Ruling on execution drugs will have echo in India
NARAYAN LAKSHMAN
March 28, 2012
In a landmark ruling, a U.S. judge has ordered the Food and Drug Administration regulator to immediately notify state correctional departments across the country that the use of foreign-manufactured sodium thiopental, a drug used in executions, is prohibited by law and that, any vials of the drug that they possessed must be returned at once to the FDA.
The judgment, issued by U.S. District Judge Richard Leon, may mark a worrying inflection point for U.S. prisons, many of whose supplies of the unconsciousness-inducing thiopental have dwindled dramatically after its sole U.S. manufacturer, a firm called Hospira, voluntarily shut down operations in 2010 bowing to the negative publicity associated with the lethal use of the drug.
In what appeared to be desperate attempts to bolster stocks of thiopental a slew of these correctional facilities went on to seek out alternative suppliers of the drug or switch to pentobarbital, a veterinary euthanasia barbiturate used to put down dogs. This week's judgment will also echo in India, where some firms were tapped as potential suppliers of the drug.
After attempts to source the drug from a firm in the United Kingdom met with a storm of opposition across Europe and led to the ban of all such drug exports to the U.S. in that continent, a Mumbai-based firm called Kayem Pharmaceuticals was contacted by an intermediary acting on behalf of the Nebraska Department of Correctional Services.
When a U.K.-based anti-death penalty group called Reprieve highlighted the fact that despite not being approved by U.S. regulators Kayem had handed over 500 one-gram vials of thiopental — enough to kill 166 men – to the middleman, named Chris Harris, and then it had passed on to the NDCS, the intense pressure on Kayem led to it stating publicly that it would immediately halt all exports of thiopental to the U.S..
Though the U.S. Drug Enforcement Agency warned the NDCS and others that proper importation procedures had not been followed for the Kayem drugs, Harris succeeded in obtaining even more supplies of thiopental from a Swiss-Indian pharmaceutical company called Naari, this time under false pretences.
Naari's CEO Prithi Kochhar arguing that he had given Harris 485 grams of sodium thiopental for the sole purpose of legitimate drug testing in Zambia, and that he was “shocked and appalled” by the prospect that the drugs could be used in U.S. executions, the NDCS was poised to use the Naari drugs on one death row inmate, Michael Ryan, earlier this month.
Ryan's attorney had filed several legal challenges to the use of untested thiopental that was also not certified for import by the FDA. Those challenges are likely to receive a boost from this week's ruling, which also argued that FDA could no longer permit the entry of foreign manufactured thiopental into interstate commerce.
http://www.thehindu.com/news/international/article3255056.ece