I think the predicament of acute kidney injury cases is a bitter experience that must be (addressed with punishment) that has a deterrent effectJakarta (ANTARA) - National Agency of Drug and Food Control (BPOM) Head Penny K. Lukito called for reinforcing legal sanctions, with a deterrent effect, on criminals amid acute kidney injury cases associated with syrup drug poisoning.
"I think the predicament of acute kidney injury cases is a bitter experience that must be (addressed with punishment) that has a deterrent effect," Lukito noted during a meeting with Commission IX of the House of Representatives, here on Wednesday.
Lukito noted that so far, all forms of law enforcement pertaining to drug and food products in Indonesia had always imposed probation for the perpetrators, as they had not been proven to take someone victim.
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"It is far from being sentenced to 10 years in prison as listed in Article 196 of the Health Act," she pointed out.
She said the agency and relevant authorities conducted an investigation into cases of acute kidney injury linked to the distribution of syrup drug products in Indonesia.
As a result, 198 syrup medicines from 63 pharmaceutical industries do not use Propylene Glycol (PG), Polyethylene Glycol (PEG), Sorbitol, and/or Glycerin/Glycerol, so they can be deemed safe to use as long as their usage is in accordance with the recommendation.
Moreover, the results of sampling and testing of five of the 38 samples (or 13 percent), that were proven to contain EG/DEG contamination exceeding the safe limit of 0.1 mg/ml were Termorex Syrup (Batch AUG22A06), Flurin DMP Syrup, Unibebi Cough Syrup, Unibebi Fever Syrup, and Unibebi Fever Drops, she remarked.
She noted that according to further investigation, of the 102 medicinal products reported by the Health Ministry, 23 products did not use PG/PEG, Sorbitol, and Glycerin/Glycerol; 71 products were tested and deemed safe to use according to recommended usage; while five products were tested to have been containing EG/DEG exceeding the threshold.
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The five products were deemed ineligible, as they did not meet the requirements. These include 2,930 bottles of Flurine DMP Syrup produced by PT Yarindo Farmatama, 44,992 kg of PG raw materials produced by DOW Chemical Thailand Ltd, 110,776 pcs of Flurine DMP Syrup packaging materials, and documents.
The agency also confiscated 13,409 bottles of 60 ml of Unibebi Fever Syrup, 25,897 bottles of 15 ml of Unibebi Fever Drops, 588,673 bottles of 60 ml of Unibebi Cough Syrup, 18 drums of PG raw materials produced by DOW Chemical Thailand Ltd, and documents from manufacturer PT Universal Pharmaceutical Industries.
"Currently, we are in the process of following up on Afi Farma's products through testing of three products -- Paracetamol Drops, Paracetamol Peppermint Flavor Syrup, Vipcol Syrup -- with EG/DEG content that exceeds the safe threshold," she noted.
The agency has imposed administrative sanctions through product withdrawals and destruction, temporary cessation of drug manufacturing and distribution activities, revocation of the certificate of Good Manufacturing Practice, as well as followed by revocation of the Marketing Permit Number.
She expects that the imposition of sanctions, with a deterrent effect, was carried out once a link was found between the patient and the medication, which did not meet the requirements, as this was a case that lead to acute kidney injury.
Lukito said that crimes revolving around the production of food and drugs should draw punishment with optimum sanction, as they were crimes against humanity.
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Translator: Andi Firdaus, Mecca Yumna
Editor: Fardah Assegaf
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