"The gap that we have found is that the raw materials used by the pharmaceutical industry are entering Indonesia without BPOM's supervision," the agency head remarked at a working meeting with Commission IX of the Indonesian House of Representatives (DPR RI) in Jakarta on Wednesday.
The raw material is called Propylene Glycol (PG) and Propylene Glycol (PEG) as solvent compounds commonly used in the food, cosmetic, textile, and pharmaceutical industries, she remarked.
Specifically, PG and PEG products for pharmaceutical needs must meet quality standards to obtain pharmaceutical-grade status. One of the indicators is the provision of a maximum safe threshold of 0.1 mg/ml, Lukito explained.
Another provision is the requirement for producers of medicinal raw materials to have a certificate of good medicine manufacturing practices (CPOB) from the BPOM.
According to Lukito, pharmaceutical-grade raw materials have a higher price than industrial-grade, as they must go through a high-level purification mechanism under the supervision of BPOM.
“This PG and PEG entered Indonesia through the Ministry of Trade through a non-ban and restriction mechanism and not through the BPOM Import Certificate (SKI),” she pointed out.
As a result of this method, the BPOM is unable to monitor the quality and safety of these raw materials when they entered Indonesia, she cautioned.
“This gap is used by criminals. Our investigation with the police to the importers and distributors of this solvent show there are indications of intentional changes in the source of raw materials that were not reported to BPOM,” she remarked.
Lukito has reported the situation to President Joko Widodo and related agencies regarding the requirement of PG and PEG solvent distribution to go through the BPOM SKI.
"The Trade Ministry said that these solvents were used by other industries, such as paints, textiles, and others. In fact, special pharmaceutical grades should be included in the BPOM SKI. However, so far, there are no regulations," Lukito stated.
As is known, the PG and PEG content that exceed the safe threshold can trigger kidney-damaging compounds called Ethylene Glycol (EG) and Diethylene Glycol (DEG).
EG and DEG can turn into small kidney-damaging crystals when processed by the human body's metabolism. This situation was then linked to cases of acute kidney disorders in Indonesia.
Under the same agenda, Indonesian Health Minister, Budi Gunadi Sadikin, reported that as of Tuesday, the number of cases of acute kidney disorders nationwide had reached a total of 325 cases. A total of 178 patients were reported to have died.
The highest number of cases were in Jakarta, West Java, East Java, Banten, Aceh, West Sumatra, and Bali.
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Translator: Andi Firdaus, Resinta S
Editor: Rahmad Nasution
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