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Why NIH, companies now eschew India for clinical trials
Related tables, figures and sidebars
India's clinical trial vacuum
Monday, July 29, 2013
NIH's recent decision to suspend or delay clinical
studies in India is a consequence of a clumsy rule change hastily implemented
by the country's regulatory authority. Stakeholders in industry and the
clinical community in India agree on a solution proposed by an advisory
committee to the Drug
Controller General of India, but opinions vary as to whether it will be
months or years before the government sees fit to address the issue.
In January, India's Ministry
of Health and Family Welfare published new rules governing the conduct
of clinical trials in an effort to ensure patient safety after a rash of media
reports and subsequent litigation related to clinical trial deaths led the
country's Supreme Court to intervene by directing the ministry to make reforms.
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