Tracing the Origin of Medicinal Substances

The origin of medicinal substances containing ethylene glycol and diethylene glycol should be traced. The two chemicals are suspected of triggering atypical progressive acute kidney injury in children.

KOMPAS/SEKAR GANDHAWANGI

Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito (center, white mask) answers a reporter's question about drugs containing ethylene glycol and diethylene glycol contamination in Jakarta on Thursday (27/10/2022).

JAKARTA, KOMPAS— It is urgent to trace the origin of medicinal substances containing ethylene glycol and diethylene glycol contaminants. This is meant to reduce any future new cases of atypical progressive acute kidney injury in children.

The Food and Drug Authority (BPOM) Chief Penny K Lukito at a press conference in Jakarta on Thursday (27/10/2022) said two pharmaceutical industries were subjected to legal action by the National Police Criminal Investigation Agency. The medicines produced by both industries contain very high concentrations of ethylene glycol (EG) and diethylene glycol (DEG). EG and DEG are not allowed to be used for syrup drug production.

“EG and DEG might [be used to] serve as solvents [of syrup drugs]. We suspect there was an element of intent, so this falls within the criminal domain. We [need to] trace it even further,” said Penny. She was unprepared to mention the names of both companies being examined by the police.

EG and DEG have been found to be contaminants in polyethylene glycol, propylene glycol, sorbitol and glycerin/glycerol. The four compounds were used as additional solvents of liquid or syrup medicines. However, the four are not dangerous materials or prohibited in the production of drugs. The consumption of EG and DEG is only safe if it does not exceed their threshold, which is 0.5 milligram per kilogram of body weight per day.

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EG and DEG consumption beyond the threshold can cause health hazards. EG and DEG are suspected of inducing atypical progressive acute kidney injury that has affected hundreds of children in Indonesia over the last few months.

The origin of the medicinal substances used by the companies that are being probed by the police will also be traced and so will the grades of the basic substances. The basic substances allowed to be used for drug-making are required to meet pharmaceutical grades.

The chemical substances fulfilling pharmaceutical grades have been purified and are generally more expensive than chemicals of other standards, such as industrial standards. The price difference is feared to offer the chance for the use of illegal medicinal materials.

KOMPAS/YOLA SASTRA

Officers of the Food and Drug Authority (BPOM) Padang monitor drugs containing EG and DEG contamination which are suspected to be one of the triggers for acute kidney failure in children at the Musi Pharmacy in the warehouse area of Pasar Raya Padang, West Sumatra, Monday (24/10/ 2022).

Based on the Health Ministry’s website, 90 percent of medicinal substances are imported. But not all the imported basic substances are under BPOM supervision. According to Penny, the solvents of syrup drugs like propylene glycol and polyethylene glycol belong to the category of non-prohibited and unrestricted goods being supervised by the Trade Ministry.

“The import of basic substances meeting pharmaceutical grades is under the authority of the BPOM. These materials belong to the category of prohibited and restricted goods so that their import requires an SKI [certificate of import] from the BPOM. We will verify them first,” said Penny.

Pursuant to BPOM data, 65 liquid medicines are on the list of drugs that contain none of the four solvents, which are propylene glycol, polyethylene glycol, sorbitol and glycerin/glycerol. These medicines are declared safe for consumption. Several of them are Flagyl, Molexdryl, Obat Batuk Hitam and Zincpro. Their distribution licenses are owned by Aventis Pharma, Molex Ayus, Nusantara Beta Farma and Combiphar. The BPOM has released 198 drugs that are safe for consumption.

Increasing cases

Health Ministry spokesperson Mohammad Syahril said on 26 October 2022, 269 cases of atypical progressive acute kidney injury in children were recorded in 27 provinces. Of the total cases, 73 were under treatment, 39 recovered and 157 died.

“On 24 October 2022 there were 241 cases, so there was an increase of 18 cases. Of these 18 cases, only three were new. The other 15 cases were reported but they came up at the end of September [2022] to early or mid-October [2022],” said Syahril.

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The government has brought in Fomepizole antidotes for patients. Thirty antidotes were imported from Singapore in phases. Twenty antidote vials arrived in Indonesia on 10 and 18 October 2022 to cure patients in Cipto Mangunkusumo Central Hospital Jakarta. Ten other vials arrived on Thursday (27/10).

A total of 16 vials from Australia arrived on 22 October 2022 and were distributed to hospitals in Padang, Surabaya, Medan and Aceh. Syahril added that 200 Fomepizole vials would be imported from Japan and were slated to arrive next week.

This article was translated by Aris Prawira.