New Delhi: Government is considering the report of an expert committee set up to examine the issue of alleged approval of drugs without clinical trial by Central Drugs Standard Control Organisation (CDSCO), Union Health Minister Ghulam Nabi Azad said today.
"The Department related Parliamentary Standing Committee in its Report on the functioning of CDSCO has raised various issues pertaining to functioning of the organisation, including alleged approval of drugs without clinical trials," Azad said in a written reply to Rajya Sabha.
Informing the House on various methods used by CDSCO to approve drugs, he said, "Government had constituted a three- member expert committee to examine the issues raised by the Parliamentary Committee."
The committee has experts from Department of Health Research, ICMR, National Brain Research Centre, Department of Biotechnology, etc.
The panel was formed to examine the validity of scientific and statutory basis adopted for approval of new drugs without Phase-III clinical trials on Indian population, he said.
Replying to a separate question on deaths during clinical trials, Azad said 12 New Drug Advisory Committees (NDAC), consisting of experts from government medical colleges and institutes, have been constituted to advise CDSCO in matters related to approval of clinical trials and new drugs.
Guidelines for conducting inspection of Clinical Trial sites and sponsor/Clinical Research Organisations (CROs) have been prepared and posted on CDSCO website," he said.