Written By: Dr Anitha Anchan | Updated : June 10, 2014 5:56 PM IST
Union Health Minister Ghulam Nabi Azad said that 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) is being considered by the government. In a written reply to Rajya Sabha Azad said that 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.
'Government had constituted a three-member expert committee to examine the issues raised by the Parliamentary Committee,' he said while informing the House on various methods used by CDSCO to approve drugs. The committee comprising Dr. V.M. Katoch, Secretary (Department of Health Research) and Director General, ICMR, Dr. P.N. Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr. S.S. Aggarwal, former Director, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow 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 added
The Serious Adverse Events (SAEs) of deaths may occur during clinical trials due to life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure / stroke and other serious diseases or due to the side-effects of the drugs or their administration to critically or terminally ill patients. As per official data, 438 SAEs of deaths in clinical trials were reported during 2011 out of which approximately 55% are in clinical trials conducted by foreign Pharmaceutical companies and rest are in clinical trials conducted by Clinical Research Organizations (CROs), domestic pharma Companies etc. But SAEs of death due to clinical trials were 16.
12 New Drug Advisory Committees (NDAC), consisting of experts from government medical colleges and institutes, have been constituted to strengthen the approval procedures, monitoring mechanism for clinical trials as well to ensure that safety, rights and well-being of clinical trial subjects are protected, Azad said while replying to a question on deaths during clinical trials. Guidelines for conducting inspection of Clinical Trial sites and sponsor/Clinical Research Organisations (CROs) have been prepared and posted on CDSCO website, he added.
Earlier a parliamentary standing committee had pointed out the irregularities in the running of the CDSCO, commenting on the lack of lack of quality or quantity of drug inspectors, lack of clinical trials for drugs and the alleged nexus between big pharmas, doctors and drug agencies.
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