Union Health Minister Ghulam Nabi Azad has claimed that the Centre had taken a number of measures in the past to strengthen the regulation and monitoring of clinical trials in the country.
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, he disclosed in the Parliament on Friday.
A draft notification has been issued for incorporation of a new rule in the Drugs & Cosmetics Rules, 1945, which provides clauses for medical treatment and financial compensation to the trial subjects in case of trial related injury or death, procedure for payment of financial compensation, and enhancement of responsibilities of Ethics Committee (EC), Sponsor and 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), said an official release.
Amendment was made in 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, he said.
“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). CDSCO has issued guidelines for conducting inspection of clinical trial sites and Sponsor/Clinical Research Organisations (CROs),” the release said.