BPOM Details Guidelines For Drug Syrup Consumption - BorneoTribun English

Wednesday, October 19, 2022

BPOM Details Guidelines For Drug Syrup Consumption

BPOM Details Guidelines For Drug Syrup Consumption
BPOM Details Guidelines For Drug Syrup Consumption.
Jakarta - The Indonesian Food and Drug Supervisory Agency (BPOM) conveyed guidelines for the public in consuming syrups that were safe to avoid harmful contaminants that can affect health.

"The public can use drugs appropriately and do not exceed the dose, read the warnings carefully, and avoid using leftover syrup that has been opened and stored for a long time," agency's Director for Drug Registration, Siti Asfijah Abdoellah, noted in a written statement  here, Wednesday.

In addition, the BPOM reminds consumers to consult with doctors, pharmacists, or other health workers if symptoms do not decrease after three days of consuming the drug syrup.

Abdoellah urged consumers to fully report the drugs used to health workers as well as report side effects of drugs to the nearest health worker or through the BPOM Mobile and e-MESO Mobile service applications.

Moreover, the public should exercise greater vigilance and use drug products registered with BPOM obtained from pharmaceutical service facilities or official sources and always remember to check the packaging, label, circulation permit, and expiry date before buying and consuming drugs.

She said that BPOM had banned the use of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in all syrup drug products' ingredients for children and adults.

"In accordance with the regulations and requirements for registration of medicinal products, BPOM has set a requirement that all syrup drug products for children and adults are not allowed to use EG and DEG," she emphasized.

Abdoellah remarked that EG and DEG can still be found as contaminants in additional solvents. The BPOM has set a maximum limit of EG and DEG on the two additives according to international standards.

The Ministry of Health stated that the cause of acute kidney injury (AKI) is unknown while highlighting the need for further investigation with BPOM, the Indonesian Pediatrician Association (IDAI), and other related parties.

The BPOM encourages health workers and the pharmaceutical industry to actively report drug side effects after drug use as part of preventing unwanted incidents that can lead to a bigger impact.

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

Abdullah noted that the results of product testing containing EG and DEG contamination still required further studies to ensure compliance with safe thresholds based on references.

Furthermore, products exceeding the safe threshold will receive administrative sanctions in the form of warnings, stern warnings, temporary cessation of drug manufacturing activities, freezing the Good Manufacturing Practices (GMP) certificates, revocation of GMP certificates, and temporary cessation of advertising activities, as well as suspension of marketing permits and/or revocation of distribution permit.

"The pharmaceutical industry can also make other efforts, such as changing drug formulas and/or raw materials if needed," Abdullah stated.

The BPOM had earlier delivered an explanation regarding drug syrup for children contaminated with DEG and EG in Gambia, Africa, on Wednesday, October 12.

The BPOM stated that the syrups for children mentioned in the information from WHO comprised Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, produced by Maiden Pharmaceuticals Limited, India.

The four products recalled in Gambia were not registered and were not circulating in Indonesia, and to date, none of the products from the manufacturer Maiden Pharmaceutical Ltd, India, are registered with BPOM.

Oleh : Andi Firdaus, Resinta S/Antara
Editor : Yakop



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