Regulator giving drug trials the go by: House panel
10 May 2012
The Central Drugs Standards Control Organisation (CDSCO), has allowed at least 33 drugs to be sold in India without proper trials between January 2008 and October 2010, a parliamentary panel looking into the functioning of the country's highest drug regulatory body said in a report.
According to the committee, on an average, the Drug Controller General of India (DCGI) is approving one drug every month, including those banned in developed countries, without trials.
The CDSCO has allowed the sale and use of several drugs, including some of the popular medicines, without undertaking clinical trials to check for their safety, the parliamentary standing committee for health and family welfare said in its report.
In a random scrutiny of 39 drugs sold in the country, the panel found that 11 of them (about 28 per cent) have been approved without conducting mandatory phase-III clinical trials.
Not only that, 13 of the drugs scrutinized (33 per cent), did not have permission for sale in any of the major developed countries (the US, Canada, Britain, European Union nations and Australia).
"None of these drugs have any special or specific relevance to the medical needs of India," the committee said.