Addition Of New CT Site/Investigator

Summary: The up gradation of the processes and norms associated with clinical trials is a good initiative taken up by the government. This will not only improve the credibility of the process but will also improve the drug license application process as a whole.

DGCI has made some additional measures for streamlining the conductance of clinical trials in India by easing some prevalent sturdy regulations. This step has been taken to make sure the trial subjects are safe and receive appropriate preservation of their rights.

DCGI updated these measures in such a manner that it became more favorable to conduct clinical trials in India, thereby creating a very conducive environment for both the applicant and the authorities.

 This will help India with entering smoothly into a string phase of drug discovery and the proper address of novel diseases. As a concurrence, It will significantly reinforce the trust of patients in getting safe and good quality medicines at reasonable prices.

Here are the important measures are taken by DGCI for the addition of a new CT site or investigator in India.

●       DGCI eliminated the restrictions currently imposed on the iteration of clinical trials an investigator can conduct at a time. According to prevalent rules, an investigator cannot conduct more than three trials at a given time. By removal of this restriction, DGCI gave power to the ethics committee to undertake a final call on the total number of trials that an investigator can conduct at any time after assessing the various risks and complexity involved in such trials.

●       DGCI also eliminated another bottleneck by facilitating clinical trials in a hospital with less than 50 beds. Earlier, no clinical trials were permitted to be conducted in a hospital with less than 50 beds. But with these new measures, DCGI ordered the ethics committee to go for a thorough examination and then decide the feasibility of a trial site regardless of the number of beds it has. However, any such site must have proper emergency-handling arrangements along with all other facilities necessary for any specific clinical trial.

●       DGCI removed the need for an objection certificate to be obtained from DGCI for the addition of any new clinical trial site or investigator. DGCI vested the final decision into the hands of an ethics committee. After proper deliberations, the committee can approve a proposal for the addition of investigators and sites. However, the applicant will be responsible for notifying DGCI about any such addition/deletion and obtain a NOC.

●       These changes also affect the clinical trials concerned with genetic manipulation. under the Department of Biotechnology for all R-DNA related drugs like insulin, etc. The respective applicant can submit a parallel application to RGCM and DGCI thereby seeking for approval to conduct a clinical trial. But DGCI will accomplish all application scrutinization as well as permission after the RGCM clearance is received.

These amendments made to the earlier procedures will not only ease the process of clinical trials in India. But will also prove beneficial for pharmaceutical manufacturers as well as subjects undergoing such trials. Thus improving the overall process of drug product registration in India.