has cyclotron facilities that can produce radioisotopes and radiopharmaceuticals for nuclear medicine services, which so far has been dedicated to its own needs but is in line with the increase and development of nuclear medicine services, especially in Jakarta. Hospitals with excess production will distribute it to other hospitals that have nuclear medicine facilities.

"It has become a problem and challenge where hospitals experience problems in applying for transfer permits to distribute radioisotopes and radiopharmaceuticals because there are special policies implemented in the OSS system regarding the Suitability of Space Utilization Activities (KKPR), which is the basic requirement for business licensing in accordance with the provisions of Gubernatorial Regulation No. 31 of 2022 concerning the Detailed Spatial Planning Plan (RDTR) for the DKI Jakarta Provincial Planning Area," explained Ishak.

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This was strengthened by a statement from the Director of Pharmaceutical Resilience and Medical Devices at the Ministry of Health, Roy Himawan, that "there is a need for discussion and solutions to the problems faced by the Ministry of Health. Currently, the Ministry of Health is expanding cancer services through nuclear medicine, which is really needed by the community with cancer diagnoses using radiopharmaceuticals where there are cases. Patients need 6 months of treatment to recover. Of course, this is sad for Indonesia, which has a large population spread throughout the region. "Compared with other countries such as Singapore, India, and Malaysia, they have cyclotrons that can provide cancer therapy to more than 10 hospitals," said Roy Himawan.

So, added Roy Himawan, the Ministry of Health has planned the availability of radiopharmaceuticals in hospitals and industries. "We view a cyclotron as important because it can supply radiopharmaceutical needs and will develop not only on Java but on large islands such as Medan, Balikpapan, Manado, and Makassar, as well as not only in hospitals but also industrially to supply radiopharmaceutical needs in hospitals. ," he continued.

"It is important that distribution from hospital to hospital does not violate existing regulations so that it can make a significant contribution to society and be quickly handled in quality cancer therapy services," he continued.

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Meanwhile, the Head of the DKI Jakarta Provincial Human Settlements, Spatial Planning, and Land Service, Heru Hermawanto, conveyed simple principles in spatial planning in the context of urban space with various types of businesses where processes that are not directly related are not permitted. "KBLI should not be attached to spatial planning, which is what the hospital sees as its industry will be allowed as long as it complies with appropriate building technical standards and is included in the OSS system," said Heru.

Director of Investment Deregulation, Dendy Apriadi, said, "We are looking for a solution to make location permits more flexible; KKPR according to KBLI is like a lock; KKPR will only apply to those who have the same entity according to risk-based KBLI, which previously was not included in KBLI."

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BAPETEN's Deputy for Licensing and Inspection, Zainal Arifin, conveyed his direction and response regarding this matter. "There is a problem with the distribution of radiopharmaceuticals from cyclotron facilities to other hospitals, we are not stopping cancer patient service activities. With this meeting, we hope to find the best solution and not violate regulations. so that Indonesia can progress and sick people can quickly get healthy," said Zainal.

The coordination meeting was closed by Ishak, who conveyed important conclusions that must be followed up on immediately. "BKPM will facilitate the system related to solving the problem of distributing radiopharmaceuticals from hospitals to other hospitals on a case-by-case basis based on regulations from the Ministry of Health for hospitals that can produce and distribute radioisotopes and radiopharmaceuticals," he concluded. [DPFRZR/Dwiangesti/BHKK/Bams/GP]


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