Why is Valganciclovir banned by the state? Analysis of reasons and effects of banning

Valganciclovir is a nucleoside antiviral drug commonly used to treat and prevent cytomegalovirus (CMV) infection. It is particularly suitable for the treatment of CMV retinitis in HIV-infected patients and the prevention of CMV infection after organ transplantation in patients.

However, in recent years, the public has paid widespread attention to its "banned sale" issue. Especially in the drug supply in mainland China, some channels have experienced shortages or even been discontinued, which has led to misunderstandings about "whether Vancevir has been banned from sale." In fact, so far, valganciclovir has not been included in the clear "banned" list by the State Food and Drug Administration in China. The so-called "banned sales" are mostly due to issues with market supply, production policy or import licensing, rather than based on the safety of the drug itself.

Overseas data shows that valganciclovir is still one of the main recommended drugs for CMV treatment in European and American countries such as the United StatesFDA and European EMA are still widely used in clinical practice, especially in patients with organ transplantation and immunosuppression, and have an irreplaceable antiviral status. Therefore, the reasons for its supply suspension are more related to domestic drug procurement policies, lagging generic drug declarations, market strategy adjustments of importing companies, or cost issues. Especially in the context of China's implementation of the volume-based procurement policy, some imported original drugs have chosen to voluntarily withdraw from the market because they cannot meet price requirements, causing patients to mistakenly believe that the drugs are "banned."

Although valganciclovir has side effects such as bone marrow suppression and nephrotoxicity and needs to be used under strict monitoring, its therapeutic benefits still far outweigh the potential risks, and the adverse reactions are controllable under the management of an experienced clinical team. Therefore, the suspension of supply cannot simply be attributed to "toxic drugs" or "national ban". At present, some domestic generic versions such as ganciclovir injection or tablets have been used instead in the market, but oral valganciclovir tablets still have advantages in terms of clinical convenience and bioavailability.

Reference materials:https://go.drugbank.com/drugs/DB01610