JAKARTA: Indonesia's food and drug agency said on Monday it had revoked licences for syrup-type drug production by two local firms for violating manufacturing rules, as it investigates the deaths of more than 150 children due to acute kidney injury (AKI).
The decision by the BPOM agency came after Indonesia temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in the AKI deaths, most of which were of children under five.
The two ingredients are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. Ethylene glycol and diethylene glycol can be toxic and lead to AKI.
BPOM chief Penny K. Lukito told reporters the "oral liquid" manufacturing licences of the two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, had been revoked, adding BPOM was pursuing criminal action against them.
Penny said the two firms produced drugs with substandard raw materials, failed to report a change in ingredients and used some materials in excess of guidelines.
PT Yarindo Farmatama in a statement denied using substandard raw materials in their products and said BPOM approved changes in their ingredients in 2020 and that there were no problems with its distributor.
A lawyer with PT Universal Pharmaceutical Industries declined to comment, citing the ongoing investigation.
Indonesia has seen a surge in AKI cases among children since August, which its health minister said was most likely due to changes in the raw ingredients used in cough and fever syrups.
Indonesia imports its raw ingredients for medicine mostly from China and India, according to the health ministry.
Indonesian health authorities said solvents used in the syrups from the two companies contained impurities.
BPOM said on Monday one of these solvents, propylene glycol, was made by Dow Chemical Thailand.
Dow Chemical Thailand said in a statement that "none of the suppliers mentioned by BPOM are our customers", and that its product does not contain ethylene glycol or diethylene glycol. It said it had submitted analytical data to the BPOM.
BPOM said it would look into distributors of the two drug makers to see if they supplied materials to other pharmaceutical firms.
Indonesia has been investigating AKI cases in consultation with the World Health Organization (WHO) after a similar incident in Gambia earlier this year, which has seen at least 70 deaths related to syrup medications made by India's Maiden Pharmaceuticals.
Reuters
Tue Nov 01 2022
The decision by the BPOM agency came after Indonesia temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in the AKI deaths. - REUTERS
UPNM cadet officer charged with injuring junior, stomping on him with spike boots
A cadet officer at UPNM pleaded not guilty to a charge of injuring his junior by stomping on the victim's stomach with spike boots.
How Indian billionaire Gautam Adani's alleged bribery scheme took off and unraveled
The indictment was unsealed on Nov. 20, prompting a $27 billion plunge in Adani Group companies' market value.
Elon Musk blasts Australia's planned ban on social media for children
Several countries have already vowed to curb social media use by children through legislation, but Australia's policy could become one of the most stringent.
Trump picks Pam Bondi for US Attorney General after Gaetz withdraws
Bondi was the top law enforcement officer of the country's third most populous state from 2011 to 2019, and served on Trump's Opioid and Drug Abuse Commission during his first administration.
Ringgit extends uptrend against greenback in early trade
At 8 am, the local currency climbed to 4.4600/4700 against the greenback.
Lebanon's only burn unit treats toddlers after Israeli strikes
The hospital hallways echo with the screams of children as anxious parents await news from doctors.
AI revolutionising sports to develop world-class athletes
Can a young Orang Asli child from Gua Musang, Kelantan be turned into an Olympic champion in 2036?
Selangor records 1,354 out-of-wedlock teen pregnancies from 2023 to Sept 2024
Anfaal Saari emphasises the seriousness of the issue, especially involving children and teenagers under 18 years old.
ICC issues arrest warrants for Netanyahu and Gallant
The International Criminal Court (ICC) has issued arrest warrants for Israeli Prime Minister Benjamin Netanyahu and former Defense Minister Yoav Gallant.
Elon Musk's Neuralink receives Canadian approval for brain chip trial
The study aims to assess the safety and initial functionality of its implant which enables people with quadriplegia.
Guitar bought by Beatles' teenage Harrison for GBP58 sells for more than GBP1 million
A guitar bought by George Harrison for about GBP58 has sold at auction for more than GBP1 million (US$1.27 million), the PA Media news agenc
Duct-taped banana goes for $6.2 mln in Sotheby's art auction
A piece of art that is little more than a banana duct-taped to a wall sold at auction to cryptocurrency entrepreneur.
Australian teen dies from tainted liquor in Laos; fourth suspected victim
Spurious liquor is a problem in Laos, with the govts of Australia and Britain warning citizens to be cautious when taking drinks there.
Woman found in freezer died from chest injuries - Police
Preliminary post-mortem report reveals that the victim died from chest injuries caused by blunt trauma.
Malaysia, Vietnam to further cooperate in multiple sectors - PM
Datuk Seri Anwar Ibrahim says the collaboration will also leverage the ASEAN Energy Grid to foster regional growth.
Australia launches 'landmark' bill to ban social media for children under 16
Australia plans to trial an age-verification system that may include biometrics or govt identification to enforce social media age cut-off.
Court orders PDRM to complete investigations into Beng Hock's death within six months
Judge says the claims and reliefs sought by the applicants are within the domain of public law both in pith and substance.
Zii Jia secures spot in BWF World Tour Finals
This will be Lee Zii Jia's third appearance at the season-ending tournament, following the 2020 and 2021 editions.
PM: Media freedom recognition needs improvement but 3Rs limit action
Datuk Seri Anwar Ibrahim says this stems from a request by the Malay rulers for the government to take a stricter stance on these matters.
Malaysian man to be publicly caned at mosque for Islamic crime of close proximity
This punishment involves caning, but what makes it unusual this time is the judge's decision for it to be conducted publicly.