The Central Drugs Standard Control Organization (“CDSCO”) has notified that physical application for registration and re-registration of Ethics Committee will not be accepted from 1st September, 2018 onwards.
Background
CDSCO had previously launched various services through SUGAM portal (www.cdscoonline.gov.in) on 14th November 2015, in pursuance of implementation of e-Governance.
In reference to the trail mail, we had reported that CDSCO had issued a draft of New Drugs and Clinical Trials Rules, 2018 (“Draft Rule”) wherein it has been proposed to make an Ethics Committee mandatory for an institution or organization which intends to conduct clinical trial or bioavailability study or bioequivalence study. The Draft Rule mandates the Ethics Committee to be registered with the Drugs Controller General of India.
According to the present notification, the application for registration and re-registration will be accepted through SUGAM portal, online. The SUGAM portal will further reduce time and transaction costs that the stakeholders incur while filing physical applications.
Source: Central Drugs Standard Control Organization
