Ms Suneela Thatte, President, ISCR
Welcoming the recent announcements by the DCGI with regard to the cap on the number of trials per investigator and number of beds per site, the Indian Society for Clinical Research (ISCR) has said that it is a welcome move that will enhance the overall quality of clinical research being done in India.
ISCR also acknowledged the collaborative approach by the regulators in making the changes in response to stakeholder feedback.
On August 2, 2016, CDSCO released two circulars by the DCGI regarding the conduct of clinical trials in India.
As per the revised rules, the cap on the number of trials an investigator can undertake at any point in time has been removed and the Ethics Committees have ben empowered to decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted.
The cap on a minimum number of 50 beds for a clinical trial site has also been revised with the Ethics Committees now being vested with the responsibility of examining and deciding whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds.