Directive No. 03/BYT-CT on handling violations related to the production and sale of counterfeit drugs

DIRECTIVE

Regarding the handling of violations related to the production and sale of counterfeit drugs
dealing in counterfeit drugs

After more than one year of implementing Circular Joint Ministry of Health - Interior No. 27/TT-LB dated December 24, 1990, based on reports from 48 localities, the Ministry finds that the handling of violations related to the production and sale of counterfeit drugs by most localities is unreasonable, ineffective for deterrence and education; this is reflected in the following statistical data:

Number of provinces reporting handling for ten months in 1991: 24

Number of cases handled: 366

1. Prosecution: 2.5%

2. Revocation of practice certificates: 7.6%.

3. Administrative fines: 79.2%

4. Released without action: 10.7%

And in some localities, there are difficulties and confusion in handling seized items: sometimes there are legal loopholes. To address these issues, the Ministry instructs the Departments of Health to implement regulations regarding the handling of violations related to the production and sale of counterfeit drugs as follows:

1. All cases with sufficient evidence of violations related to the production and sale of counterfeit drugs must be documented in a record, strictly and equally processed regardless of the economic component involved: state-owned, collective, private... no case can be overlooked; after processing, a report must be submitted to the higher health authority for monitoring and guidance.

1.1. For all cases of violations involving counterfeit drugs, the first step in handling is the revocation of the practice certificate (issued by the Department of Health). For staff in state-owned units and facilities, they shall not engage in work related to drugs: permanently or for at least six months.

1.2. Administrative penalties shall be imposed according to current national, ministerial, or provincial People's Committee documents.

1.3. If there are sufficient elements constituting a crime, prosecution under the Criminal Code shall be initiated.

Thus, there will be no internal handling or overlooking of any case.

2. In cases requiring prosecution under the Criminal Code:

2.1. Transfer the specialized dossier on pharmaceuticals to the investigative agencies (with a handover record).

2.2. Report the developments of the case to the Ministry for monitoring and guidance.

3. To enhance deterrent and educational effects and publicize to the people, all cases must be announced in newspapers, radio stations, and local authorities; avoid situations where a practice certificate has been revoked but the business license remains valid and the entity continues to operate normally.

4. Handling of seized items:

4.1. Take samples and store them according to regulations; these stored samples must be kept by responsible agencies until the criminal case or decision on handling becomes invalid.

4.2. The remaining seized items shall be disposed of by the Director of the Department of Health in accordance with regulations:

If they are counterfeit drugs: organize destruction, supervised by designated responsible officials by the Director.

If they are mislabeled drugs, drugs without registration numbers, drugs without original labels, drugs without manufacturing addresses... but whose internal quality can still be used, send them for testing; if they meet requirements, process or dispose of them according to regulations, ensuring safety and strict legality.

During examination and handling, one must thoroughly understand laws and regulations and act justly and impartially.

5. Based on reports from many localities, the Ministry observes that the implementation of national and ministerial regulations on preventing counterfeit drugs is not strict enough, leading to repeated occurrences of counterfeit drug incidents (75% of counterfeit drug samples detected were purchased from domestic unregulated sources), which could have been avoided. Now, the Ministry reminds localities to develop detailed plans to disseminate current regulations on preventing counterfeit drugs and inspection and supervision plans for all healthcare facilities, and cooperate with market management teams in the free market throughout the locality, focusing on district and commune levels.

5.1. Prohibit purchasing drugs from unregulated domestic sources; purchase drugs only from legitimate trading units and establishments with invoices issued by the Ministry of Finance and containing control numbers (batch numbers).

5.2. Strengthen management measures: Labels and packaging materials from printing to sale (must tear off labels), equipment and devices used in drug production.

5.3. Prohibit the sale of drugs without original labels, drugs without manufacturing addresses; drugs without registration numbers; consigned drugs of unknown origin.

5.4. Hospitals, companies, and factories' drug warehouses must regularly inventory and verify drugs, closely monitor control numbers and registration numbers, and complete inventory and verification records.

Upon receipt of this Directive, it is requested that the Directors of the Departments of Health and heads of subordinate units fully convey the spirit and content of this Directive to quickly restore order in the drug market and prevent counterfeit drugs according to Circular Joint Ministry of Health - Interior No. 27/TT-LB dated December 24, 1990, achieving effectiveness in protecting users' rights and regaining public trust in medicinal products.