In keeping with the Modi Government’s initiative of e-governance and ensure transparency, the Drug Controller General of India (DCGI) is planning to provide online grant of no objection certificate (NOC) to the pharma companies for conducting clinical trials soon.
Sources in the DCGI, which is an autonomous body of the Union Health Ministry said efforts are on to launch online grant of NOCs for conducting clinical trials soon, under SUGAM, an online solution for submission, application and grant of permission.
The application can be submitted and monitored online which will reduce the time of clearance.
Talking about the process, the official said that the process and document required will be the same but just that online will reduce the time required in submitting the hard copy to the office. “This will also save the applicant from the hardship of reaching to the office in person as well as ensure transparency as there will be no middlemen.
Moreover, the official added that the applicant can submit all the required documents and monitor the status of the application.
In March, the DCGI kicked off SUGAM, the online portal for licensing the import of medical device as well as for the import of drugs. Initially, the portal only provided benefit for the grant of registration certificates for import of drugs or import license of drugs and the medical device industry. Now the grant of NOC for conducting clinical trials can also be availed.
Providing the online NOC is just among several steps taken by the DCGI to streamline conducting clinical trials as well as attracting the companies for doing such tests.
In this regard, the DCGI recently done away with the restrictions on the number of clinical trials an investigator can undertake at a time, thus empowering the ethics panels 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.
The DCGI has also allowed clinical trials in less than 50-bedded hospitals. It has left on the ethics committee to examine and decide whether the clinical trial site is suitable for trial or not, irrespective of number of bed.