8-28-2012 But an examination by Reuters has found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.
Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China’s State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.
“There is falsification of APIs going on, we know it,” said Lembit Rago, coordinator for Quality Assurance and Safety in Medicines with the World Health Organisation (WHO)….
“Any number of foreign pharmaceutical companies go no further than looking for API suppliers at CPhI (an international pharmaceutical fair) based only on price,” Walsh said….
About 70 to 80 percent of all active drug ingredients — the biologically active component in medicines — originate in China and India, estimate industry experts, with China accounting for the lion’s share. Its export market in these products is worth $22 billion in annual sales, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.
“If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty,” said Villax….
“There are a lot of brokers who are relabeling (APIs) which means you can’t trace where the API comes from and that adds to the risk,” said the WHO’s quality assurance expert Rago.
Andre, the Belgian drug detective, estimates he has uncovered fraud or misrepresentations in as many as 25 percent of cases where he has been hired to audit factories all over China. “If you can substitute an API that is expensive to make and manufactured at a high level with something that costs much less, then that can happen,” Andre said. “It’s impossible to give an exact number, but it’s not rare. It’s a minority, but not tiny minority.”
The human cost can be high. Low-quality and fake anti-malarial drugs accounted for more than a third of samples recently analyzed in sub-Saharan Africa, according to a study in the Lancet Infectious Diseases journal in May. Separate research in the journal Research and Reports in Tropical Medicine found Chinese-made drugs to treat malaria and other common tropical infections performed particularly poorly in tests.
“I think Chinese exporters to Africa know that bad products will be less likely spotted there,” said Roger Bate, resident scholar at the American Enterprise Institute, who led the second study. http://vitals.nbcnews.com/_news/2012/08/28/13529298-drug-ingredients-made-in-china-entering-market-with-little-oversight?lite
the new synthetic drug trade, a globalized marketplace in which Chinese chemical companies pump out large volumes of ever-changing substances that are too new to be banned internationally, leaving law enforcement officials in America and elsewhere struggling to slow the influx of the drugs (or their primary chemical components).
They’re also coping with the considerable fallout of this new flood of dangerous chemicals; in Florida, for instance, the highly addictive synthetic drug “flakka” is now wreaking havoc in some parts of the state — including giant Broward County, where one major hospital system has reported seeing up to 20 flakka-related emergencies in one day, and where at least 16 deaths have been attributed to the cheap drug since September…
A kilogram of alpha-PVP — the main ingredient in flakka — can be purchased for $1,500 online and sold for $50,000 on American streets, Hall said. Recently, he noted, authorities have intercepted shipments more than 10 times that size.
Complicating the fight against flakka, authorities say, is the fact that the drug is not illegal in China, where labs employ “classically trained chemists” and categorize the drug as a “research chemical,” according to the DEA.
Authorities at the state and federal level said the exact number of labs and chemists producing synthetic substances like flakka — known internationally among health experts and law enforcement as a New Psychoactive Substance (NPS) — is unknown. On the Chinese chemical supplier Web site, guidechem.com, the New York Times found more than 150 Chinese companies selling flakka.