The Indian Health ministry has taken different steps to ease the conductance of clinical trials in India by creating strong regulatory platform for ensuring safety, rights and well beings of the clinical research.
Based on field experience, it has become imperative to bring clarity on certain scientific issues which have become bottlenecks in the area of clinical trials in the country. This issues were under deliberations/consultations with national / international; associations/institutions/subject experts for couple of months.
In the notice Dr. G. N. Singh, Drugs Controller General (India) said that in order to utilize full potential of talented human resource and infrastructural facilities available in this area, it has been decided to consolidate functions in such a way that India may become a favourable destination for doing clinical trials and create conducive environment for pharma sector to enter swiftly into Drug Discovery and Research phase to address issues of emerging diseases for its people and assist the patients of the continent to get safe, efficacious and high quality medical products at affordable prices mainly related to neglected diseases.
Health ministry has taken few initiatives to ensure safety of Clinical trials. Prior, there was restriction of conducting three clinical trials per investigator. Health Ministry has removed this restriction & it is further decided that Ethics Committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake.
There was a rule that no clinical trial shall be conducted at site having less than 50 bedded hospital, it has been decided to revise this condition & it is further decided that Ethics Committee shall examine & decide whether the clinical trial site is suitable for trial or not irrespective of number of bed.
Prior NOC was required from DCGI for addition of new clinical trial site or investigator in clinical trial, now it was decided in the meeting that the respective Ethics Committee after due diligence can approve proposals for addition of site(s) and investigator(s) and no NOC from DCGI in the normal course, should be necessary. However, the applicant would inform DCGI about any such addition /deletion and thereafter, if no objection was received from DCGI, it would be deemed to have concurrence of CDSCO.
It was also decided in the meeting that the applicant may submit parallel application to RCGM and DCGI seeking approval to conduct clinical trial. However, DCGI shall complete the scrutiny of application and issue permission, only after RCGM clearance was received.
