The Drugs Controller General of India (DCGI) Dr GN Singh has initiated a slew of measures to streamline for conducting clinical trials in the country by creating strong regulatory platform for ensuring safety, rights and well beings of the trial subjects.

The DCGI decided to consolidate functions in such a way that India may become a favourable destination for doing clinical trials and create conducive environment. That may enable the sector to enter swiftly into drug discovery and address issues of emerging diseases and assist the patients to get safe and high quality medicines at affordable prices.

In this regard, the DCGI already removed the restrictions on the number of clinical trials an investigator can undertake at a time. At present, no investigator should conduct more than three trials at any given period of time. Removing the restriction, the DCGI empowered the Ethics Committee to take a final call on the number of clinical trials an investigator can do at any given time after examining the risk and complexity involved in the trials.

Close on the heels of this decision, the DCGI removed another bottleneck by allowing clinical trials in less than 50-bedded hospitals. Currently, no clinical trials can be conducted at site having less than 50-bedded hospitals. After doing away with this provision, the DCGI decided that the Ethics Committee will examine and decide whether the clinical trial site is suitable for trial or not, irrespective of number of bed. However, the DCGI suggested that the site should have emergency rescue and care arrangements along with all other necessary facilities required for that particular clinical trial.

In yet another measure, the DCGI also removed the bottleneck of requirement of no objection certificate (NOC) from DCGI for addition of new clinical trial site or investigator in clinical trials. Instead, the DCGI decided that the respective Ethics Committees after due deliberations can approve proposals for addition of sites and investigators and no NOC from DCGI, in the normal course, should be necessary. However, the applicant would inform DCGI about any such addition or deletion and thereafter, if no objection is received from DCGI, it would be deemed to have concurrence of CDSCO.

The DCGI measures to streamline the conductance of clinical trials do not end there. As regards requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like insulin, monoclonal antibody, etc, it was decided that the applicant may submit parallel application to RCGM and DCGI seeking approval to conduct clinical trial. However, the DCGI shall complete the scrutiny of application and permission only after RCGM clearance was received.