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"Mend the Fold after the Sheep are Lost"----China Tightens Control over Drug Safety

“It’s never too late to mend the fold after the sheep are lost….”

This time-honoured Chinese proverb may epitomize the significance of a string of events that happened in July in connection with drug safety in China.

These events came in swift succession. On July 10, Zheng Xiaoyu, former chief of the State Food and Drug Administration (SFDA) of China, the national watchdog for drug and food safety, was executed for taking bribes and dereliction of duty. At a press conference held the same day, the State Council, China’s highest governing body, made public the State Plan for Food and Drug Safety during the Eleventh Five-Year Plan (2006—2010). On the following day, the SFDA published a set of revised rules to tighten control over drug safety. In reporting the publication of the revised Provisions for Drug Registration, the Xinhua Daily Telegraph used a banner headline reading “Overhaul the Drug Safety Control System by Constraining Official Powers and Strengthening Oversight.”

The Xinhua Daily Telegraph is a daily newspaper run by Xinhua, China’s State news agency.

"Killing Three Birds with One Stone"

Zheng, 63, was sentenced to death on May 29 by the First Intermediary People’s Court of Beijing. He was accused of taking 6.49 million yuan (US$850,000) in bribes from eight pharmaceutical companies in return for approving the marketing of certain fake or substandard medicines, including one antibiotic that killed a dozen people. Zheng appealed to the Higher People’s Court of Beijing, which upheld the sentencing after the second hearing of the case on June 22. Barely two weeks had passed before the Supreme People’s Court ordered his execution after a re-examination of the case.

The People's Daily, the chief organ of the ruling Communist Party, said in its report on Zheng's execution: “Corrupt elements will be prosecuted in accordance with the law no matter who they are, what official posts they hold, and how deep they hide, and there can be no appeasement or softness.”

But Zheng was not the only SFDA official brought to justice for corruption. Four days before Zheng’s execution, on July 6, Cao Wenzhuang, former head of the SFDA Drug Registration Department, was sentenced to death with execution suspended for two years for taking bribes. Earlier, in November 2006, Hao Heping, former director of the SFDA Department of Medical Apparatus, was sentenced to 15 years in jail for the same crime. Both Cao and Hao had been Zheng’s secretaries before they were promoted to head the two most important subdivisions of the SFDA. It is no secret in China that secretaries are often the most trusted lieutenants of their bosses.

The SFDA lost no time to “mend the fold.” Shortly after Zheng was arrested near the end of 2006, leading officials at this sub-ministerial agency were ordered to attend a one-month “study session,” during which those who had committed wrongdoings were given a last chance to confess. All were bound to attend, including those who had retired. No wonder. Even in retirement, Zheng continued taking bribes.

In a related development, the SFDA Drug Registration Department was reorganized, reportedly with virtually all staff members sacked. “Fold-mending,” so to speak, culminated in the publication of the revised Provisions for Drug Registration, replacing the “old” or the original Provisions put into effect on May 1, 2005. Observers are keen to note that the revision is meant to “kill three birds with one stone”: to tighten drug safety control, to encourage development of new and “innovative” drugs and at the same time, to curb corruption within the SFDA establishment.

Under the revised Provisions, the “threshold” is raised for the registration and approval of drugs. From now on, certificates of approval will be issued only to drugs verified as new or “innovative.” Pharmaceutical companies may apply for registration of old drugs in new forms, but on no account will such drugs be labelled as “new.”

The SFDA reportedly used to approve more than 10,000 “new” drugs a year—indeed an astronomical figure in contrast to a few dozen approved by the US Food and Drug Administration (FDA) a year. A vast majority of the “new” drugs approved by the SFDA—if not all—were old drugs in new forms. Here is the trick: under Chinese laws, the producer of a new drug is given the privilege of fixing selling prices for the drug on its own, prompting numerous pharmaceutical companies to bribe officials like Zheng so that their old drugs in new forms—for example, pills based on the same liquid drugs used for injections— could be priced as “new” drugs.

Under the revised Provisions, on-the-spot checks are required in all processes for the development and production of new drugs, ranging from the testing of the raw materials, the non-clinical and clinical trial use of the drugs through to their production, with samples to be supplied at any time, on demand. Checkups will continue after a new drug is put on sale, to ensure that the product available on the market is exactly the same thing that has won SFDA approval. Wu Zhen, a deputy director of the SFDA, admitted that only “minimum” checkups were conducted in the past. “Application documents were often inadequate, and from time to time companies used forged documents to get their products registered,” Xinhua quoted the official as saying. “Under the revised Provisions, those who use forged documents will be fined and deprived of the right to apply. We will also publish a blacklist of those involved in the worst cases.”

