Effective February 15, 2023, Kazakhstan has implemented new regulations pertaining to the state registration and re-registration of drugs containing paracetamol, media reports.
The updated guidelines permit mono-component preparations with a single dose not exceeding 500 mg in medicinal forms for ingestion and rectal suppositories with no more than 300 mg. Combined anticolates and anticough preparations with a single dose of not more than 500 mg are also permitted. However, combined anti-cold and anti-cough preparations containing paracetamol, in conjunction with caffeine, are not recommended for children under 12 years of age, pseudoephedrine, dextromethorphan, ephedrine, codeine, and children under 18 years of age.
The drugs containing paracetamol that do not comply with these regulations or those that contain ethyl alcohol in the adjuvants will not be approved for state registration or re-registration. The primary objective of these measures is to ensure that the handling of medicines is safe and to decrease the likelihood of adverse effects on the liver, kidneys and other undesirable effects that could potentially compromise the well-being and safety of individuals. These restrictions were based on the expert opinion of the National Center for Examination of Medicines and Medical Products concerning the use-risk ratio of drugs containing paracetamol.
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