Andhra Pradesh Drugs Control Administration has stressed the need to amend the Drugs and Cosmetics Act 1940 and the present rules to sanction powers to monitor and control clinical trials at the state level. Drugs and Copyright Director General of the state R P Meena told AIR correspondent that dual licensing system should be enforced to control and monitor various Clinical Research Organisations on the lines of Blood Banks and Vaccines in the state. Referring to the clinical trials being conducted by mushrooming CROs, the Director General said the drug control officials have been remaining silent spectators as they do not have any powers to monitor clinical trials. Referring to the recent media reports about some companies conducting clinical trials, Mr Meena said ethics committees of the CROs should be made accountable to the Drug Control Administration at state level. The State Human Rights Commission has also directed the DG Drugs and Copy Rights to collect affidavits within one month from the pharma companies about the clinical trials they are undertaking.
News On AIR | July 21, 2011 2:32 PM
Drugs Control Administration stresses need to amend the Drugs and Cosmetics Act