The Central Drug Standard Control Organization (CDSCO) has revised rules for conducting clinical trials in India. On 2nd August; CDSCO released 2 circulars by the Drug Controller General of India (DCGI) regarding the conduct of clinical trials . The circular states,
- The number of trials an investigator can undertake at any point in time has been removed
- The Ethics Committees have been empowered to decide on how many trials an examiner can undertake after examining the risk and complexity involved in the trials being conducted.
Rules for hospitals conducting clinical trials have also been eased. Requirement of NOC from DCGI for addition of investigator in clinical trial or new site for clinical trial, it was decided in the meeting that the respective Ethics Committee after due diligence can approve proposals for addition of site, investigator and no NOC from Drug Controller General of India in normal course, should be necessary. However, the applicant would inform DCGI about any such addition / deletion and thereafter, if NOC was received from DCGI, it would be deemed to have concurrence of CDSCO
A minimum number of beds are no longer a requirement for hospitals seeking to conduct a research. A clinical trial site of minimum number of 50 beds has also been revised with the Ethics Committees now being vested with the responsibility of testing and determining whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds.
ISCR also acknowledged the collaborative approach by the regulators in making the changes in response to stakeholder feedback.
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