By IANS,
New Delhi : After a report from a parliamentary standing committee pointed out huge irregularities in the functioning of the Central Drugs Standards Control Organisation (CDSCO), Health Minister Ghulam Nabi Azad Friday announced that a three-member committee would examine the issue.
The committee would comprise of Indian Council of Medical Research director-general V.M. Katoch, National Brain Research Centre president P.N. Tandon, and Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, former director S.S. Aggarwal. It will submit its report in two months.
The committee will 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, a statement issued here said.
According to a report by the Parliamentary Standing Committee on Health, huge irregularities were found in the functioning of the Central Drugs Standards Control Organisation (CDSCO). The parliamentary panel pointed out that at least 33 drugs have been allowed to be sold in India without proper trials.
The report says at least 33 drugs were approved for sale in India during 2008-10 without conducting trials on Indian patients, and there was no scientific evidence to show that these drugs were “really effective and safe” for use.
The panel also pointed out that there was an “apparent nexus” between drug manufacturers and experts, whose opinion matters “so much in the decision making process at the CDSCO”.
“On an average, the DCGI (Drug Controller General of India) is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination,” the panel observed.
It also gave examples where the opinions of experts were based simply on “personal perception”.