Urgent Need for Better Pharmaceutical Oversight

BADAN POM

Food and Drug Supervisory Agency (BPOM) head Penny K Lukito.

JAKARTA, KOMPAS — A comprehensive transformation needs to be carried out on the quality assurance system for pharmaceutical products in Indonesia. The existence of loopholes in drug control regulations makes the monitoring system suboptimal. This change is increasingly urgent so that cases of acute kidney disorders in children do not recur.

Food and Drug Supervisory Agency (BPOM) head Penny K Lukito said this at a press conference on the results of the prosecution of drug syrup manufacturers that did not meet standards, in Serang, Banten, on Monday (31/10/2022).

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At least three pharmaceutical companies were cited by BPOM as producing non-standardized medicinal syrups, namely PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT Afi Farma Pharmaceutical Industries.

“This tragedy [a number of cases of acute kidney injury in children] has forced us to immediately improve the quality safety assurance system and provide a deterrent effect for [would-be] offenders so that it does not happen again. Drug crime exists and [offenders] will take advantage of various opportunities and gaps," she said.

Sanctions are generally only about three months and a probationary period. Therefore, it must be more forceful.

So far, the prosecution of violations of the safety and quality assurance of pharmaceutical products has not had a deterrent effect. Sanctions are generally only about three months and a probationary period. Therefore, it must be more forceful.

According to Penny, the regulation on the entry of raw materials for the pharmaceutical industry does not require BPOM certificates. The absence of this legal umbrella makes it difficult for BPOM to monitor the entry of raw materials from the start.

KOMPAS/RIZA FATHONI

Minimarket shop workers in the Kramat area, Jakarta withdrew a syrup drug product containing paracetamol, on Thursday (20/10/2022).

“So it is impossible to differentiate the procurement of raw materials or solvents in the form of PEG and EG (polyethylene glycol and ethylene glycol) from pharmaceutical grade and industrial grade. They utilized this," she said.

Not ready

The large number of cases and fatalities due to acute kidney injury in children shows the unpreparedness to deal with poisoning. Given the additional threats of poisoning from chemicals and venomous animals, emergency specialist and Toxynologi Indonesia president Tri Maharani emphasized that Indonesia needed to have a poison control center that monitored, detected and responded quickly to problems.

The delay in responding to toxins in medicinal syrups that triggered acute kidney injury shows the country’s unpreparedness to mitigate poisoning. In addition to late detection, Indonesia also has had to rely on antidotes from abroad to handle it.

The Health Ministry previously said cases of atypical progressive acute kidney disorders in more than 200 children in Indonesia were suspected to be due to the consumption of medicinal syrups with ethylene glycol (EG) and diethylene glycol (DEG) exceeding the safe limit. EG and DEG compounds are prohibited from being included in drugs or food. The compounds were found as a contaminant of propylene glycol, polyethylene glycol, sorbitol and glycerin/glycerol compounds as an additional solvent for drug syrups.

The contamination is considered not to cause adverse effects if it is below the specified tolerance value.

According to the regulations of Farmakope Indonesia and the US Pharmacopeia, the two compounds were in the form of contaminants in syrup additives with a tolerance value of 0.1 percent in glycerin and propylene glycol, and 0.25 percent in polyethylene glycol. The contamination is considered not to cause adverse effects if it is below the specified tolerance value.

According to Penny, the EG content in products manufactured by PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT Afi Farma Pharmaceutical Industries is much higher than the safe limit. The 60 ml Flurin Dmp Syrup product produced by PT Yarindo Farmatama even uses propylene glycol as the raw material and is 48.29 percent EG.

“This means that it is no longer pollution, but from the source of raw materials containing very high EG and DEG ingredients. This is poisoning from raw materials,” she said.

Similar violations were found in drugs made by PT Universal Pharmaceutical Industries and PT Afi Farma Pharmaceutical Industries. At PT Afi Farma Pharmaceutical Industries, seven products containing EG exceeded the safe limit.

Investigations were carried out on the industrial raw materials. PT Yarindo Farmatama bought raw materials from distributor CV Budiarta, while PT Universal Pharmaceutical bought from PT Mega Setia.

"We are looking for the link between the two things to one source to see if there is an element of counterfeiting in the legal aspect. The source of the raw material for propylene glycol is by Dow Chemical Thailand," she said.

The director of specific crimes at the National Police’s Criminal Investigation Department (Bareskrim), Pipit Rismanto, said the investigation was carried out to find out whether the contamination was intentional or negligent. Samples of the patients’ medication, urine and blood were collected. Investigations were also carried out on the raw materials of the drugs used.

KOMPAS/NIKSON SINAGA

Medan City Government Health Service officers inspect syrup drugs that have been stored in a warehouse at a pharmacy on Jalan Setia Budi, Medan, North Sumatra, on Friday (21/10/2022).

Meanwhile, the president director and two managers of PT Universal Pharmaceutical Industries were examined at the BPOM Center in Medan, North Sumatra, yesterday. The company was investigated as a witness for allegedly producing Unibebi brand syrup that did not meet safety standards. The three people examined were president director Boedjono Muliadi, production manager Suherman and marketing manager Sugini.

“We support the BPOM inspection. Our client is still a witness,” said Hermansyah, PT Universal's attorney.

The company carried out laboratory tests to compare to the BPOM’s findings and the results confirmed that EG and DEG contamination exceeded the safe threshold in their products. (TAN/AIK/NSA)

(This article was translated by Hyginus Hardoyo)