China bans wholesalers from selling vaccines following scandal

China banned drug wholesalers from selling vaccines and demanded more accountability following a scandal in which millions of dollars' worth of improperly stored vaccines were sold to patients nationwide, according to a decision published recently.

Premier Li Keqiang signed a decree on April 23 to release the decision, a draft of which was endorsed at an executive meeting of the State Council, China's cabinet, on April 13.

The decision to amend a regulation on managing vaccine circulation and use reformed distribution channels for the country's B-class, or non-compulsory, vaccines.

It requires B-class vaccines to be distributed in the same way as A-class ones, which are covered by the national compulsory immunization program.X B-class vaccines must be procured by county-level disease control institutions directly from manufacturers and dispatched to hospitals, all under the organization of provincial-level disease control organs, according to the decision.

Virtually all vaccine circulation will occur under official arrangements.

The decision also requires disease control organs, hospitals and clinics to keep clear records of their purchases and received inventory.

The decision also improves management of cold-chain storage and transportation, prohibiting vaccines from leaving the cold-chain system and requiring regular temperature monitoring.

Institutions or hospitals must request storage temperature records upon receiving vaccines, said the decision.

China will set up a vaccine tracking system, according to the decision, saying enterprises and user agencies must record information about the circulation and use of vaccines so that even the smallest vaccine package can be pinpointed anywhere in its entire life cycle.

All agencies handling vaccines must report vaccines without a clear source or recognizable packaging to drug authorities. These vaccines will be destroyed under the joint watch of drug and health authorities.

The decision also heightened accountability. Fines for serious violators, such as those improperly storing and transporting vaccines, will be increased. Government officials will be required to resign from their jobs if they fail to perform their supervision duties well.

The decision took effect on April 23. Endi