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House panel finds huge irregularities in drug trials

Huge irregularities have surfaced in the functioning of Central Drugs Standards Control Organisation (CDSCO), with a parliamentary panel pointing out that at least 33 drugs have been allowed to be sold in India without proper trials.

According to a report by the Parliamentary Standing Committee on Health, 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 they are ‘really effective and safe’ for them.

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’.

‘In case of clevusine (of Phamasset Inc.), three experts (a professor of medicine of AIIMS, New Delhi, a professor of medicine of KBN. Medical college, Gulbarga, and a professor of medicine of RG Kar Medical College, Kolkata) located at different places thousands of miles apart from each other, sent word to word identical letters of recommendation,’ it said pointing out one of many such cases.

‘Is the committee mistaken in coming to the conclusion that all these letters were collected by the interested party?’ it asked, adding that the cases pointed to an ‘apparent nexus’.

The panel has also asked the ministry to conduct an enquiry and ‘take appropriate action against the officials’.

Among the 33 drugs which have been allowed without trial, the panel says, the ministry in the information given to the panel, missed name of two controversial drugs, ‘ademetionine’ and ‘FDC of pregabalin’. Pregabalin is not allowed to be sold in developed countries.

The panel also pointed out that out of randomly picked drugs which the panel wanted to check for the record of trials, the ministry could not provide the files of three drugs - ‘pefloxacin, lomefloxacin, and sparfloxacin’. Strangely, all these cases also happened to be controversial drugs; one was never marketed in US, Canada, Britain, Australia, and other countries with well developed regulatory systems while the other two were discontinued later on, it added.
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