A new colonialism?: conducting clinical trials in India

Nundy, S; Chir, M and Gulhati, Chandra M (2005) A new colonialism?: conducting clinical trials in India. The New England Journal of Medicine, 352:1633-1636 (16). ISSN 1533-4406

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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 will not normally be permitted in India. The old rule was designed to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin; trials of domestically discovered drugs were not subject to this provision.

EPrint Type:Article
Uncontrolled Keywords:Drugs Controller General of India, Clinical Trials, FDA, Drug Trials, Ethics, India, Clinics
Subjects:Investigative Techniques > Models, Animal
Therapeutics > Clinical Protocols
Animals > Chordata > Vertebrates > Mammals > Rodentia > Guinea Pigs
Pharmaceutical Preparations > Drugs, Investigational
-Institutional Repositories > Sir Ganga Ram Hospital, New Delhi
ID Code:212
Deposited By:Mrs Naina Pandita
Deposited On:05 July 2005

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