China plans a root-and-branch overhaul of its vaccine management system focused on out-of-pocket voluntary inoculations that will ban direct purchases from manufacturers for provincial and county-level clinics.
The move seeks to enable a track and trace process from purchase to distribution to the clinic, according to a notice from the State Council.
"An information management system regarding vaccine inoculation will be established in order to trace the whole process from production to circulation," the State Council, China's cabinet, said. "Cold chain storage management and transportation will also be enhanced."
The statement was in response to public anger after authorities found an illegal vaccine sales ring led by a mother and daughter team in Shandong province that bought vaccines directly from makers over 5 years and sold them to clinics without following good distribution practices.
The value of the vaccines for meningitis, rabies and other voluntary jabs reached $88 million, according to reports.
That led to the arrests of 202 people in the supply chain, 192 criminal cases filed, and 357 regulatory officials punished in the China FDA, National Health and Family Planning Commission, and local authorities in Shandong and 16 other provinces who were either fired or demoted, the State Council said.
The so-called 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.
But as important is the embarrassment caused to Chinese regulators who have made safety and quality in manufacturing and distribution a hallmark of drug reform efforts.
- here's the State Council statement