What is Counterfeit Medicine?

Fake drugs are defined at Clause 33, Article 2 of the Pharmaceutical Law 2016 using the listing method. Specifically, fake drugs are those manufactured under one of the following circumstances:

- Without medicinal substances or ingredients;- Containing medicinal substances that do not match those listed on the label or according to the registered circulation standards or stated in the import license;- Containing medicinal substances or ingredients but not in the registered quantities, concentrations, or weights, except for drugs that do not meet quality standards as prescribed in Clause 32, Article 3 of the Pharmaceutical Law 2016 during the process of preservation, circulation, and distribution;- Produced, presented, or labeled to impersonate the manufacturer, country of manufacture, or country of origin.

Previously, the Pharmaceutical Law 2005 (effective from October 1, 2005, to December 31, 2016) also defined fake drugs (Clause 24, Article 2). Accordingly, fake drugs are products manufactured in the form of drugs with fraudulent intent, falling into one of the following cases:

- Without medicinal substances;- Containing medicinal substances but not in the registered amount;- Containing medicinal substances different from those listed on the label;- Imitating the name or industrial design of drugs registered for intellectual property protection by another manufacturer.

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According to the current criminal law regulations (Ciminal Code 1999), the act of manufacturing and trading fake drugs, if constituting a crime under Article 157 of the Ciminal Code 1999, can be punished by imprisonment ranging from a minimum of 2 years to a maximum sentence of death for the crime of producing and trading fake medicinal drugs causing particularly serious consequences. In addition, the offender may also face supplementary penalties such as fines from 5 million VND to 50 million VND, confiscation of part or all of their property, and a ban on holding certain positions, practicing specific professions or conducting certain jobs from 1 year to 5 years.

Furthermore, the Ciminal Code 2015 (effective from January 1, 2018) has specific provisions on the crime of producing and trading fake medicinal drugs with the highest penalty being the death sentence, and the legal entity committing this crime can face fines ranging from 1 billion VND to 20 billion VND and may be permanently suspended from operations.

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