Indonesia revokes firms’ fever syrup licences amid inquiry into 150 deaths
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.
(Reuters)
Indonesia’s food and drug
agency has said it has revoked licenses 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 acute
kidney injury.
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Farmatama and PT Universal Pharmaceutical Industries, had been
revoked, adding BPOM was pursuing criminal action against them.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.
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.
READ MORE:
Indonesia bans deadly syrup ingredients linked to Gambia child deaths
Similar incident in Gambia
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 Organisation (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.
Read More: Is it time to ban the deadly chemical behind Gambia children deaths?
Source: Reuters
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.
(Reuters)
Indonesia’s food and drug
agency has said it has revoked licenses 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 acute
kidney injury.
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.
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.
READ MORE:
Indonesia bans deadly syrup ingredients linked to Gambia child deaths
Similar incident in Gambia
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 Organisation (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.
Read More: Is it time to ban the deadly chemical behind Gambia children deaths?
Source: Reuters
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