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More than 27,000 Zovitit pills destroyed due to quality violations

Báo Đầu tưBáo Đầu tư02/11/2024

The Ministry of Health Inspectorate also forced SC Slavia Pharma SRL to destroy 27,580 Zovitit pills that violated level 2 quality.


Medical news October 28: More than 27,000 Zovitit pills destroyed due to quality violations

The Ministry of Health Inspectorate also forced SC Slavia Pharma SRL to destroy 27,580 Zovitit pills that violated level 2 quality.

Fines and destruction of drugs due to quality violations

The Inspectorate of the Ministry of Health has just decided to administratively fine SC Slavia Pharma SRL Company (Romania) 70,000,000 VND for committing the following administrative violation: Manufacturing Zovitit tablets, GĐKLH number: VN-15819-12, batch number: 0017, NSX: 03/05/23, HSD: 02/05/26, violating level 2 quality according to the provisions of law.

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The above behavior violates the provisions of Clause 5, Article 4 and Point b, Clause 4, Article 57 of Decree 117/2020/ND-CP dated September 28, 2020 of the Government regulating administrative sanctions for violations in the health sector.

The Ministry of Health Inspectorate forced the company to destroy 27,580 Zovitit pills that violated the above-mentioned level 2 quality standards, produced by SC Slavia Pharma SRL (Romania) and imported by Cudopha Pharmaceutical Joint Stock Company.

Along with the fine of 70 million VND, the Ministry of Health Inspectorate also forced SC Slavia Pharma SRL to destroy 27,580 Zovitit pills that violated level 2 quality.

The Inspectorate of the Ministry of Health requires SC Slavia Pharma SRL (Romania) to strictly comply with this penalty decision. If SC Slavia Pharma SRL (Romania) fails to voluntarily comply within the deadline, it will be forced to comply according to the provisions of law.

Zovitit is a drug indicated for the treatment of Herpes simplex virus infection, prevention of genital Herpes reinfection, immunodeficiency...

Nearly 800 domestic drugs and ingredients have had their circulation registrations extended by the Ministry of Health.

The Drug Administration of Vietnam (Ministry of Health) has just extended the validity of 771 domestically produced drugs and pharmaceutical ingredients.

Of these, 556 domestically produced drugs and pharmaceutical ingredients have their circulation registration certificates extended for 5 years; 159 domestically produced drugs have their circulation registration certificates extended for 3 years; 56 domestically produced drugs have their circulation registration certificates extended until December 31, 2025.

The domestically produced pharmaceutical products and pharmaceutical ingredients whose circulation registrations have been extended this time are quite diverse in terms of pharmacological effects such as drugs for treating respiratory tract infections; drugs for treating osteoarthritis; drugs for treating cardiovascular diseases, hypertension, diabetes, cancer treatment, antiviral drugs, antibiotics, pain relievers, anti-inflammatories, etc.

There are products in the form of film-coated tablets, external solution, hard capsules, powder for suspension, dispersible tablets...

The Drug Administration of Vietnam requires that drug manufacturing and registration establishments are responsible for manufacturing and supplying drugs to Vietnam in accordance with the records and documents registered with the Ministry of Health and must print or affix the registration number issued by the Ministry of Health on the drug label;

At the same time, update the quality standards of drugs according to the provisions of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health regulating the quality of drugs and pharmaceutical ingredients, Circular No. 03/2020/TT-BYT dated January 22, 2020 of the Minister of Health amending and supplementing a number of articles of Circular 11/2018/TT-BYT regulating the quality of drugs and pharmaceutical ingredients.

Drugs whose circulation registration certificate has been extended under this Decision but have not yet submitted a dossier to update the content of the drug label and instructions for use according to the provisions of Circular 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health must update according to the provisions at Point b, Clause 1, Article 37 of Circular No. 01/2018/TT-BYT within 12 months from the date of extension of the circulation registration certificate.

Within 12 months from the date of renewal of the circulation registration certificate according to this Decision, if there is any change in administrative content, the product must be produced and circulated with the approved changes in the renewal dossier.

Drug registration facilities must ensure that operating conditions are maintained during the validity period of the drug and drug ingredient circulation registration certificate.

Nearly 160,000 people die from stroke due to cerebral embolism and cerebral hemorrhage

Prof. Dr. Do Doan Loi, Vice President of the Cardiology Association, said that according to the World Health Organization (WHO), in 2020, nearly 160,000 people in Vietnam died from stroke due to cerebral embolism and cerebral hemorrhage.

Typically, 2 out of 3 people with ischemic stroke will die or have severe sequelae requiring care within 5 years of the stroke.

With hemorrhagic stroke, 3 out of 4 people die or are left with complications, requiring care for many years. With myocardial infarction, the survival rate is only about 60% and also leaves a state of disability, causing a burden on the family and society.

Alarmingly, stroke and heart attack patients are getting younger. 20% of heart attack patients worldwide are under 40 years old.

In Vietnam, specialized cardiovascular and stroke hospitals have recorded many patients between the ages of 20 and 30 who have suffered strokes and heart attacks.

The reason is that today's youth are living according to "trends", eating a lot of fast food, addicted to cigarettes, drinking a lot of alcohol, beer, stimulants, carbonated soft drinks, using phones and computers constantly, living a hurried, stressful life and little exercise. These are risk factors leading to stroke and heart attack.

Giving advice to young people, Professor Do Doan Loi said that to live a healthy life, one must determine the balance between work and life. Avoid alcohol, tobacco, and increase physical activity.

According to experts, the main risks of cardiovascular diseases in Vietnamese people are ranked from high to low, including high blood pressure, smoking, high blood sugar, high blood fat and obesity.

Thus, for Vietnamese people, improving the condition of high blood pressure, diabetes, hyperlipidemia, obesity...; not abusing alcohol, not smoking, controlling reasonable weight, exercising and doing appropriate physical exercise will help reduce the risk of cardiovascular diseases.

According to WHO, stroke and heart attack have a very high incidence, but the vast majority of the main risk factors that cause these two diseases are preventable.



Source: https://baodautu.vn/tin-moi-y-te-ngay-2810-tieu-huy-hon-27000-vien-thuoc-zovitit-do-vi-pham-chat-luong-d228496.html

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