The Dr PN Tandon-headed expert committee, constituted by the union health ministry in May this year, to look into the procedure of new drug approvals by the Central Drugs Standard Control Organisation (CDSCO), has submitted its much awaited report to the health ministry.

Dr V M Katoch, one of the members of the three-member committee and secretary, department of health research, confirmed that the committee has submitted its report to the ministry. However, he did not reveal further details about the report. “The committee has recommended several structural changes, and the report is with the ministry. After examining the report, the ministry will soon place the report before Parliament,” said Katoch, who is also the director general of ICMR.

The Dr Tandon-headed panel was constituted by the union health ministry in May this year in the wake of Parliamentary Standing Committee's striking criticism of the functioning of the CDSCO. In its 59th Report, the Parliamentary Standing Committee, headed by Brajesh Pathak, had pointed out certain irregularities particularly in the area of approval of new drugs without clinical trials in the country. It had, 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.

In a random scrutiny, the Parliamentary Standing Committee on Health headed by Brajesh Pathak had found that as many as 33 drugs were approved without clinical trial on Indian patients by the Drug Controller General of India (DCGI), during the period of January 2008 to October 2010.

The Parliamentary committee report had pointed 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Drugs Control Organisation and medical experts in granting approvals to new drugs and said drugs banned, discarded or withdrawn in developed countries are in circulation in India.

As a knee-jerk reaction, the health ministry constituted the three-member expert committee under Dr PN Tandon, (president, National Brain Research Centre, Department of Biotechnology, Manesar), to look into CDSCO affairs.  Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, is the third member of the committee.

The committee was 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 to suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.