The letter was sent in response to concerns over a shortage of the drug which is an anti-coagulant and used in cardiothoracic surgery.

The DAV said that Protamine sulfate was listed as a rare drug, specified in Circular No 26/2019/TT-BYT issued on August 30, 2019, so it should be given priority in circulation.

However, no agency has applied for a certificate of circulation in Vietnam for drugs containing Protamine sulfate.

Recently, the DAV licensed some agencies to import injectable drugs containing Protamine sulfate to meet the treatment needs of hospitals. They included the Prosulf and Pamintu injection solution, both with 10mg/ml of Protamine sulfate.

Importers said that Protamine sulfate was imported based on the estimated quantity needed from hospitals. However, insufficient quantities will be imported into Vietnam due to high demand.

The main reason is that Protamine sulfate is a specialised drug and is only used in cardiac and thoracic surgery. Therefore, manufacturers usually produce to order.

Vietnamese importers, after receiving estimates from hospitals, sent the orders to foreign drug suppliers.

This could cause a temporary shortage as Vietnamese importers place orders, but foreign drug suppliers do not have enough of the drug in stock immediately. Waiting for production could take a few months.

Protamine sulfate is a rare drug and demand is low. In recent years, the DAV has asked departments of health, hospitals and importers to put orders on time and purchase the drug.

Protamine sulfate drug importers should compile the estimates provided by hospitals to make plans and sign contracts with foreign drug manufacturers and suppliers, avoiding drug shortages.

Drug importers will coordinate with hospitals to compile dossiers and orders to import Protamine sulfate drugs and submit the dossiers to the DAV immediately.

The DAV asked drug importers to report on import plans before Saturday (August 20). The plan must include detailed imported quantities and expected time of import, risks and supply shortages (if any) and propose solutions to avoid shortages.

The importers must also report to the DAV after these batches of drugs are imported to Vietnamese ports following Clause 21, Article 91 of Decree 54/2017/NĐ-CP about drug imports. 

Source: Vietnam News