A New Colonialism? — Conducting Clinical Trials in India
- 21 April 2005
- journal article
- editorial
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 352 (16) , 1633-1636
- https://doi.org/10.1056/nejmp048361
Abstract
In January 2005, the government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries. This new rule supersedes a directive of India's Drugs and Cosmetics Rules that required a “phase lag” between India and the rest of the world. According to the old rule, if a phase 3 study had been completed elsewhere, only a phase 2 study was permitted in India. Even under the new rule, phase 1 trials . . .Keywords
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