Wu said that fairness and openness is a guiding principle of the revised Provisions. In the past, she said, the time limit was 20 days for an examination and approval of any drugs. Under the revised Provisions, however, the time limit may be shortened for new and “innovative” drugs provided the procedures are strictly followed.

Before examination of the application for registration of a new drug, Wu said, the SFDA will make the names of the members of the examination panel public. “Those with connections of interest with the applicant will have to withdraw.”

To strengthen public oversight, the SFDA has institutionalized a monthly press conference. The first press conference was held on July 11, the day after its former chief, Zheng, was executed, to announce the publication of the revised Provisions.

National Plan for Food and Drug Safety

The duties and responsibilities of the SFDA and local food and drug agencies are defined, for the first time, in the revised Provisions. Also defined are rules for investigation into dereliction of duty. One guiding principle, Wu Zhen said, is to constrain the official powers for drug examination and approval, so that no one in the establishment can be free from supervision. “In the past,” the official said, “whatever Zheng Xiaoyu said was law.”

The revised Provisions will become effective for implementation on October 1, 2007. Despite that, the People’s Daily reported, “The government has, since last year, been intensifying inspections to weed out fake and substandard drugs.” Many thousands of drugs with licenses due to expire this year now have to be re-licensed.

Shao Mingli, the current SFDA director, in an interview with the People’s Daily on July 8, said, “We will not let fraudulently obtained licenses get re-registered.”

In 2007, the SFDA has shut down five drug manufacturers, including the Qiqihar No. 2 Pharmaceutical Company, the producer of a fake injection known as “armillarisni” that killed 11 people. The product, used for treating inflammation of the gall bladder wall, allegedly contained diglycol instead of propylene glycol, which may cause kidney failure.

Another company, Guangdong Baiyi Pharmaceuticals, also had its license revoked for producing haemoglobin, a blood product, which was found infected with a virus. In addition, 128 drug makers have had their GMP (good manufacturing practice) certificates withdrawn in a nationwide campaign to clean up the pharmaceutical industry. Under both domestic and international rules, a GMP certificate is a must for a company to get a drug registered.

The SFDA will no longer bear sole responsibility for fighting against fake and substandard drugs and their makers. The State Plan for Food and Drug Safety during the Eleventh Five-Year Plan was formulated under the guidance of the National Development and Reform Commission, involving officials and experts from the ministries of health, agriculture, finance and science and technology, in addition to the SFDA and the State Industry and Commerce Administration. Vice-Premier Wu Yi finalized the food and drug plan, the very first of its kind in China.

“It indicates that for the first time, food and drug safety has been made a part of the national plan for economic and social development,” the People’s Daily opined.

The plan sets nine targets that must be met by 2010, including one that calls for developing a nationwide network of drug and medical apparatus inspection along with a medical emergency response system. By 2010, 100 percent of the drugs and medical apparatus in use will be subject to regular checkups by the government.

A "Pitched Battle"

The State Plan for Food and Drug Safety during the Eleventh Five-Year Plan describes food and drug safety as something that “not only concerns the safety of the people’s health and lives but also has an overall bearing on the country’s economic development.” Fulfilment of the plan is “a vital part of the national endeavour to build a harmonious society under socialism.”

Still, government officials admit that China is facing a host of challenges in making the plan work. “Ours is still a developing country, and it is relatively late for China to begin attaching sufficient importance to food and drug safety,” Yan Jiangying, a spokeswoman for the SFDA, told the press conference on July 10. “We have had a weak foundation for our work.”

SFDA chief Shao likened the overhaul of his agency and the fight against substandard food and drugs to a “pitched battle.”

“We must face the fact that there are still problems which cannot be ignored,” he said. “In some regions, work to get things right is done perfunctorily.”     

Meanwhile, publication of the new plan, along with the overhaul of the SFDA and the execution of the agency’s former chief, has been perceived at home and abroad as the strongest signal yet that China is moving to crack down on the production and sales of dangerous food and medicines, which comes as a part of the ruling Communist Party’s effort to build a cleaner government.

Zheng Xiaoyu’s case was handled directly by the Party’s Central Discipline Inspection Commission. He was the fourth ministerial or higher level official to have been executed for corruption in recent years. Among the other three was Cheng Kejie, a former vice-chairman of the Standing Committee of the National People’s Congress, who was executed in August 2000 for taking 41.09 million yuan (US$5.48 million) in bribes, either directly or through his mistress, a businesswoman named Li Ping.