Semarang, Central Java (ANTARA) – The Food and Drug Supervisory Agency (BPOM) directly monitored the destruction of PT Ciubros Farma’s medicinal syrups that failed to meet regulatory requirements and were found to be contaminated with ethylene glycol (EG) or diethylene glycol (DEG).
The medicines were destroyed at PT Wastec International, Candi Industrial Area, Semarang, Central Java, on Monday, using the incineration method, which does not adversely impact human health or pollute the environment.
BPOM head Penny K. Lukito informed that the destruction was a follow-up to the risk-based sampling and testing of drug syrups produced by PT Ciubros Farma by the agency, which were found to contain 58.45 mg/ml of EG/DEG contaminants, or 246.12 times above the safe threshold.
If medicinal syrups do not meet regulatory requirements, the BPOM orders their withdrawal from distribution networks across Indonesia. If any products contain EG/DEG contaminants in excess of the safe threshold, it orders their destruction.
“On November 7, 2022, the certificate of good manufacturing practice (GMP) for the non-betalactam oral liquid preparation facility was revoked and the distribution license number of all PT Ciubros Farma medicinal syrup products was also revoked,” Lukito informed.
The PT Ciubros Farma drug products that have been recalled and destroyed include Citomol syrup, Citoprim suspension, Floradryl syrup, Popalex cough syrup, Citophenicol suspension, and Citocetin suspension.
“Today, PT Ciubros Farma carried out the initial stage of destruction of 134,274 bottles of Citomol syrup and 57,933 bottles of Citoprim suspension,” the BPOM head said.
PT Ciubros Farma is still in the process of withdrawing its medicinal products that do not meet the requirements, she said.
Based on PT Ciubros Farma’s report as of November 29, 2022, the remaining stocks of medicinal products and those that will be withdrawn from circulation and destroyed amount to 549,064 bottles.
“To ensure that these products are no longer circulating among the public, we will destroy all medicinal syrup products that have been withdrawn from circulation or are still in stock, including solvent raw materials that do not meet the requirements,” Lukito said.
She reminded people to not buy drugs based on the price, but after checking the credentials of pharmaceutical service facilities such as pharmacies and drug stores.
“If the public wants to buy drugs online, they can only purchase them through the electronic pharmaceutical system operator (PSEF) platform that has obtained permission from the government,” she said.
Source: Antara News