Lack of export control may give room for exploitation

When Indian pharmaceutical company Kayem dispatched stocks of sodium thiopental to the U.S. early this year, they thought it was a golden chance to bring in good business and build a reputation. What came, instead, was, in the company's words, “a bouncer.”

Little did Kayem know that the drug they so eagerly parcelled off to the U.S. was being injected into prisoners on death row for their execution in the prisons of Nebraska and South Dakota.

“We thought exporting to the U.S. will be good for us. We sold 500 vials of the drug to Nebraska and 500 to South Dakota, not knowing its end use. When we learnt it was being used for execution in U.S. prisons it was a total bouncer. We issued a public statement announcing that we have discontinued selling it to them,” Navneet Verma, managing director of Kayem told The Hindu on the phone on Monday.

The truth about the use of sodium thiopental for non-medicinal purposes was uncovered by Maya Foa, investigator from a U.K. legal NGO ‘Reprieve'.

“The medicine is being used in large parts of the world for medicinal purposes, but in the U.S. it is being diverted for executions,” Ms. Foa told a press conference recently in the city. This “misuse” of the drug, its shortage in the U.S. and attempts by the country to obtain the drug from various European nations has given rise to a body of controversy that soon threatens to engulf the Indian pharmaceutical industry, Ms. Foa pointed out.

But India seems to be unawares of the repercussions of selling to the U.S. Lack of export controls provides an easy leeway to the U.S. to purchase from unsuspecting manufacturers like Kayem.

“Domestic shortages of execution drugs mean the U.S. is now seeking supplies abroad. Sodium thiopental is not used for medicinal purposes in the U.S. and the last remaining manufacturer pulled out of the market in January…Right now India is the source destination for the U.S.,” Ms. Foa said.

Representatives from Reprieve who met Indian officials said the authorities washed their hands of the issue. “They said the drug was not a controlled substance. It's a strange situation where the FDA [Food and Drug Administration] says they will not check the drugs,” advocate Vijay Hiremath from Centre for Access to Rights said.

Despite several attempts, the Drugs Controller General (India) was not available for comment. However, an FDA official from Maharashtra, who did not wish to be quoted, told The Hindu on the phone: “There is no export control on the drug. Companies are allowed to manufacture and sell. The drug is manufactured to be used in providing anaesthesia. If someone is abusing it, that's illegal. The FDA only checks drug quality. India cannot do anything about what happens [in the US] when the drug is exported.”

That has not been the case in Europe though. After Hospira, the sole U.S. manufacturer of sodium thiopental stopped production, the country turned to the U.K., Germany, Italy and Denmark.

In all these attempts, European companies were either dragged into lengthy and expensive litigations in the U.S. from defence lawyers or the U.S. authorities seized the drugs when they were found to be “illegally imported”.

The European Commission has drafted an amendment to a European regulation which will make it illegal to sell sodium thiopental and other potential execution drugs to the U.S. without a licence. In 2010, the U.K. government put an export control ending the business of Dream Pharma, a British wholesale company providing the drug to the U.S., Ms. Foa said.

In addition to seizure of European drugs, “the U.S. Drug Enforcement Agency (DEA) ordered the seizure and destruction of drugs imported from India to Nebraska and South Dakota”.

The U.S. made its second attempt to tap an Indian manufacturer ‘Ganpati Exim'. Its third attempt was to turn to Naari, a Swiss company manufacturing the drug in India.

A U.S. dealer obtained the drug from Naari under the pretext of supplying it to Africa, where it is sorely needed. However, once the company learnt of the end use, it cancelled all orders.

Ms. Foa, who met officials in Mumbai and New Delhi, said there was a “need for the pharma industry and Indian authorities to come forward and say no to the execution drug”.

Export of the drug does not even make good business sense. The drug is cheap and it takes only 5 gm per execution. “The entire market is worth not more than 7,000 rupees or $130 per annum,” Ms. Foa said. “If the U. S. does not get the drug and India puts up a fight, it will change the landscape,” she said.

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