Agency reaffirms drug syrups for children as informed by WHO

Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (BPOM) has reaffirmed that the drug syrups for children mentioned in the information from WHO consist of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

The statement was made in connection with media reports on the issue of syrups for children at risk of containing Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination, according to an official statement from BPOM received here on Thursday.

BPOM conducts comprehensive pre- and post-market supervision of medicinal products circulating in Indonesia, and in accordance with the regulations and requirements for registration of medicinal products, the agency has set a requirement that all drug syrup products for children and adults are not allowed to use EG and DEG.

However, EG and DEG can be found as contaminants in glycerin or propylene glycol which are used as additional solvents, and BPOM has set a maximum limit for EG and DEG on these two additives according to international standards.

The Ministry of Health has explained that the cause of the Acute Kidney Injury (AKI) is unknown and still requires further investigation with BPOM, the Indonesian Pediatrician Association (IDAI), and other related parties.

BPOM encourages health workers and the pharmaceutical industry to actively report drug side effects or unwanted events after drug use as part of preventing unwanted events that have bigger impacts.

BPOM also coordinates intensively with the Ministry of Health, health service facilities, and other related parties in the context of monitoring the safety of drugs (pharmacovigilance) circulating and used for treatment in Indonesia.

In addition, BPOM conducts risk-based tracing, sampling, and gradual sample testing of syrup medicinal products that have the potential to contain EG and DEG contamination.

The results of product testing containing EG and DEG contamination still require further studies to ensure compliance with the safe threshold based on the reference.

Furthermore, for products that exceed the safe threshold, administrative sanctions shall be immediately given in the form of warnings, stern warnings, temporary cessation of drug manufacturing activities, freezing of good manufacturing practices certificates, revocation of the certificates, and suspension of advertising activities, as well as suspension of distribution permits and/or revocation of the permits.

All pharmaceutical industries which have syrups that have the potential to contain EG and DEG contamination are required to report the results of tests carried out independently as a form of responsibility of business actors, but they can also make other efforts such as changing drug formulas and/or raw materials if necessary.

On Wednesday, Oct. 12, 2022, BPOM gave an explanation regarding drug syrups for children contaminated with DEG and EG in Gambia, Africa.

Reporting by Indonesia Window