Posted on February 12, 2014
Source: Nature
Allayed by pledges that India’s strict new rules for clinical trials will be eased, a few principal investigators funded by the US National Institutes of Health (NIH) are cautiously restarting studies there. Clarifications on the rules by the Drug Controller General of India (DCGI), and a promise to soften others, have allowed a small number of researchers to return to their work.
But for most others, the damage has already been done. Trial operators — both academic and industrial — have left India for other countries. Some researchers say that India’s clinical trials industry, which boomed over the past decade, may now be grinding to a halt.
“I don’t think we’re going to walk away from research in India, but it will certainly slow us down,” says Daniel Kuritzkes, a virologist at Harvard University in Cambridge, Massachusetts, and head of the international AIDS Clinical Trials Group (ACTG). Last March, after the new rules were announced, his group suspended two NIH-funded antiretroviral drug trials and a cervical cancer screening trial. The latter has resumed patient enrolment now that the DCGI has clarified that the rules apply only to drug trials. But the antiretroviral trials were completed elsewhere, and the group has been unable to enrol Indian patients in new trials for tuberculosis and HIV drugs. “Obviously we have to continue research with or without our Indian colleagues,” Kuritzkes says. “We would much rather do it with them.”
Researchers had flocked to India because trials are cheap to conduct and there are many people with disease who can be signed up. But a crackdown began in January last year, when India’s Supreme Court, concerned about allegations of unethical practices and deaths linked to trials (see go.nature.com/aa5xl2), imposed a ban on new ones. It told the DCGI to tighten its regulations, and the agency responded with a set of tough new rules to beef up patient protection.
In response, the NIH placed at least 35 ongoing clinical trials on hold. The law was vague and open to interpretation, researchers say: it seemed that trial sponsors would be required to provide medical care for trial participants for the rest of their lives, regardless of whether the trial itself had caused a medical problem. It also seemed that patients who received placebos, or for whom the drug did not work, would be entitled to compensation. “They went from one extreme to the other extreme,” says Kiran Mazumdar-Shaw, chief executive of Biocon, which is based in Bangalore and is one of India’s largest biotechnology companies.
