Chemotherapy drugs made by Indian firms fail quality tests, shows study

Vital chemotherapy drugs used around the world have failed quality tests, leaving cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, the Bureau of Investigative Journalism (TBIJ, www.tbij.com) can reveal.

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The drugs in question form the backbone of treatment plans for numerous common cancers - including breast, ovarian and leukaemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much active ingredient, put patients at risk of severe organ damage or even death. "Both scenarios are horrendous," said one pharmacist. "It's heartbreaking." Doctors from multiple countries told TBIJ of the drugs in question not working as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine.

The variance found in the levels of active ingredient was alarming. In some cases, pills from the same blister pack contained different amounts. These findings expose huge holes in the global safety nets intended to prevent profit-seeking manufacturers from cutting corners, and to protect patients from bad drugs. All the while, patients and governments with stretched resources are paying the price for drugs that don't work. Generic drugs are widely used in all countries but are most crucial in those with fewer resources, where costlier treatments might be beyond reach.

Cancer is one of the biggest killers worldwide, linked to around 10 million deaths every year - roughly one in six. The burden of cancer is growing, particularly in lowand middle-income regions. In sub-Saharan Africa, for example, instances of cancer have doubled in the last 30 years. Much of the global demand for treatment is met by so-called generic drugs. These are versions of a drug that can be made once the original maker's exclusivity rights have expired, and are typically made far more cheaply. The bad drugs described in this investigation were all generics.