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'Regulation for conducting clinical trials, revised'

The Central Drug Standard Control Organization has revised rules for clinical trials in the country

Policy Pulse
Publish Date: Aug 5 2016 2:06PM | Updated Date: Aug 5 2016 2:06PM

'Regulation for conducting clinical trials, revised'

The Central Drug Standard Control Organization (CDSCO) has upgraded the earlier restriction of three clinical trials per investigator at any given period of time.


The circular file issued by the CDSCO in this regard states that restriction regardomg no investigator shall conduct more than three trials at any given period of time, has been decided to remove. It is decided by the ethics committee after examining the risk and complexity involved in the trial being conducted.


Regulations for hospitals conducting clinical trials have also been eased. In their circular file, the CDSCO said, “The requirement of NOC from DCGI for addition of new clinical trial site or investigator in clinical trial is also changed.”


“It was decided in the meeting that the respective ethics committee, after due diligence, can approve proposals for addition of site(s) and investigator(s) and no NOC from DCGI in normal course, should be necessary,” the comments by CDSCO stated.


However, the applicant would inform DCGI about any such addition or deletion and thereafter, if no objection was received from DCGI, it would be deemed to have concurrence of CDSCO.


A minimum number of beds also no longer a requirement for hospitals seeking to conduct a research. The CDSCO has revised this restriction saying, “The condition of having more than 50 beds in hospital is also changed.”


“From now on the committee will decide whether the clinical trial site is suitable for trial or not irrespective of number of bed. However, it is suggested that site shall have emergency rescue and care arrangements along with all other necessary facilities required for the trials,” the organization said.