Govt lists steps to ensure transparency in drug trials

After uproar over 33 drugs approved in the country between 2008-2010 without carrying out clinical trials on Indian population, Government today said it has taken a number of measures to ensure transparency in the system including putting in place guidelines and committees.

Replying to a question on transparency in clinical trials on drugs in the Rajya Sabha, Minister for Health and Family Welfare Ghulam Nabi Azad said a three-member expert committee to examine the validity of the scientific and statutory basis adopted for approval of new drugs has also been constituted, which is yet to submit its report.

The Minister said the committee was formed after a Parliamentary Standing Committee on Health on the functioning of the Central Drugs Standard Control Organisation (CDSCO) said that many opinions of experts were actually written by the invisible hands of drug manufacturers.

The Committee comprises of Secretary, Department of Health Research and Director General of ICMR V M Katoch, President of National Brain research Centre P N Tandon and former director of Sanjay Gandhi Post-Graduate Institute of Medical Sciences. Lucknow, S S Aggarwal.

Listing out the steps taken to bring in transparency in the system of approving new drugs, Azad said a Committee/Core panel of experts has been set up to advise on matters relating to regulatory approval of clinical trials for investigational new drugs and another panel of experts - Cellular Biology Based Therapeutic Drugs Evaluation Committee (CBTDEC) has been set up to advise on matters of regulatory pathways leading to approval of clinical trials.

He said 12 new Drug Advisory Committees and six Medical Device Advisory Committees have been set up by the government. Besides, a general experts pool for medical device advisory committees has also been set up.

Guidelines for conducting inspection of clinical trial sites and sponsor CROs have been prepared, Azad said.