"After conducting sample testing and tracing, we had identified six pharmaceutical companies (whose products) exceeded the safe threshold for contamination," Head of BPOM Penny K. Lukito noted during a hearing meeting with Commission IX of the Indonesian House of Representatives (DPR RI) in Jakarta on Wednesday.
The six companies are PT Yarindo Farmatama (PT YF), PT Universal Pharmaceutical Industries (PT UPI), PT Afi Farma (PT AF), PT Ciubros Farma (PT CF), PT Samco Farma (PT SF), and PT Rama Emerald Multi Sukses (PT REMS), Lukito stated.
Lukito said the findings were obtained in 2022 based on the initial case report received by her side on October 5, 2022, related to acute kidney problems in children.
Based on the investigation results, the BPOM has imposed administrative sanctions by revoking the certificates of Good Manufacturing Practices (GMP) and distribution permits that were originally owned by the pharmaceutical companies.
"The pharmaceutical company that commits violations in the field of production has been sanctioned and processed in accordance with applicable legal provisions (pro justicia)," she remarked.
In addition, the BPOM revoked the GMP certificate for non-beta-lactam oral liquid and the Good Drug Distribution Method (CDOB) certificate, revoked the distribution permit for the drug syrup being produced, and conducted an investigation into the pharmaceutical company suspected of having committed a crime.
Lukito stated that the BPOM ordered the pharmaceutical industry and large pharmaceutical manufacturers to stop producing syrup drugs, return the approval letters for distribution permits for all syrup drugs, and withdraw and ensure that all drug syrups have been taken off from circulation.
Moreover, the BPOM ordered the destruction of all drug syrup supplies under the observation of the BPOM Technical Implementation Unit (UPT) officer by making an official report on the destruction.
Lukito reported that the results of independent testing by manufacturers found that 508 syrup drug products from 49 pharmaceutical industries met the requirements and were safe to use as long as they were according to the rules of use.
In addition, as many as 177 syrup drug products do not use EG/DEG or Propylene Glycol (PG) solvents, so they are safe for consumers to use, she stated.
Moreover, as many as 8,493 drug sales links containing EG/DEG on the online market during the period from October 21, 2022, to February 12, 2023, have been taken down, she remarked.
Related news: Government continues investigating cause of child kidney failure cases
Related news: Ministry cautions against buying syrup medicine without prescription
Translator: Andi Firdaus, Resinta S
Editor: Rahmad Nasution
Copyright © ANTARA 2023
