The Latest News From BPOM, The Circular Permit For 32 Circular Drugs Production Of PT REMS Was Revoked Due To Hazardous Chemical Equipment

Head of BPOM RI Penny K Lukito when delivering a statement to reporters regarding the development of the results of supervision and prosecution related to drug sirops contaminated EG/DEG/ANTARA

JAKARTA - The Food and Drug Supervisory Agency (BPOM) revoked the distribution permit for the production of PT Rama Emerald Multi Sukses (REMS) because it showed that the levels of exposure to hazardous chemicals exceeded the safe threshold. The revocation of the distribution permit was announced by BPOM RI through the official pom.go.id website which was confirmed to the BPOM RI Cooperation and Public Relations Bureau in Jakarta, Wednesday, December 7. In his statement, BPOM stated that the witness was part of the results of further investigations of the findings of sirop drugs containing Etylene Glikol (EG)/Diethilen Glikol (DEG) contamination that exceeded the safe threshold. Based on the results of sampling tests on additional products and materials used, as well as further examination of PT REMS' production facilities in Gresik, East Java, EG/DEG contamination was obtained which exceeded the safe threshold for daily intake/Tolerable Daily Intake (TDI) of 0.5 mg/kg of body weight/day. The results of the test of the raw material for the Glikol Propilent used in the therapeutic pharmaceutical drug (IF) showed that the EG levels were 33.46 percent and the DEG was 5.94 percent or exceeded the threshold for the spruce requirement of no more than 0.1 percent and the EG/DEG levels in the sirop drug 1.28 to 443.66 mg/ml which exceeded the safe threshold. "Based on further examination of the production facilities of PT REMS, discrepancies were found in the application of Good Manufacturing Practices of Drug Production (CPOB)," the statement said. For this reason, BPOM stipulates administrative sanctions by revoking the CPOB certificate for non-betaactam oral liquid and followed by the revocation of all distribution permits for 32 sirop drug products produced by PT REMS. These products include Ambroxol HCI, Antasida DON, Broxolic, Calortusin, Calortusin PE, Cetirizine Hydrochloride, Cetirizine Hydrochloride, Cetizine, Cetizine, Cotrimoxazole, Dolorstan, Domperide Maleate, Domperide Maleate, Fenpro, Ibuprofen, Noze, OBH Rama, Paracetamol, Pseudoephedrine HCI, Ramadry Atusin, Ramadry Expectorant, Ramagesic, Remco COugh, R-Zinc, Sucralfate, Tera F, Tera - PE, Zinc Sulfate Monohydrate, and Zinc Sulfate Monohydrate. To see complete information regarding the list of drugs with the following types and batch numbers can be seen on the following link. In addition to administrative sanctions, BPOM also ordered PT REMS to stop the production and distribution of all sirop products, as well as withdraw their products from circulation, which includes pharmaceutical wholesalers, pharmacies, drug stores, and other pharmaceutical service facilities. BPOM also ordered manufacturers to destroy all supplies of sirop drugs, witnessed by BPOM Technical Implementation Unit (UPT) officers and create news of the destruction (BAP). Previously, BPOM had revoked the CPOB Certificate and distribution permits from a number of private pharmaceutical companies in Indonesia because it was proven that using raw materials for chemical compounds exceeded the safe threshold. The companies that received administrative sanctions included PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT Afi Farma, PT Samco Farma and PT Subros Farma.