A draft judicial interpretation spells out the circumstances in which life sentences or the death penalty can be meted out to producers or sellers of fake drugs who cause "very serious damage" to public health.

If fake drugs cause serious deformities or bodily harm to more than three people, or slight injury to more than 10 people, producers or sellers may have to be subject to such penalties, according to a draft rule made public by the State Food and Drug Administration (SFDA) on Wednesday for public comment.

The move comes amid intensified efforts to strengthen drug safety.

The Criminal Law stipulates that producers and sellers of fake drugs could face life imprisonment or capital punishment if their drugs cause "very serious damage" to public health or death, but it fails to define what the "very serious" damage is, posing difficulties for courts handling such cases.

The draft, jointly written by the Supreme People's Court and the Supreme People's Procuratorate, also stipulates that those who produce and sell substandard drugs that cause death, deformities or injuries may face life imprisonment.

It says if such cases happen during natural disasters or public health emergencies, violators will receive relatively heavier sentences within the scope of the law.

Hospitals that purchase, store or use drugs they know to be fake or substandard will face criminal charges as well, according to the draft.

If passed, the interpretation will be the country's first detailed guidelines on how to handle criminal cases of producing or selling fake drugs, but there is no timetable for its adoption, according to the administration's policy and legislation department.

SFDA officials reached yesterday did not want to comment on the draft interpretation, saying there may be changes before it is adopted.

The government has come under great pressure to overhaul the food and drug safety system after a series of controversies caused by shoddy products and corruption scandals involving high-ranking SFDA officials.

Zheng Xiaoyu, former SFDA director, was executed in July for corruption and dereliction of duty.

One of the most notorious cases of bogus drugs was that of Qiqihar No 2 Pharmaceutical Co Ltd, a privately-owned business in Heilongjiang Province, whose fake Armillarisin A injections killed 13 people.

(China Daily November 30, 2007)