Chinese drug regulators step up nationwide inspections after latest vaccine scandal

China’s drug regulator has expanded its nationwide investigation of vaccine producers in the wake of the latest scandal, state media reported on Thursday.

The announcement by the State Drug Administration (SDA) late Wednesday came as the central government dispatched a team of investigators to investigate the country’s second largest rabies vaccine producer Changchun Changsheng, which is at the centre of China’s worst vaccine scandal in years.

The previous day the government also promised to establish a long-term mechanism to ensure vaccine safety.

The SDA said teams would be dispatched to investigate thoroughly the entire production chain of all Chinese vaccine producers, Xinhua reported.

The regulator said the countrywide investigation followed an earlier examination of 45 vaccine producers that started at the beginning of the year.

SDA said earlier this week that it would conduct unannounced inspections of vaccine makers’ production lines.

But the latest announcement said raw materials, the production process, quality checks and distribution would also be investigated.

Chinese officials who rise from the ashes of public crises

Chinese President Xi Jinping ordered a thorough investigation into Changchun Changsheng Bio-technology, which is based in Jilin province, on Monday, saying the violations were “serious and appalling”.

The company was ordered to halt production after an unannounced inspection this month found it had forged production data for rabies vaccines.

A sample check last November also found Changsheng and Wuhan Institute of Biological Products had produced inferior DPT (diphtheria, whooping cough and tetanus) vaccines which had been administered to more than 401,000 children as young as three months old in Chongqing, Hebei and Shandong provinces.

Changchun police have detained 15 executives and staff from the drug maker, including its chairwoman Gao Junfang.

The Changchun inspection team, headed by Bi Jingquan, deputy director of the State Market Regulator which oversees drug safety, pledged to severely punish offenders and “safeguard the bottom line of safety to ensure social stability”, the state news agency Xinhua reported.

Public servants will also be investigated to find out whether there has been any dereliction of duty and those found to be held responsible will be punished.

The team will also study measures to reform and improve vaccine regulation and set up a long-term mechanism to protect vaccine safety.

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“Regulatory oversight of vaccines is critically important. It is the government’s primary method of ensuring that the vaccines produced and used in China are safe, of good quality and effective,” said Gauden Galea, World Health Organisation Representative for China in a statement.

It is unclear who else is part of the investigation team, but other government and Communist Party agencies, including the National Supervisory Commission, the Ministry of Public Security, National Health Commission and China Securities Regulatory Commission, will report to the team, according to the Xinhua report.