MEASURES TAKEN BY DCGI
Earlier requirement of Audio-Visual (AV) recording of Informed Consent Process (ICP) of all subjects in all clinical trials have been revised and the Audio-Visual (AV) recording of ICP has been made mandatory only in case of vulnerable subjects in clinical trials of New Chemical Entity (NCE)/New Molecular Entity (NME) and in case of clinical trial of anti-HIV and anti-Leprosy drugs, only audio recording of the ICP is required.
The Drugs and Cosmetics Rules have been amended on March 16, 2016 providing that no permission is required from DCG (I) for conduct of clinical trial of approved drug formulation for new indication, route of administration etc. for Academic / Research purposes subject to conditions that the trial has been approved by the Ethics Committee and the data generated will not be submitted to the regulatory Authority for new drug approval purpose and certain other conditions.
Earlier restriction that number of clinical trials an Investigator can undertake should be not be more than three has been removed providing that the number of clinical trials should be decide by the respective Ethics Committee. Earlier requirement of at least 50 bedded hospitals for conduct of clinical trial have been revised providing that centres irrespective of number of beds, could be allowed to conduct clinical trials after the Ethics Committee approval.
For addition of new clinical trial site or investigator in clinical trial, no NOC from DCG (I), in the normal course, would be necessary. The respective Ethics Committee after due diligence can approve such proposals for addition of site(s) and investigator(s). However the applicant would inform the DCG (I) about any such addition/deletion and if, no objection was received from DCG (I), it would be deemed to have concurrence of CDSCO.