The State Drug Administration (SDA) will revise the existing laws and regulations and map out new ones to adapt to demands from consumers and aid the country's entry to the World Trade Organization, sources with the SDA said.

The crackdown on making and marketing fake and substandard medicines will go on and over the next three years. The SDA will set up a national information network for the supervision and management of pharmaceuticals and medical devices.

According to the SDA, China currently has only one law and 10 State Council regulations for the management of the industry and distribution in the country. Some of them will be revised in line with current economic and social conditions.

Data from the SDA indicates that the country has witnessed a large increase in the pharmaceutical and medicine distribution network over the past two decades. Industrial output value grew by 17.6 percent a year between 1978-99.

One of the largest pharmaceutical producers in the world, China has registered more than 6,700 pharmaceutical plants and 6,000 factories which produce medical equipment. The factories had produced 1,400 kinds of chemicals, 4,000 types of compound medicines and 8,000 traditional Chinese medicines by the end of 1999.

There are more than 16,700 pharmaceutical wholesalers across the country, as well as more than 120,000 retail drug stores.

The central government tightened its quality control over medicines in the early 1990s to safeguard public health.

Last year there were up to 50,000 cases of fake or substandard medicines produced and marketed, and seven people were jailed for illegal practices in the sector.

Drug administrative departments nationwide closed 1,345 factories.

The present State Law on Pharmaceutical Management was adopted in 1984 and took effect a year later.

The new amendment to the law has passed its second reading at the National People's Congress and is expected to be put in force after a third reading later this year.

The revised law will emphasize that punishments will be carried out where people are involved in producing counterfeit or inferior medicines.

The SDA will also draft two new laws on the licensing of pharmacists and management of medical equipment. The two drafts will be submitted to the National People's Congress for amendment and approval within the next five years.

In addition to the three laws, the SDA plans to submit seven regulations for approval that include regulations on classified management of prescribed and over-the-counter medicines, management of radioactive treatments and the protection of traditional Chinese medicines.

(China Daily 01/20/2001)