Indonesia’s food and drug agency on Wednesday revoked the licences of two chemical firms to distribute materials used in syrup medicines linked to a wave of child deaths caused by kidney failure or damage.
The move comes as the Southeast Asian country suffers a spike in cases of acute kidney injury that has killed nearly 200 children since the end of August, prompting an investigation and ban on the sale of some syrup medicines.
PT Mega Setia Agung Kimia and PT Tirta Buana Kemindo were barred from distributing raw pharmaceutical materials after two potentially harmful chemicals — diethylene glycol and ethylene glycol — were found in their supplies of propylene glycol, agency chief Penny Lukito told reporters.
The two chemical compounds are used in industrial products such as antifreeze and have been linked with recent cases of acute kidney injury.
Their distribution licences were revoked for “failing to comply with the requirements,” Lukito said.
“They distribute products contaminated with ethylene glycol and diethylene glycol. They also did not conduct inspection to guarantee the quality of the solvents,” said Lukito.
The food and drug agency (BPOM) also ordered the recall of syrup medicines from two other pharmaceutical companies — PT Samco Farma and PT Ciubros Farma — after tests revealed excessive amounts of those chemicals in their products.
“To those two firms, BPOM has ordered the recall of syrup medicines from distribution across Indonesia and the destruction of batches of products that contain ethylene glycol and diethylene glycol that were above safe levels,” Lukito said.
The agency on Sunday ordered the recall and destruction of syrup-based medicines from three other pharmaceutical companies after tests revealed the products contained ethylene glycol “beyond safe levels”.
Police have launched an investigation into the three companies and two of them have temporarily lost their licence to produce syrup medicines.
The World Health Organization has said it found an “unacceptable amount” of diethylene glycol and ethylene glycol in four Indian-made cough syrups and warned they could be linked to the deaths of nearly 70 children in Gambia due to AKI.