The three-member Committee of experts comprising Director General ICMR V M Katoch, President of National Brain Research Centre, Department of Biotechnology, Manesar P N Tandon and former Director of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, S S Aggarwal, has been asked to submit its report within two months.
The Committee has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without conducting clinical trials, outline appropriate measures to bring about systemic improvements in processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.
The report has pointed out serious irregularities and serious lapses in clearing new drugs in the grant of approval to new drugs without conducting clinical trials in India.
It also pointed out to a collusive nexus between drug manufacturers, officials of Drugs Control Organisation and medical experts in granting approvals to new drugs and said drugs banned, discarded or withdrawn in developed countries are in circulation in India.
The Parliamentary Standing Committee Report has made recommendations and observations on various aspects such as organisational structure and strength of CDSCO, approval of new drugs, banning of drugs, approval of fixed dose combinations, pharmacovigilance and spurious/sub-standard drugs.
