(9th July, 2014); The meeting of the apex committee held on 17-06-2014 under the chairmanship secretary of health and family welfare for supervising clinical trials (CTs) on new chemical entities in the light of directions of the honorable supreme court of India dated 03.01.2013
The Apex Committee was apprised that 14th and 15th meetings of the Technical Committee were held on 28.04.14 and 04.06.14 respectively, under the Chairmanship of DGHS.
The Committee was apprised that as per the direction of the Hon’ble Supreme Court made in its order dated 21.04.2014, the proposals of global CTs/ CTs of NCEs are required to be evaluated with regard to three parameters viz: assessment of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country.
The Committee noted that the Technical Committee in its 14m and 15th meetings has evaluated and recommended for 41 proposals of various categories of CTs. Out of these cases, 26 cases are global CTs/ CTs of NCEs and 15 cases are related to CTs for approval of New Drugs including fixed dose combination, subsequent new drugs and biologicals.
Out of the 26 cases,Technical Committee has recommended for approval of trials in 24 cases. In remaining 2 cases, the Committee has sought certain additional data / information.
And out of the 15 cases, which are related to CTs for approval of New Drugs including fixed dose combination, subsequent new drugs and biologicals, the Technical Committee has recommended for approval of trials in 12 cases. In remaining 3 cases, the Committee has sought certain additional data/ information.
