Drug Controller General of India (DCGI) with the approval of the Ministry of Health and Family Welfare, vide Order no. F. No. DCGI/Misc./2014(132) dated 05 September, 2014 directed all the Sponsors/CROs/ Medical Institution and other Stakeholders involved in the conduct of Clinical Trial in the country to include following information in their Clinical Trial Application with immediate effect i.e. (i) Assessment of risk versus benefit to the patients, (ii) Innovations vis-à-vis existing therapeutic options, (iii) Unmet medical need in the country. The above said direction of inclusion of these three parameters in the Clinical Trial Application by DCGI is in furtherance of the Hon'ble Supreme Court Order dated 21.10.2013 in the matter of W.P (C) No. 33/2012 of Swasthya Adhikar Manch, Indore & Anr. V. Ministry of Health and Family Welfare & Ors. with W.P (C) No. 779/2012 regarding Clinical Trials, wherein it was directed that all the Global Clinical Trials (GCTs)/ New Clinical Trials (NCEs) should be evaluated having regard to the three parameters (as mentioned above) in the Clinical Trial Application.
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