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NIH makes wary return to India

Some clinical trials funded by US agency resume, but strict regulations have put off others.

A woman is treated in a Mumbai cancer trial. Credit: PSG/Eyevine
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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, 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.

The whole thing has had a very chilling effect for clinical trials and foreign sponsors.

Mazumdar-Shaw says that Biocon has already moved some of its trials to other countries, including ones that are far more expensive to operate in than India. She is particularly concerned about a requirement imposed by the Supreme Court in October to make a videotape of each trial participant giving informed consent — for a vaccine trial, that could mean video­taping thousands of patients. Meanwhile, several other companies have closed their Indian branches. In October the clinical trials contractor Quintiles, based in Durham, North Carolina, closed its phase I unit in Hyderabad, and on 31 January AstraZeneca, headquartered in London, announced plans to shut its Bangalore centre, although both companies maintain other facilities in India and say that the closures are due to restructuring. “The whole thing has had a very chilling effect for clinical trials and foreign sponsors,” says Amita Gupta, a researcher on ACTG trials at Johns Hopkins University in Baltimore, Maryland. “The motivation is coming from the right place, but the government overstepped.”

The health ministry that oversees the DCGI recognized this overstep and asked for recommended changes from a six-member panel led by Ranjit Roy Chaudhury, a pharmacologist and a former board member of the Medical Council of India. The panel’s July report gave various fixes, among which was a recommendation to scrap compensation for participants who received a placebo.

They also specified a new formula to calculate how much a participant who was harmed by a trial should be paid and suggested the formation of a national board to approve institutions’ ethics committees, which are responsible for determining whether an injury resulted from a trial and making sure informed consent was properly given. “We don’t want a single case of unethical practice”, says Y. K. Gupta, a pharmacologist at the All India Institute of Medical Sciences in New Delhi, who is helping to put together the board.

The DCGI has promised to implement most of the panel’s suggestions and has presented them to Parliament, which would need to codify the reforms. Already, some changes seem to be occurring; on 24 January, the agency announced that it would approve new clinical trials within six months of their submission. In addition, it clarified that an indemnity insurance requirement — insurance that would have been illegal for the NIH to buy under US law — can instead be purchased by partner institutions within India. Now that the rules are being clarified, Chaudhury hopes that researchers will reconsider their decision to suspend trials.

Yet, until researchers see laws in place, many will remain wary, says Amita Gupta. “I think a lot of groups don’t want to deal with the headache.”


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Reardon, S. NIH makes wary return to India. Nature 506, 143–144 (2014).

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