Centre permits 26 new drugs for sale sans trials
19 Aug 2013 5:32 AM IST
Notwithstanding strong warnings by the parliamentary standing committee on health, new drugs continue to be approved for marketing in the country without holding any clinical trials on Indian patients to test their safety and efficacy.
Sources in the health ministry admit that as many as 26 new drug molecules have been approved since 2010 without testing them through drug trials on local populations.
While eight new drug molecules of biologicals and non biologicals were approved by the country's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), last year, two have already been allowed for sale so far this year.
As many as 13 such new drugs were approved in 2010 and three more were approved in 2011. Officials of the health ministry say that new drugs have been approved without clinical trials after taking adequate caution. They said such drugs are the ones used in medical emergencies and where trials are not possible in the country due to less number of patients and in cases where diseases are rare.
Sources in the health ministry admit that as many as 26 new drug molecules have been approved since 2010 without testing them through drug trials on local populations.
While eight new drug molecules of biologicals and non biologicals were approved by the country's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), last year, two have already been allowed for sale so far this year.
As many as 13 such new drugs were approved in 2010 and three more were approved in 2011. Officials of the health ministry say that new drugs have been approved without clinical trials after taking adequate caution. They said such drugs are the ones used in medical emergencies and where trials are not possible in the country due to less number of patients and in cases where diseases are rare.
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