26 new drugs permitted for sale without trials in India

New Delhi: 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.

They said that it is only after expert opinion that such drugs are being approved.

Importantly, the approval to 26 new drugs sans local trials comes within two years of the parliamentary panel exposing how 38 new drugs were approved without trials on Indians between January 2008 and October 2010.

The committee had while coming down heavily on the drug controller for allowing untested drugs to be used in India said that many such new drugs did not fall in the category of medicines meant for medical emergencies.

The report had focused nation`s attention on the poor state of drug regulation in India and sought immediate corrective measures.

Following the report, the health ministry has introduced several new measures aimed at ensuring efficacy and safety of drugs.

The CDSCO has also written to states to prove within 18 months the safety and efficacy of all such fixed dose combination drugs which have been approved directly by states without seeking prior approval of the apex drug regulator.

The ministry is ready with a new Drugs and Cosmetics Act which deals with clinical trial regulation in a separate chapter.


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