China's complex API regs fuelling US meth problem says congressional committee
The US-China Economic and Security Review Commission set out its concerns in a report this week, claiming Chinese manufacturers supply 80% of the chemical precursors ephedrine and pseudoephedrine that are used to make meth sold in the US.
The authors said: “Chinese manufacturers of meth precursors have thrived because the country’s vast chemical and pharmaceutical industries are weakly regulated and poorly monitored” adding that China cannot “adequately” inspect and monitor its manufacturers.
The criticism – which fits with a recent US State Department report – follow a month after China’s Central Commission for Discipline Inspection (CCDI) questioned the China Food and Drug Administration’s (CFDA) ability to regulate drug and API production (here in Mandarin) due to a lack or resources.
According to official CFDA data, the organisation conducted 221 pharmaceutical manufacturing facility inspections in China 2015, down from 482 visits in 2014 and 584 in 2013.
While the inspections focused on manufacturing standards rather than the detection of illegal precursor production or diversion, the decline in the number of visits lends weight to the suggestion the agency lacks resources.
The CFDA has since announced a staff training and recruitment programme.
Complex regulations
A further complication – which was also highlighted by the US congressional committee – is that the CFDA does not regulate producers of non-pharmaceutical chemicals, which are also believed to be a significant source of crystal meth precursors.
Worse still was the introduction of rules in 2011 which, despite being designed to improve oversite of chemical manufacturers, saw some API and pharmaceutical chemical producers register as non-chemical suppliers to avoid inspection by the CFDA.
This loophole was closed in 2014 when the Chinese State Administration of Work Safety implemented regulations on the management of precursor chemicals that enforced stricter licensing requirements.
US role
The onus on preventing APIs and chemicals being diverted by criminals is with China according to US-China Economic and Security Review Commission, which said more effective enforcement and further efforts to address regulatory loopholes are needed.
The US, according to the authors, should work to strengthen regulations covering the shipment of chemicals in collaboration with international partners.
The also suggested the US should encourage the Chinese Government to make regulation of the pharmaceutical and chemical manufacturing sectors less complex.
“Giving one agency like the CFDA sole authority over pharmaceutical and chemical production in China would formalize inspection practices, allow for better distribution of counternarcotic resources.”
