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Strengthening the Regulation and Monitoring of Clinical Trials

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In order to strengthen the regulation and monitoring of clinical trials in the country, the following measures have been taken by the Government: 

i. Twelve New Drug Advisory Committees (NDACs) and Six Medical Device Advisory Committees (MDACs) have been constituted to evaluate clinical trials proposals. These committees consist of leading experts from Central and State Government medical institutions. 

ii. A draft notification has been issued for incorporation of a new rule in the Drugs & Cosmetics Rules, 1945, which provides the following: 

a. Medical treatment and financial compensation to the trial subjects in case of trial related injury or death; 

b. Procedure for payment of financial compensation; 

c. Enhancement of responsibilities of Ethics Committee (EC), Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths and such information is provided to DCG(I). 

d. Amendment of the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects. 

iii. All clinical trials, the permission for which have been granted by the office of DCG(I) on or after 15th June 2009, have to be mandatorily registered on the clinical trial registry at www.ctri.in of Indian Council of Medical Research (ICMR). 

iv. CDSCO has issued guidelines for conducting inspection of clinical trial sites and Sponsor/Clinical Research Organisations (CROs). 


Source : Press Information Bureau
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