Suspending a series of imported drugs violating quality
A series of drugs imported into Vietnam
Imported drug alarm
In the 4 latest documents on suspension of drug circulation due to failure to meet quality standards of the Drug Administration, 3 documents are related to drugs of Indian origin (including Cetirizine Hydrocholoride 10mg, LODIPINE-C (Amlodipine Besylate Tablets) 5mg and Paracetamol Infusion 10mg/ml).
The remaining recalled product is Daehwa Albendazole 400mg film-coated tablets, Registration number: VN-8648-09, Batch number: 2018; Expiry date: August 29, 2015, manufactured by Daehwa Pharmaceuticals, Korea, imported by TW3 Pharmaceutical Company Limited.
Imported drugs are suspended and recalled due to poor quality.
Previously (from July 8 to July 24), there were 4 other drugs that were suspended from circulation because they did not meet quality standards, including 2 from India, 1 from the US and 1 from Korea. The rate of imported drugs that were suspended from circulation is also increasing, notably drugs from India.
Specifically: Of the total 17 drugs recalled from the beginning of 2013 until now, imported drugs dominate with 12 types (of which Indian drugs have up to 8 types), and Vietnamese drugs have 5 types.
In 2012, of the 47 drugs that violated quality, 20 drugs originated from Vietnam, 22 drugs originated from India, and the rest were drugs from other countries.
In 2011, among 72 drugs violating quality, 26 drugs originated from India, 36 drugs originated from Vietnam (accounting for 50%), and the remaining 10 drugs originated from other countries.
While Indian-origin drugs have encountered many quality problems and many have been recalled, what is worrying is that Indian drugs are flooding into hospitals (and the free pharmaceutical market in Vietnam).
According to statistics of Vietnam Social Security
Drugs originating from China are also in the top 5 drug suppliers to Vietnamese hospitals with prices much lower than drugs originating from other regions.
Only drugs that meet quality standards are allowed to be circulated.
Faced with the current situation of imported drugs being "alarming" in terms of quality, recently, Mr. Truong Quoc Cuong - Director of the Department of Drug Administration (Ministry of Health) signed and issued an important document to tighten the quality of imported drugs.
Accordingly, the Drug Administration requires drug importing companies to coordinate with the quality control system to inspect 100% of imported drug batches from companies on the list of foreign pharmaceutical companies with drugs violating quality before circulating them on the market.
Specifically: After the drugs are cleared through customs, they must be transferred to warehouses that meet the standards of "Good Storage Practices" (GSP). Drug importing companies must contact the provincial and municipal testing centers to collect samples for quality testing according to regulations to determine the quality of 100% of imported drug batches.
In addition, drug importing companies must send the collected samples to the Central Drug Testing Institute, Ho Chi Minh City Drug Testing Institute or provincial or municipal testing centers for quality testing and, together with drug suppliers, are responsible for providing standard substances, reference substances, and standard impurities for drug testing according to the requirements of the testing unit.
“Only batches of drugs that have been sampled and tested to meet quality standards are allowed to be circulated and distributed. During the circulation process, drug quality must continue to be monitored and supervised according to regulations.”, Mr. Cuong said.
In addition to the responsibility of drug importing companies, the Drug Administration also requested the Central Institute for Drug Testing, the Ho Chi Minh City Institute for Drug Testing and the Testing Centers of provinces and cities to take action to tighten the quality of imported drugs by testing the quality of drugs sent by importing companies before they are put into circulation, distribution and use.
In addition, the Department of Health of provinces and centrally run cities and the Health Departments of all sectors need to inspect and supervise drug import companies located in the area to strictly carry out sampling and testing of drug quality before putting them into circulation, distribution and use.
According to Vietnam.net- DP
