134,274 Bottles Of PT Ciubros Farma's Sirop Milk That Aredefused By Chemical Hazardous Disease Disorders Were Destroyed
SEMARANG - The Food and Drug Supervisory Agency (BPOM) oversees the destruction process of hundreds of thousands of bottles containing sirop drugs containing dangerous chemicals produced by PT Ciubros Farma.Head of BPOM Penny K. Lukito said that today PT Ciubros Farma destroyed the initial phase for Citomol Sirop with 134,274 bottles and Citoprim Suspensi with 57,933 bottles.The products destroyed have been clinically proven to contain Ethilen Glikol (EG)/Diethilen Glikol (DEG) which can cause kidney disorders.The destruction of the drug is a follow-up to the results of sampling and risk-based testing by the BPOM on medicinalORous products produced by PT Ciubros Farma which are proven to contain EG/DEG contamination of 58.45 mg/mL or 246.12 times above the safe threshold.Regarding the sirop drug product that does not meet the requirements (TMS), BPOM ordered the withdrawal of products from circulation throughout Indonesia.In addition, producers are ordered to destroy all bets of sirop medicinal products containing EG/DEG contamination exceeding the threshold." “ On November 7, 2022, a certificate of Good Manufacturing Practices (CPOB) for non-betaactam oral liquid preparation facilities has been revoked and a distribution permit number for all PT Ciubros Farma sirop drug products has been revoked," he said in Jakarta, Antara, Monday, December 12.The drug products PT Ciubros Farma were ordered to be withdrawn and destroyed, including Citomol Sirup, Citoprim Suspensi, Floradryl Sirup, Popalex Sirup Batuk Drug, Citophenicol Suspensi, and Citocetin Suspensi.PT Ciubros Farma is still in the process of withdrawing medicinal products that do not meet the requirements of circulation.Based on data from the PT Ciubros Farma report as of November 29, 2022, the remaining stock of medicinal products and withdrawals from the distribution will be destroyed by a total of 549,064 bottles." “ To ensure that these products are no longer circulating in the community, destruction is carried out against all sirop drug products resulting from withdrawals from circulation and those still in supply, including ineligible solvent raw materials," he said.This initial stage of extermination is carried out at PT Wastec International Semarang, with a method that does not cause a decline in health for humans and does not pollute the environment. The destruction process was witnessed by the BPOM Technical Implementation Unit (UPT) officers as outlined in the Minutes of Eradication."We urge the public not to buy drugs because they are tempted by prices, but buy drugs from legal pharmaceutical service facilities, such as pharmacies and drug stores," he said.If people want to buy drugs online, said Penny, purchases are only made through the Pharmacy Electronic System Operator (PSEF) platform which has obtained permission from the government.On Tuesday (16/12), 223,560 bottles containing Unibebi sirop drugs produced by PT Universal Pharmaceutical Industries (PT UPI) were destroyed in the Cilegon area, Banten, because they contain hazardous chemicals.In detail, there were three types of Unibebi products that were destroyed, namely Unibebi Cough Sirup with plastic bottled bottles @60 ml with Circular Permit Number (NIE) DTL72263037A1, Unibebi Fever bottled bottled bottled bottled up @60 ml with NIE DBL8726301237A1, and Unibebi Fever Drops bottled bottled bottled bottled @15 ml with NIE DBL19233336A1.Until now, BPOM has revoked the CPOB Certificate and distribution permits from a number of private pharmaceutical companies in Indonesia because it is proven that using raw materials for chemical compounds exceeds 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 Ciubros Farma and PT Rama Emerald Multi Sukses (REMS).