Applications for grant of NOCs for BA/BE studies made ‘online only’ by CDSCO

As a part of its e-governance initiatives, the clinical research regulator will accept only online application from 13 September 2016 for issue of NOCs for conducting BA/BE studies clinical trials

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New Delhi: The Central Drugs Standard Control Organisation (CDSCO) will accept only online applications from applicants seeking no objection certificates (NOCs) for conducting BA/BE studies for export purposes.  The order is expected to come into effect from September 13, 2016. The applicants have to register themselves on the site prior to submission of the applications.

Earlier in November 2015, CDSCO had launched, an online portal for rendering online services. During the first phase, the top regulator accepted submission of applications for import and registration of drugs and medical devices. Now applications for grant of NOC for conducting clinical trials can also be availed.

This online submission initiative is in pursuance of its e-governance implementation program SUGAM. The new online application system is expected to provide an opportunity for user to apply for the grant through online system. It also provides an option to track the status of application online through an application reference number provided by the system at the time of submitting the application.