Mark A DeSorbo
BEIJINGAction has been swift in China's crackdown on substandard pharmaceutical manufacturers and shoddy, used medical equipment sales, but it would seem its State Drug Administration (SDA) is just getting warmed up.
The latest developments in a crackdown launched by SDA just over a year ago is the revision of the Drug Management Law and heightened supervision of drug makers under the International Good Manufacturing Practice (GMP) system, which China adopted in 1980, according to SDA officials.
Bai Huiliang, the SDA's chief of security supervision office, told the Economic Information Daily newspaper in China that this year he expects that several of the country's 6,300 pharmaceutical firms will be closed, merged or ordered to halt production. He added that domestic market supply would not be affected.
Industry professionals in the United States agree that while enforcement is key for any regulation, GMP is also necessary for global industry viability.
“It's not the aspect of instituting a regulation. It's enforcing it,” says pharmaceutical and biotechnology consultant James Agalloco, president of Agalloco & Associates (Belle Mead, NJ). “That makes all the difference. If you read Italy's GMP regulations, they seem very rigid, but there is no real reinforcement there.”
Hank Rahe, a member of the CleanRooms Editorial Advisory Board and director of technology at Contain-Tech (Indianapolis), agrees, saying that China is making an effort to become an exporting nation. “To do that, they have to meet the world standard and that world standard is the GMP system,” he adds.
The global GMP system is often a large agenda item for the International Conference on Harmonisation (ICH), which is comprised of three regions having representatives from Japan, Europe and the United States.
Although China has attended some ICH sessions, the country is not a voting member, nor could it be because of the way the ICH is set up, says Joseph Phillips, a member of the ICH subgroup on active pharmaceutical ingredients and a deputy regional food and drug director for the FDA in Philadelphia.
The key to ICH efforts, Phillips says, is GMP guidance. “It not a law or regulation, it's an expectation,” he adds.
China is raising expectations to ensure the safety of citizens, about 2.5 million of whom go to the hospital annually because of a bad reaction to self-medication.
According the SDA, the GMP system will be phased in throughout different categories of pharmaceutical makers during a restricted period. Manufacturers failing to meet the GMP standard will be ordered to halt production. Of 38 blood-product manufacturers in China, 34 had GMP certification. The four firms that did not receive GMP certification have been ordered to halt production.
Powder-injection and large-capacity injection drug producers were required to meet the GMP standard by the end of 2000, while small-capacity injection drug makers must comply by the end of 2002.
More than 500 companies (including workshops) should have GMP certification by the end of this year. According to SDA restrictions, GMP-certified firms are eligible to accept manufacturing processing orders from other cities. Firms without GMP certification, however, will have their production halted, but can reapply for a certification during the restricted period. These firms are also eligible to entrust certified companies to manufacture pharmaceuticals for them. Newly established pharmaceutical factories must obtain a GMP certificate prior to applying for an operation license.