China's State Council has officially amended rules for vaccine distribution by banning wholesalers from direct sales to clinics at the provincial level where purchases will be centralized.
The State Council--China's cabinet--passed the changes this past weekend to cap its regulatory response to a ring, led by a mother and daughter team in Shandong province, which bought vaccines directly from makers over 5 years and sold them to clinics across several provinces--without following good distribution practices.
In a statement, the State Council said centers for disease control and prevention at the provincial level will centralize the purchase of type 2 vaccines--those bought voluntarily out-of-pocket--and at the county levels purchase directly from manufacturers.
Authorities had earlier said they wanted to institute a track-and-trace system to help eliminate third-party resellers.
"The center for disease control and prevention, inoculation unit, vaccine manufacturing enterprises and enterprises that are authorized for the distribution of vaccines are required to abide by the rules on the storage and transportation of vaccines, ensuring the vaccines being kept at the required temperature during the whole process, and regularly monitor the temperatures," the State Council statement said.
The Category 2 vaccines cover disease areas outside of national inoculation programs under Category 1 and come as private firms in China are ramping up new offerings, including recent domestic nods for hand, foot and mouth disease and a World Health Organization pre-qualification approval for Japanese encephalitis.
The incident caused embarrassment to Chinese regulators who have made safety and quality in manufacturing and distribution a hallmark of drug reform efforts.
Public anger surfaced after the illegal sales were reported of vaccines for meningitis, rabies and other voluntary jabs worth an estimated US$88 million.
In response, China arrested 202 people in the supply chain; 192 criminal cases were filed and 357 regulatory officials were punished at the China FDA, National Health and Family Planning Commission, and local authorities in Shandong and 16 other provinces, who were either fired or demoted.
- here's the State Council statement