Panel finds irregularities in drugs approval, seeks review

A government panel has found irregularities in approval of 38 drugs without clinical trials on Indians with nine of them cleared by drug controller without reference to any expert and said the exemptions "appear to be due to pressure from pharma companies".
The expert committee, set up by the government to look into irregularities in approving drugs, has recommended that all 38 such approvals, shall be reviewed by the newly constituted New Drug Advisory Committees.
The Parliamentary Standing Committee on Health had in its 59th Report pointed out that 38 drugs were approved by the Drug Controller General of India (DCGI) without conducting clinical trials on Indians between 2001 and 2010.

"Such approval was sporadic till 2007 (only 4 drugs given exemption in 7 years). The spurt started in 2008 when six drugs got exemption and the number has risen to 14 each in 2009 and 2010. The reasons are not clear but appears to be due to pressure by the pharmaceutical companies," the Expert Committee, headed by Secretary, Department of Health research and Director General ICMR V M Katoch, observed in its report.
"The DCGI has approved nine of these drugs without reference to any expert between 2006 and 2010," the Committee further observed, adding that in several cases the opinion of experts as forwarded by the companies has been accepted even when most such "experts" were not from the academic institutions and in many cases the contents of letters were identical.

"The experts have recommended waiver of clinical trials only in six cases. In all other cases the recommendation is for early marketing. They have not recommended that the procedure be short circuited. The decision appears to have been taken by DSGI," the expert Committee observed.
The Committee report submitted to the government late last year was obtained under RTI by an Indore-based government doctor Anand Rai, actively involved in clinical trial issues.