Regulation failing to keep up with India's trials boom

Original article by: A Yee

Reference: Lancet 4 Feb 2012;379(9814):397-398

Source: Lancet

Keywords: Clinical Trials; Doctors-Hospital; Drug Industry; Ethics Committees; India; Informed Consent; Patient Safety;

Date published: 03/02/2012 08:46

Summary
by: Pharm-line

There has been a dramatic increase in clinical trials being conducted in India, with 1852 trials registered on the government website Clinical Trial Registry India (CTRI) at Jun 2011, compared with only 40 to 50 being conducted in 2003.  The lower costs and relatively good research infrastructure have encouraged international pharmaceutical companies and contract research organisations to base trials in the country.  However, there have been serious concerns over ethical violations and a shortage of experienced personnel.

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