Govt. revises regulations for conducting clinical trials

Health Care Comments Off

The Central Drug Standard Control Organization (CDSCO) has revised rules for conducting clinical trials in the country.

· The CDSCO has done away with the earlier restriction of three clinical trials per investigator at any given period of time. The Circular File No. 12-01/14 – DC (Pt. 47) dated 2.8.16 issued by the CDSCO in this regard states: “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided that Ethics Committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake.”

· Regulations for hospitals conducting clinical trials have also been eased. In its circular File No. 12-01/14 – DC (Pt. 47) dated 3.8.16, the CDSCO said, “As regards requirement of NOC from DCGI for addition of new clinical trial site or investigator in clinical trial, 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. However, the applicant would inform DCGI about any such addition / deletion and thereafter, if no objection was received from DCGI, it would be deemed to have concurrence of CDSCO.”

· A minimum number of beds is no longer a requirement for hospitals seeking to conduct a research. The CDSCO has revised this restriction vide a circular File No. 12-01/14 – DC (Pt. 47) dated 2.8.16 as follows: “As regards condition that no clinical trial shall be conducted at site having less than 50 bedded hospital, it has been decided to revise this condition and it is further decided that Ethics Committee shall examine and decide whether the clinical trial site is suitable for trial or not irrespective of number of bed. However, it was also suggested that site shall have emergency rescue and care arrangements along with all other necessary facilities required for that particular clinical trial.”

(Source: CDSCO)