Polish drug taken from market after casualties

Half of the Vietnamese pharma market is made up of imports, with most of them coming from the EU

The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH), made the move late last month after it was determined that several suspected incidents were caused by Bupivacaine WPW Spinal 0.5% Heavy, an anaesthetic produced by Polish group Polfa Warszawa S.A.

In the urgent dispatch sent to departments of health and hospitals nationwide, the DAV required them to stop the use of variants of the drug with registration No.VN-20879-17, and batches 04DB1119, 07DB0919, and 08DB0919, while waiting for further investigation results and seeking for alternatives.

“Manufacturing and trading units should find a substitution for bupivacaine-contained injected drugs in cases of necessity,” the dispatch stated.

The DAV also asked importer Central Pharmaceutical Company 1 JSC to check the distribution and use of the batches and inform relevant units of the suspension, while working with the producer and users on the cause of the deaths.

The announcement was made following a report by Binh Duong Department of Health about suspected bupivacaine poisoning cases in the province. It was reported in January that the DAV said several batches of Bupivacaine Heavy with the same registration number, produced by Polfa Warszawa, were qualified and safe to use.

However, five months later Quang Binh’s Department of Health was said to have received a report from the central province’s general hospital about a death suspected to be related to one of the batches.

These cases are not the first to bring the drug into question. In November 2019, two pregnant women in Danang died and one entered critical condition after receiving injections of an anaesthetic for caesarean section at the city’s Women’s Hospital. The hospital had carried out around 11,000 c-sections under anaesthesia in the previous decade with no complications, Danang Department of Health found after an initial investigation.

Since then, Hanoi and the provinces of Quang Ngai, Ben Tre, Long An, and others have raised the alarm after several patients fell into danger after having the drug administered.

Polfa Warszawa is one of Poland’s largest pharmaceutical companies and has been in business since 1824, but the cases have triggered public concerns over the quality of imported drugs as well as the way licences are granted by authorised agencies.

Drug imports to Vietnam now make up over 50 per cent of the country’s total demand, with the European Union being the biggest suppliers. According to the Ministry of Industry and Trade, this year Vietnam is estimated to import $6.23 billion in pharmaceutical products and materials for production, $3.5 billion of which will be finished medicine, up $400 million on-year.