Serang. The Drug and Food Supervisory Agency, or BPOM, on Monday made a shocking revelation that a pharmaceutical company based in the Banten capital of Serang has used ethylene glycol (EG) 100 times the safe limit in its paracetamol syrup.
The company is one of three drug producers currently under police investigation for allegedly producing syrup medicines tainted with harmful chemicals.
Speaking at a press conference in Serang, BPOM Head Penny Lukito said the agency has been collaborating with the National Police since last week to investigate the “tragic and saddening conditions” of rampant acute kidney injury that has “claimed so many lives of Indonesian children” in the past 10 months.
“There is an indication of a link to the consumption of child syrup medicines containing or having a high concentration of ethylene glycol or EG and diethylene glycol or DEG due to the use of a solvent called propylene glycol,” Penny said in the conference streamed live on the agency’s YouTube channel.
She mentioned the three pharmaceutical companies by name: Yarindo Farmatama, Universal Pharmaceutical Industries, and Afi Farma Pharmaceutical Industries.
Penny said the allowable amount of ethylene glycol is less than 0.1 milligrams per milliliter but Yarindo's Flurin DMP paracetamol syrup contains "almost 100 times the safe limit.”
Product description from online drug stores describes Flurin DMP as a paracetamol syrup to treat cold symptoms priced at just $2.5 per bottle of 60 milliliters.
Crime against Humanity
Universal, a company based in the North Sumatra capital of Medan, has had its three syrup medicine products recalled for being tainted with ED and DEG above the safe limit since 10 days ago.
Penny said that a high concentration of EG and DEG is toxic for humans.
Syrup medicines manufactured by Yarindo and Universal were certified by the BPOM but Penny said the drug makers have made significant changes in terms of quantity, composition, and character of the materials used from the pharmaceutical grades imposed by the agency.
They also “switched suppliers” disregarding necessary qualifications and dangerously “skipped quality control” steps on incoming materials in blatant violations of BPOM’s standard procedures, she said.
“Any change should have been first reported to the BPOM,” Penny said.
The joint operation of the BPOM and the police’s criminal investigation agency (Bareskrim) found indications of criminal offenses by Yarindo and Universal such as the manufacture and distribution of harmful pharmaceutical products regulated under the 2009 Health Law and a violation of the Consumer Protection Law with a maximum punishment of 10 years in prison and a fine of Rp 2 billion ($128,000).
“If there is a link to the death toll [in acute kidney injury cases], there will be different risks of sentences for certain,” Penny said.
She underlined that food and drug-related crimes that cause great suffering to the community can be classified as a “crime against humanity”.
“In the latest development, we found indications that new paracetamol producer Afi Farma may have committed a criminal offense by using EG and DEG above the permitted amount,” she said.
“There are seven Afi Farma products containing chemicals above the limit and we decided to hold its entire syrup medicines for children.”
In addition to the ongoing criminal investigation, the three companies have been slapped with “administrative sanctions” including discontinuation, recall, and destruction of their tainted products.
Penny said the joint investigation won’t stop at the three companies but will trace down to the supply chains, adding that the BPOM and the police have seized more than 80 drums of the chemicals from their suppliers.
“We need to do this to have a deterrent effect, to prevent a recurrence,” she said.
After the blanket ban on all syrup medicines imposed on October 20, Penny said 102 products are now declared safe for not containing chemical solvent, so are around 60 other products with chemicals within the safe limit.
Brig. General Pipit Rismanto, a Bareskrim director who leads the police investigation, vowed a transparent and thorough investigation into the case, including the suspected link to the growing number of cases and deaths of children with acute kidney injuries.
“We will investigate if there is intentional action or negligence that led to this tragedy,” he said at the same conference.
Universal Pharmaceutical Industries has denied any wrongdoing, saying on Sunday it has “no sinister intention” to pose health risks among children.
“We have no sinister intention at all. The company is working cooperatively with the BPOM to trace the source of the said contamination,” Hermansyah Hutagalung, an attorney for Universal, said in a press statement.
Hermansyah said the chemicals were imported from a certified foreign supplier but he didn’t go into details pending an internal investigation.
A lawyer for Yarindo said on Saturday the company has been in the business for 20 years without problems and complaints from consumers.
"We need to clarify that Flurin DMP doesn't contain ethylene glycol and diethylene glycol which are harmful to human health. From all media reports that we have learned, not a single acute kidney injury victim has consumed Flurin DMP," Yarindo legal affairs manager Vitalis Jebarus was quoted by Antara as saying.
The Jakarta Globe cannot immediately reach representatives from Afi Farma for comments.
Indonesia has recorded 269 cases of children with acute kidney injuries and 157 deaths during the past 10 months, according to the latest government data. The number of hospitalized children with AKI has been falling sharply since the ban on syrup medicines was imposed, Health Minister Budi Gunadi Sadikin said on Sunday.