Taking note of the 59th Report of the Parliamentary Standing Committee on the functioning of the Central Drugs Standard Control Organization (CDSCO), Union Minister of Health and Family Welfare in Ghulam Nabi Azad has constituted a committee of three experts to look into the procedure of drug approvals.
The committee comprises of Dr V M Katoch, secretary and DG, ICMR, Dr P N Tandon, president, National Brain Research Centre, Department of Biotechnology, Manesar and Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, said an official release here on Friday.
The Committee has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials, outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO. The Committee has been asked to submit its report within a period of two months.
“The Parliamentary Standing Committee Report has, inter alia, 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, spurious sub-standard drugs, etc. The Report has also pointed out certain irregularities particularly in the area of approval of new drugs without clinical trials,” said the release.