ISCR Urges Centre to Engage State Drug Control Depts to Monitor Clinical Trials
In a latest development the Indian Society of Clinical Research (ISCR) has seriously stressed the central drug control authorities to permit state drugs control departments. By this they can effectively monitor the clinical trials conducted in respective region. However it is still under approval for human studies with prominent purview of the Drugs Controller General of India office. It is expected that the state drugs control department across the country require to be roped in close watch on the same.
They are also suggesting that clinical trial site inspection would oversee patient recruitment and proper conduct of these human studies happening in each state. So they require coming under the purview of the local drugs control department and it cinch be facile to scrutinize every step. Eventually this potent call for extensive training of the drug inspectors associated in the professional supervision of clinical trials. As a matter of concern this training imparted must not be just from CDSCO but from global regulatory agencies like the US FDA, EMA and MHRA. So that essentially requires instructing and arming them with special skills in clinical trial inspections.