The Technical Committee and the Apex Committee, the two high-level panels to supervise the clinical trials sector, have denied clearance to several proposals of clinical trials of new drugs, including fixed dose combinations, medical devices and global trials, even though the new drug advisory committees had recommended them for permission.
The Technical Committee first evaluated 47 proposals, which were forwarded by the NDACs which are supposed to go into the details with the help of experts. However, the technical committee cleared only 28 proposals out of the total 47. Later, the Apex Committee headed by the Health Secretary also accepted the recommendations by the technical committee to deny permission to 19 proposals on various grounds.
The evaluation was done by the technical committee keeping in view the risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option and unmet medical need in the country, sources said. The rejected proposals include the global clinical trials request from companies like Novo Nordisk, Wockhardt, Novartis, Roche, Reliance Life Sciences and Cadila Pharmaceuticals.
As many as 11 proposals were recommended by the NDAs, though the pharmacologist from among the experts was not present at the meeting for evaluation. The technical committee however refused to give clearance and directed for getting written opinion of the pharmacologist. In the case of one proposal, the committee asked the CDSCO to get written opinion of the pharmacologist and haematologist.
Regarding an application (for LIK066) from Novartis, the technical committee asked the NDAC to re-deliberate the matter in view of the large number of exclusion criteria including the feasibility for enrolling subjects for the trial. In the case of the application by Novo Nordisk India Pvt Ltd (for insulin degludec), the apex committee noted the firm proposed to conduct study on 1000 patients. Hence the committee recommended that the firm should submit their plan to enroll so many patients in nine centres within one year.
The committee asked the NDACs to deliberate again two proposals from Cadila (for mycobacterium w and allogenic pancreatic cancer vaccine ) involving oncologists as the trials were proposed to be conducted in cancer patients.