China’s Cold Chain Scrutinised following Multimillion-Dollar Illegal Vaccine Investigation
China’s State Council has passed an amendment on vaccine regulations just weeks after the launch of an investigation into incorrectly handled vaccines took place, in ‘a case that shook the country’.
The amendment, which impacts multiple articles within Regulations for the Circulation and Inoculation of Vaccines, was passed on April 24th.
Cold chain storage and transportation are both a prime focus in the updates, with the Center for disease control and prevention, inoculation units and vaccine manufacturing enterprises being required to safeguard vaccine temperature throughout the process and monitor the levels frequently. Comprehensive sales records depicting the purchase, storage, distribution and supply of vaccines must be formulated by the vaccine production enterprise. This record should remain on file for up to two years after the vaccines expire. Inoculation units should request a temperature monitoring record so a purchasing and reception record can be created.
Centers for disease control and prevention are expected to report to a country drug watchdog with integrity in regards to vaccines that have unidentified labelling, breached expiry dates, flouted from the cold chain, did not meet a certain requirement or have an unidentified source. The destruction of these vaccines needs to be supervised by authorities; a record of their termination needs to be stored for a minimum of five years.
This legislation change comes after reports of improperly stored and dated vaccines caused concerns to flare in China.
Shandong police revealed earlier this year that arrests had been made on the grounds of the suspected illegal sale of unfit vaccines equating to more than 570 million Yuan (approx. €76 million). The case at hand is suspected to have impacted 20 provincial areas since 2011. Police in the east of the Shandong province are understood to have detained 37 suspects in connection with the case and three pharmaceutical companies are being examined.
A representative of the CDFA noted that this case exposed problems in the distribution of vaccines. The body has been collaborating with law enforcement bodies in the investigation of the situation and pinpoint and address loopholes.
In a statement, Premier Li Keqiang said that these concerning reports placed a spotlight on weaknesses in the supervision system. He added that enhanced coordination needed to occur between the China Food and Drug Administration (CDFA), National Health and Family Planning Commission, and Ministry of Public Security so that they can better ‘[respond to] public concern in time, severely punish illegal behaviour and hold related officials accountable.’
China’s cold chain has been dubbed as ‘one of the hottest sub-industries of logistics’, with temperature controlled logistics set to develop as an attractive area of interest for investors. (3)
Although, there is work to be done in this region. China’s surging demand for fresh food is shifting more responsibility onto the cold chain, with tonnes of fresh produce currently going to waste due to the lack of airtight temperature controlled transportation in some cases. Added to this, transportation technology used within China’s cold chain has been labelled as relatively outdated. The expanding third party cold chain transportation industry and its strengthening management efficiency and style has been noted as a key solutions to nurture China’s cold chain logistics.
The short-comings of China’s existing cold chain infrastructure are becoming increasingly apparent as it struggles to meet demand. Whilst tier 1 cities like Shanghai and Beijing are hubs for China’s cold chain, the rest of China’s cold chain system is highly disjointed.
Rabobank recently stated that China’s cold chain structure will require around US$85 billion of investment over the next ten years to address issues such as quality and volume.(1)
However, one evaluation made by Cleanleap.com, is that traditionally investment seems to be patchwork in culture, with more resources dedicated to cold storage in comparison to refrigerated transport. (2)
This is combined with a lack of comphrehensive internationally recognised best practices in cold chain operations, meaning that reliably transporting temperature sensitive products across the rest of the country is extremely challenging and costly.