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   India International Medical Equipment Expo - Delhi 1st Nov'2011
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Govt. registered Ethics Committee to include Housewife as a member :
On investigating the clinical trials of a breast cancer drug allegedly given to 30 illiterate agricultural labourers by the Hyderabad based Axis Clinicals, the Drugs Controller General of India (DCGI) uncovered irregularities with regard to recruitment and informed consent, in addition to which the independence of the Ethics Committee associated with the trial was found to be questionable. At a more general level, there have been widespread complaints of the lack of independence and the inactivity of Ethics Committees, and also, a steady rise of trial-related deaths and injuries in the country. It is against this backdrop that the DTAB (the Drugs Technical Advisory Board), in a meeting held on 10 October, 2011, decided that future drug trials will mandatorily require the affiliation of government-registered Ethics Committees comprising of at least five members trained in good clinical practices. These five members would include a doctor preferably a pharmacologist, a lawyer, an atheist, a housewife and a scientist.
Source: Pharmabiz |
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