Dietary supplements containing banned substances were found at pharmacies.
Specifically, on May 12, the Hanoi Center for Drug, Cosmetic and Food Testing inspected Duc Anh Pharmacy (Duc Anh Pharmaceutical and Medical Equipment Company Limited, Dong Da District, Hanoi) and discovered 7 types of drugs of unknown origin, without circulation registration numbers or import licenses.
In which, the medicine for treating gastric reflux NEXIUM 40mg Enterik Kapli Pellet Tablet (Esomeprazole), batch number: 23H420, expiry date: 9.2027, has a test result of Esomeprazole content of 6.91mg (equivalent to 17.27% compared to the content stated on the label), is determined to be a counterfeit medicine.
Another drug sample that is not eligible for circulation is DIAMICRON MR 60mg (Gliklazid), batch number: 23F603, expiry date: 04.2026. Test results show that the Gliclazid tablet sample has a Gliclazid dosage of 42.5mg/tablet (70.83% compared to the content stated on the label).
At An An pharmacy (No. 153, residential group 14, Kien Hung ward, Ha Dong, Hanoi ), the authorities also discovered that the drug Theophylline Extended Release 200 mg (Theophylline 200mg); batch number 21127, production date February 26, 2022, expiration date February 26, 2026; place of manufacture Pharmacy Laboratories Plus, was fake because it only had 6.3% of the declared active ingredient content. The medicine bottle did not have a Vietnamese sub-label and the place of manufacture was unknown.
Not only drugs, functional foods sold in pharmacies are also a matter of concern. Nhat Ngan Pharmacy (Lot 13, Cho Gao Commercial Center, Cho Gao District, Tien Giang ) was discovered selling a sample of Hong Hac Phuc Linh weight loss capsules containing the banned substances Sibutramine, Desmethylsibutramine and Didesmethylsibutramine, which have been banned from use in food due to the risk of harm to health.
Previously, many functional foods containing the banned substance Sibutramine were discovered to be sold at pharmacies such as the health protection food TIGI MAX PLUS (Nhat Tan pharmacy, 115 Tran Hung Dao, Ward 1, Tuy Hoa, Phu Yen) or Loss Weight Phuc Linh Collagen (Thien An pharmacy, Hung Vuong street, Ward 2, Trang Bom town, Dong Nai).
Reasons for counterfeit goods containing banned substances appearing in pharmacies
According to current regulations, functional foods are classified into 4 groups: dietary supplements, health protection foods, medical nutritional foods and foods for special diets.
Mr. Chu Quoc Thinh, Deputy Director of the Department of Food Safety (Ministry of Health), said that in the group of food supplements, the self-declared dossier only controls the testing of safety indicators. The two groups of medical nutritional foods and foods for special diets have not been controlled for quality. Only the group of health protection foods is controlled for quality indicators, "however, the dossier for registering the declaration is also very simple".
Due to resource constraints, not all health food products are inspected after being released from the factory and put on the market (post-inspection). Not to mention, many manufacturers take advantage of loopholes in the announcement mechanism, self-announce functional foods to "dodge" and mix in products that do not ensure quality, even contain banned substances, to put on the market.
Mr. Ta Manh Hung, Deputy Director of the Department of Drug Administration (Ministry of Health), stated that the fact that pharmacies buy and sell without invoices and documents and of unknown origin is the main reason why counterfeit drugs enter the legal distribution system. In addition, many facilities do not comply with regulations on storage and purchase from licensed suppliers, increasing the risk of reduced drug quality.
In addition, the current penalties are not enough of a deterrent. Mr. Hung gave an example: subjects will only be criminally prosecuted if they produce or trade counterfeit goods (including drugs) worth VND30 million or more.
The penalty for trading in counterfeit goods based on the value of the goods is too low because the value of the medicine at retail establishments is usually low (under 1 million VND). For example, a business selling fake Clorocid TW 3 medicine only displays 2-3 bottles, each bottle costs about 30,000 VND. If discovered, the establishment will only be fined from 2 to 6 million VND.
Pharmaceutical businesses with goods of unknown origin and value under 1 million VND will only be subject to a warning or a fine of 600,000 VND to 1 million VND; the exhibits will be returned or destroyed.
Tighten control and increase sanctions
Deputy Minister of Health Do Xuan Tuyen affirmed at the workshop "Counterfeit Medicines - Real Consequences" that medicines and functional foods are special products that directly affect people's health, and there needs to be strong enough sanctions to deter the production and trading of counterfeit goods.
The Ministry of Health has reported to the Prime Minister and received approval to increase administrative and criminal penalties for the production and trade of counterfeit drugs and functional foods. At the same time, the Food Safety Department is drafting a revision to Decree 15/2018 to strengthen post-inspection and overcome current loopholes.
Deputy Director of the Food Safety Department Chu Quoc Thinh said that this agency is consulting and proposing to apply a control model similar to the US Food and Drug Administration (FDA) and some other countries, which is strict pre-checking of records, regular post-checking, and surprise post-checking.
That is, after the enterprise announces the product, the authorities will have to proactively review the documents and take market samples to check the actual quality, especially with health food products.
At the same time, we will step up surprise inspections based on feedback from consumers, the press or authorities. The testing system will also be tasked with proactively monitoring the market, instead of just checking on orders as it is now.
TH (according to Vietnamnet)
Source: https://baohaiduong.vn/lien-tiep-phat-hien-thuoc-gia-thuc-pham-chuc-nang-chua-chat-cam-tai-nha-thuoc-412946.html
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