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 Organization (CDSCO), has asked for two more months to submit its report to the government.

Dr V M Katoch, who is a member of the three-member committee, said that the committee could not complete the report within the stipulated two months time and it has asked for time till August to complete the report. The committee is analysing each and every aspect to make the procedure of new drug approvals more transparent in the country, Dr Katoch, who is the secretary, department of health research and DG, ICMR, said. Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, is the other member of the committee.

The three-member committee under Dr PN Tandon, president, National Brain Research Centre, Department of Biotechnology, Manesar, was constituted by the health ministry in the wake of Parliamentary Standing Committee's striking criticism of the functioning of the CDSCO.

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. The committee has been asked to submit its report within a period of two months.

The 59th Report of the Parliamentary Standing Committee on the functioning of the CDSCO has pointed out certain irregularities particularly in the area of approval of new drugs without clinical trials in the country. It 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.

In a random scrutiny, the Parliamentary Standing Committee on Health headed by Brajesh Pathak has 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, tabled in Parliament in the first week of May this year, 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.