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 VM 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.

"All the 38 approvals granted under existing provisions, as identified by the Parliamentary Standing Committee (and CDSCO), and also others, if any, shall be re-reviewed by the respective newly constituted New Drug Advisory Committees as per revised provisions and the SoPs laid down by them.

"It would be prudent to take any action on already approved/licensed drugs, such as withdrawal of the approval etc, only after such a re-review. The NDACs may ask additional desired information from the manufacturers as deemed necessary. This should be carried out in a time bound fashion," the Committee said in its report.

It also said all future approvals/licencing of drugs without clinical trial in India should be regularly monitored and exemptions be granted only under exceptional circumstances.

It said exemptions should be granted only if the drug is needed for a sudden epidemic or for a rare disease where adequate number of cases may not be available within a reasonable time frame.

It also asked the government to constitute a group of medical professionals and legal experts to revise the existing rules for granting approval to drugs without conducting trials on Indians.

The Expert Committee headed by Katoch and comprising PN Tandon, president of National Brain Research Centre, Manesar, and SS Agarwal, former Director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, also suggested review of existing rules for granting approval of drugs in the country.

The expert panel set up by the Union Ministry of Health and Family Welfare, also sought complete streamlining of the Central Drugs Standard Control Organization (CDSCO).